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Negotiation Training for Caregiver Communication in AD

Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04837937
Enrollment
132
Registered
2021-04-08
Start date
2023-09-01
Completion date
2024-06-17
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Cognitive Impairment

Keywords

Family caregiver, Negotiation, Dispute resolution, Conflict communication

Brief summary

The purpose of this study is to design a Negotiation and Dispute Resolution (NDR) training intervention to improve communication and address resolution of conflicts that family caregivers of patients with cognitive impairment and/or Alzheimer's Disease (AD) frequently experience.

Detailed description

The goal of this study is to design a Negotiation and Dispute Resolution (NDR) training intervention to improve communication and address resolution of conflicts that family caregivers of patients with cognitive impairment and/or Alzheimer's Disease (AD) frequently experience. Specifically this study will: Aim 1: Employ a caregiver (user)-centered design approach to modify and tailor a negotiations and dispute resolution (NDR) training intervention to support communication skills of family caregivers of adults with AD. Aim 2: Utilizing Multiphase Optimization Strategy (MOST), conduct a randomized controlled trial of the NDR intervention that targets better communication between caregivers and health teams to determine the feasibility of delivering the intervention, and derive estimates of the effect of 3 intervention components on changes in patient-centered outcomes at post-intervention and follow-up. Exploratory Aim 3: Explore if intervention components (lectures/exercises) interact to change communication between caregivers and health care teams at post-intervention and follow-up.

Interventions

BEHAVIORALCaregiver vs. Patient [Beginner]

Participants will be assigned a 'Caregiver vs. Patient' \[Beginner\] online negotiation exercise. All participants will complete this exercise, so it will serve as the constant.

BEHAVIORALCaregiver vs. Caregiver

Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.

BEHAVIORALCaregiver vs. Physician

Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.

BEHAVIORALCaregiver vs. Patient [Advanced]

Participants will be assigned a 'Caregiver vs. Patient \[Difficult\]' online negotiation exercise. This exercise is advanced compared to the constant since it involves negotiating more than one conflict.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

Intervention model description

The randomized controlled clinical trial has a full factorial testing 3 components at 2 levels each (on and off). Individuals will be randomized to 1 of 8 experimental conditions. Participants can be assigned to intervention (Yes) or control (No) conditions for each component. All participants will receive a caregiver-patient negotiation exercise so that no participant gets an inactive placebo.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Speak/read English; * Currently provide care-giving support (e.g. emotional, social, physical, task-related) to an adult over the age of 65; * Currently provide care-giving support at least 1 hour per week (e.g. may include grocery shopping, scheduling appointments, and transportation); * Currently involved in any decision-making related to the healthcare and support of this adult over the age of 65; * Score \>2 on the 8-item Informant Interview to Differentiate Aging and Dementia (AD8); * Access to and the ability to use the internet to complete a series of online activities; and * Have a valid email address or the willingness to create one to access during the study

Exclusion criteria

* Less than 21 years old * Unable to speak and read English

Design outcomes

Primary

MeasureTime frameDescription
Change in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (pre-intervention) and 1 Month Post-interventionCaregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL). The measure is a 9-item panel rating how caregivers experience feelings of positive affect and well-being. Responses are Likert scales, scored 1-5, Never (1), Rarely (2), Sometimes (3), Often (4), Always (5). Responses are summed for a final score and converted to a t-score per Neuro-QoL manual scoring conventions. Population mean T-Score is 50 and SD is 10. Higher scores indicate higher levels of Positive Affect and Well-Being. Positive change represents an increase in positive affect/well-being, and negative change represents a decrease.

Secondary

MeasureTime frameDescription
Change in PROMIS Anxiety Score1 months post-baselineThe PROMIS Adult Emotional Distress-Anxiety scale measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), and hyper-arousal (tension, nervousness, restlessness) in respondents during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). We deployed the four item short form, with scores ranging from 4-20, with higher scores indicating greater severity of anxiety. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.
Change in Zarit Caregiver Burden Score1 month post-baselineThe Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire (Zarit, Reever & Bach-Peterson, 1980). The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). The total score range is 0 to 88. Increasing scores indicate increasing burden. Scores were measured at baseline and at 1 month post-intervention and a change score was computed for each participant. These change scores are averaged to produce the by-condition mean change in burden score. Positive results indicate an increase in burden, and negative results indicate a decrease in burden.
Change in PROMIS Fatigue Score1 month post-baselineThe PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. We deployed PROMIS Fatigue Form 7a, a seven item likert scale panel ranging from 1=never to 5=always. Scores range from 7-35. Higher scores indicate more fatigue. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.
Change in PROMIS Short Form General Self Efficacy T Score1 months post-baselinethe PROMIS General Self-Efficacy - Short Form is a four item panel which measures confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. The four items are 1-5 Likert scales, 1=never, 5=always. Minimum score is a 4 and maximum is a 20. Raw Scores are converted to T scores with mean 50 and SD 10 per the PROMIS scoring manual. Higher score=greater self efficacy.
PROMIS Short Form Emotional Support T Score at BaselineBaseline MeasurePROMIS Emotional Support - Short Form. The PROMIS Emotional Support item bank assesses perceived feelings of being cared for and valued as a person; having confident relationships. The short form 6a deployed here is a 6 item likert scale panel, which assesses responses as 1=never and 5=always in response to item statements. Minimum score is a 6 and maximum is a 30. Higher scores indicate greater feelings of emotional support. The raw score is rescaled per the PROMIS scoring manual into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.
Change in PROMIS Satisfaction With Social Roles/Activities Score1 months post-baselineThe PROMIS adult Satisfaction with Social Roles and Activities item bank assesses satisfaction with performing one's usual social roles and activities (e.g., I am satisfied with my ability to participate in family activities). Short form 8a is deployed here. This is an 8 item likert scale panel, with responses rated 1=never and 5=always. Scores range from 8 to 40. Higher scores indicate greater satisfaction with social roles and activities. The raw score is rescaled per the PROMIS scoring manual into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.
Change in Neuro-QoL Caregiver Specific Anxiety Score1 month post-baselineTBI-CareQOL is a set of self-report measures within the Neuro-QoL™ measurement system that assesses the health-related quality of life (HRQOL) of caregivers of adults with traumatic brain injury (TBI). Among these is the Caregiver specific anxiety measure. This is a six item likert panel with responses rated 1=never and 5=always, for a combined score range of 6-30. Higher scores indicate greater levels of anxiety. Raw scores were rescaled per the Neuro-QoL scoring manual into T-Scores with a mean of 50 and an SD of 10. Difference between T-score at baseline and 1-month was computed for each participant to produce a change score, and these change scores are averaged to produce per condition means.

Other

MeasureTime frameDescription
Exercise Completion Rate2 weeks post-baselineMeasuring the feasibility of the intervention by assessing completion of negotiation training exercises.
Participant Retention Rate at 3 Months Post-baseline3 months post-baselinePercentage- numerator=# of participants who completed 3 month post-baseline assessment, denominator=# of participants randomized to a condition.
System Usability Scale Score2 weeks post-interventionMeasuring the feasibility of the intervention by measuring the usability of the intervention as measured by the System Usability Scale (SUS), a 10-item measure of usability. SUS is a 10-item likert panel, with scores ranging from 1-5. Scores are tabulated by converting raw scores by subtracting 1 from each raw score and then summing per the scoring manual: summed score=2.5\*(20+(sum of odd numbered questions)-(sum of even number questions)). The minimum and maximum values are thus 50 and 100. Higher scores indicate greater usability.
USE Acceptability Score2 weeks post-interventionThe USE Acceptability score measures the acceptability of the intervention, employing an 8-item panel of 1-7 Likert scale questions, with a 0 option for not applicable. Raw score is converted to 0-100 score as follows: 2.040163\*(summed raw scores - 8). Higher scores indicate greater acceptability.
Change in DUTCH Conflict Handling Scores1 month post-baselineThe Dutch Test for Conflict Handling measures aspects of conflict resolution pertaining to the negotiator. The DUTCH measures conflict handling in five domains: avoiding, forcing, yielding, problem solving, and compromising. Each domain is measured independently using panels of four 1-5 likert scale questions each. Domain scores thus range from 5-20, converted to 0-100 with the following formula: 6.25\*(domain score-1). Intra-participant change is measured for each subdomain between baseline and 1 month and generalized to produce mean change per domain. Higher scores per domain indicate more intense conflict handling behavior in the given domain- lower scores indicate less intensity.
Change in Negotiation Knowledge Scores1 months post-baselineWe deployed a panel of 15 questions measuring participant knowledge of negotiation techniques. The panel measures knowledge in three subdomains (identification of interests, rights, and power statements) and can also be measured in aggregate to assess knowledge across the three subdomains. Participants receive 1 point for each correct answer. All Scores, including subdomain scores, are converted to a 0/100 measure. Intraparticipant change is assessed between baseline and 1 month post-intervention. Dependent Sample T-Tests were performed on the change scores from baseline-1 month.
Utilization Rates1 month post-baselineWe deployed a survey panel of 5 yes/no questions to participants asking them about utilization of negotiation techniques in the month following the intervention. Result rates are out of 100%.
Change In Positive and Negative Affect Schedule Scores1 month post-baselineThe Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point verbal frequency scale of 1 (not at all) to 5 (very much). Scores are evaluated out of 50. The ten item scales thus have score ranges from 10-50. Higher scores in a single domain indicate greater perception of that type of affect. So, higher positive affect scores=greater positive affect, and higher negative affect scores=higher negative affect. Positive change on either scale indicates an increase in that domain, and negative change on either scale indicates a decrease in that domain.

Countries

United States

Participant flow

Pre-assignment details

Two participants consented but were not randomized to a condition. One of these participants did not complete baseline intake and was not randomized to a treatment. The other participant did complete baseline intake but did not complete the study phase which assigns participants to a condition (a unique hyperlink which assigns condition and treatment materials when opened- this participant did not open their link).

Participants by arm

ArmCount
Universal Only
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise. All participants will complete this exercise; it will serve as the constant.
15
Older Adult
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Patient \[Advanced\]' ' conflict negotiation/dispute resolution exercise
17
Physician
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
16
Physician/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
16
Sister
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise
17
Sister/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
16
Sister/Physician
(1) 'Caregiver vs. Patient \[Beginner\]' negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise
17
Sister/Physician/OA
(1) 'Caregiver vs. Patient \[Beginner\]' conflict negotiation/dispute resolution exercise; (2) 'Caregiver vs. Caregiver' conflict negotiation/dispute resolution exercise; (3) 'Caregiver vs. Physician' conflict negotiation/dispute resolution exercise; (4) 'Caregiver vs. Patient \[Advanced\]' conflict negotiation/dispute resolution exercise
17
Total131

Baseline characteristics

CharacteristicUniversal OnlyOlder AdultPhysicianPhysician/OASisterSister/OASister/PhysicianSister/Physician/OATotal
Age, Continuous58.33 Years55.71 Years56.81 Years55.56 Years48.76 Years51.44 Years53.23 Years51.59 Years53.64 Years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants4 Participants1 Participants0 Participants2 Participants0 Participants3 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants16 Participants11 Participants14 Participants16 Participants12 Participants15 Participants13 Participants111 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants1 Participants1 Participants1 Participants2 Participants2 Participants1 Participants10 Participants
Positive Affect and Well-Being55.41 T-Score
STANDARD_DEVIATION 4.07
56.22 T-Score
STANDARD_DEVIATION 6.97
55.5 T-Score
STANDARD_DEVIATION 6.84
56.83 T-Score
STANDARD_DEVIATION 7.23
54.2 T-Score
STANDARD_DEVIATION 5.87
52.83 T-Score
STANDARD_DEVIATION 5.66
54.86 T-Score
STANDARD_DEVIATION 4.84
53.9 T-Score
STANDARD_DEVIATION 5.92
54.96 T-Score
STANDARD_DEVIATION 5.98
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants3 Participants1 Participants0 Participants0 Participants0 Participants6 Participants
Race (NIH/OMB)
Black or African American
5 Participants5 Participants5 Participants4 Participants6 Participants3 Participants5 Participants6 Participants39 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants2 Participants0 Participants0 Participants1 Participants2 Participants0 Participants5 Participants
Race (NIH/OMB)
White
9 Participants11 Participants9 Participants9 Participants10 Participants11 Participants10 Participants11 Participants80 Participants
Sex/Gender, Customized
Sex/Gender
Female
12 Participants14 Participants13 Participants12 Participants11 Participants13 Participants15 Participants11 Participants101 Participants
Sex/Gender, Customized
Sex/Gender
Male
3 Participants3 Participants3 Participants4 Participants6 Participants3 Participants2 Participants5 Participants29 Participants
Sex/Gender, Customized
Sex/Gender
Non-Binary
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 170 / 160 / 160 / 170 / 160 / 170 / 17
other
Total, other adverse events
0 / 150 / 170 / 160 / 160 / 170 / 160 / 170 / 17
serious
Total, serious adverse events
0 / 150 / 170 / 160 / 160 / 170 / 160 / 170 / 17

Outcome results

Primary

Change in Neuro-QoL Positive Affect and Well-Being Score

Caregiver well-being as measured by the Positive Affect and Well-being scale for the Neurology Quality of Life (Neuro-QOL). The measure is a 9-item panel rating how caregivers experience feelings of positive affect and well-being. Responses are Likert scales, scored 1-5, Never (1), Rarely (2), Sometimes (3), Often (4), Always (5). Responses are summed for a final score and converted to a t-score per Neuro-QoL manual scoring conventions. Population mean T-Score is 50 and SD is 10. Higher scores indicate higher levels of Positive Affect and Well-Being. Positive change represents an increase in positive affect/well-being, and negative change represents a decrease.

Time frame: Baseline (pre-intervention) and 1 Month Post-intervention

Population: All participants with available data at baseline and 1 month post-intervention assessments were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
Universal OnlyChange in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (Pre-Intervention)55.41 T-ScoreStandard Deviation 4.07
Universal OnlyChange in Neuro-QoL Positive Affect and Well-Being Score1 month Post Intervention54.39 T-ScoreStandard Deviation 5.59
Older AdultChange in Neuro-QoL Positive Affect and Well-Being Score1 month Post Intervention55.74 T-ScoreStandard Deviation 4.82
Older AdultChange in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (Pre-Intervention)56.22 T-ScoreStandard Deviation 6.94
PhysicianChange in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (Pre-Intervention)55.51 T-ScoreStandard Deviation 6.84
PhysicianChange in Neuro-QoL Positive Affect and Well-Being Score1 month Post Intervention53.66 T-ScoreStandard Deviation 6.22
Physician/OAChange in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (Pre-Intervention)56.83 T-ScoreStandard Deviation 7.23
Physician/OAChange in Neuro-QoL Positive Affect and Well-Being Score1 month Post Intervention53.76 T-ScoreStandard Deviation 6.84
SisterChange in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (Pre-Intervention)54.2 T-ScoreStandard Deviation 5.87
SisterChange in Neuro-QoL Positive Affect and Well-Being Score1 month Post Intervention54.51 T-ScoreStandard Deviation 6.51
Sister/OAChange in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (Pre-Intervention)52.83 T-ScoreStandard Deviation 5.66
Sister/OAChange in Neuro-QoL Positive Affect and Well-Being Score1 month Post Intervention53.01 T-ScoreStandard Deviation 5.19
Sister/PhysicianChange in Neuro-QoL Positive Affect and Well-Being Score1 month Post Intervention54.69 T-ScoreStandard Deviation 4.86
Sister/PhysicianChange in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (Pre-Intervention)54.86 T-ScoreStandard Deviation 4.84
Sister/Physician/OAChange in Neuro-QoL Positive Affect and Well-Being Score1 month Post Intervention54.45 T-ScoreStandard Deviation 5.28
Sister/Physician/OAChange in Neuro-QoL Positive Affect and Well-Being ScoreBaseline (Pre-Intervention)53.9 T-ScoreStandard Deviation 5.92
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician treatment arm.p-value: 0.769595% CI: [-0.856, 1.15]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm.p-value: 0.087895% CI: [-1.88, 0.13]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/physician treatment arm.p-value: 0.63595% CI: [-0.76, 1.25]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the older adult treatment arm.p-value: 0.89795% CI: [-1.0709, 0.9394]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician/older adult treatment arm.p-value: 0.982395% CI: [-1.0164, 0.9939]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm.p-value: 0.333795% CI: [-1.4979, 0.5124]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult/physician treatment arm.p-value: 0.69495% CI: [-0.8049, 1.2054]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the intercept (all tx=0).p-value: <0.000195% CI: [53.9003, 55.9109]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This test evaluates the effect of time (measured as weeks since baseline).p-value: 0.115295% CI: [-0.1254, 0.01383]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician treatment arm\*time.p-value: 0.355595% CI: [-0.1022, 0.03699]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm\*time.p-value: 0.054695% CI: [-0.00136, 0.1379]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Physician treatment arm\*time.p-value: 0.461695% CI: [-0.04364, 0.09557]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Older Adult treatment arm\*time.p-value: 0.159295% CI: [-0.0198, 0.1194]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician/Older Adult treatment arm\*time.p-value: 0.489995% CI: [-0.09396, 0.04526]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm\*time.p-value: 0.984295% CI: [-0.06891, 0.0703]Mixed Models Analysis
Comparison: Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Older Adult/Physician treatment arm\*time.p-value: 0.721795% CI: [-0.08216, 0.05705]Mixed Models Analysis
Secondary

Change in Neuro-QoL Caregiver Specific Anxiety Score

TBI-CareQOL is a set of self-report measures within the Neuro-QoL™ measurement system that assesses the health-related quality of life (HRQOL) of caregivers of adults with traumatic brain injury (TBI). Among these is the Caregiver specific anxiety measure. This is a six item likert panel with responses rated 1=never and 5=always, for a combined score range of 6-30. Higher scores indicate greater levels of anxiety. Raw scores were rescaled per the Neuro-QoL scoring manual into T-Scores with a mean of 50 and an SD of 10. Difference between T-score at baseline and 1-month was computed for each participant to produce a change score, and these change scores are averaged to produce per condition means.

Time frame: 1 month post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Universal OnlyChange in Neuro-QoL Caregiver Specific Anxiety Score-.31 change in T-ScoreStandard Deviation 4.12
Older AdultChange in Neuro-QoL Caregiver Specific Anxiety Score-2.21 change in T-ScoreStandard Deviation 7.09
PhysicianChange in Neuro-QoL Caregiver Specific Anxiety Score-2.48 change in T-ScoreStandard Deviation 6.36
Physician/OAChange in Neuro-QoL Caregiver Specific Anxiety Score.27 change in T-ScoreStandard Deviation 7.71
SisterChange in Neuro-QoL Caregiver Specific Anxiety Score-.37 change in T-ScoreStandard Deviation 7.17
Sister/OAChange in Neuro-QoL Caregiver Specific Anxiety Score.58 change in T-ScoreStandard Deviation 6.69
Sister/PhysicianChange in Neuro-QoL Caregiver Specific Anxiety Score-.39 change in T-ScoreStandard Deviation 4.33
Sister/Physician/OAChange in Neuro-QoL Caregiver Specific Anxiety Score-1.4 change in T-ScoreStandard Deviation 5.63
Comparison: Univariate ANOVA on change in T-score between baseline and one month post-intervention. Test is a two-sided paired t-test.p-value: 0.169495% CI: [-0.33, 1.85]two-sided paired T-Test
Secondary

Change in PROMIS Anxiety Score

The PROMIS Adult Emotional Distress-Anxiety scale measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), and hyper-arousal (tension, nervousness, restlessness) in respondents during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). We deployed the four item short form, with scores ranging from 4-20, with higher scores indicating greater severity of anxiety. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.

Time frame: 1 months post-baseline

Population: All participants who were randomized and completed the 1 month post-intervention assessment are included in the change analysis (n=125).

ArmMeasureValue (MEAN)Dispersion
Universal OnlyChange in PROMIS Anxiety Score.52 Change in T-ScoreStandard Deviation 5.43
Older AdultChange in PROMIS Anxiety Score-1.81 Change in T-ScoreStandard Deviation 7.43
PhysicianChange in PROMIS Anxiety Score-.81 Change in T-ScoreStandard Deviation 8.11
Physician/OAChange in PROMIS Anxiety Score-.04 Change in T-ScoreStandard Deviation 6.87
SisterChange in PROMIS Anxiety Score-1.06 Change in T-ScoreStandard Deviation 4.88
Sister/OAChange in PROMIS Anxiety Score-.52 Change in T-ScoreStandard Deviation 4.37
Sister/PhysicianChange in PROMIS Anxiety Score1.74 Change in T-ScoreStandard Deviation 5.09
Sister/Physician/OAChange in PROMIS Anxiety Score-4.11 Change in T-ScoreStandard Deviation 8.8
Comparison: Univariate ANOVA- analytic variable is change in PROMIS Anxiety score from baseline to T3. Test is a paired T-Test.p-value: 0.2195% CI: [-1.9, 0.42]2-sided paired t-Test
Secondary

Change in PROMIS Fatigue Score

The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. We deployed PROMIS Fatigue Form 7a, a seven item likert scale panel ranging from 1=never to 5=always. Scores range from 7-35. Higher scores indicate more fatigue. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. We calculate change in T-Score from baseline to one month per participant and take the mean of those observations to produce mean change in T-score by condition.

Time frame: 1 month post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Universal OnlyChange in PROMIS Fatigue Score-2.58 Change in T-ScoreStandard Error 6.29
Older AdultChange in PROMIS Fatigue Score-2.9 Change in T-ScoreStandard Error 8.86
PhysicianChange in PROMIS Fatigue Score-.36 Change in T-ScoreStandard Error 7.43
Physician/OAChange in PROMIS Fatigue Score.08 Change in T-ScoreStandard Error 5.22
SisterChange in PROMIS Fatigue Score-4.12 Change in T-ScoreStandard Error 5.88
Sister/OAChange in PROMIS Fatigue Score3.33 Change in T-ScoreStandard Error 9.9
Sister/PhysicianChange in PROMIS Fatigue Score1.36 Change in T-ScoreStandard Error 5.97
Sister/Physician/OAChange in PROMIS Fatigue Score-4.26 Change in T-ScoreStandard Error 11.72
Comparison: Univariate ANOVA- analytic variable is change in PROMIS Fatigue score from baseline to T3. Test is a paired T-Test.p-value: 0.195% CI: [-2.62, 0.25]2-Sided Paired T Test
Secondary

Change in PROMIS Satisfaction With Social Roles/Activities Score

The PROMIS adult Satisfaction with Social Roles and Activities item bank assesses satisfaction with performing one's usual social roles and activities (e.g., I am satisfied with my ability to participate in family activities). Short form 8a is deployed here. This is an 8 item likert scale panel, with responses rated 1=never and 5=always. Scores range from 8 to 40. Higher scores indicate greater satisfaction with social roles and activities. The raw score is rescaled per the PROMIS scoring manual into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.

Time frame: 1 months post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Universal OnlyChange in PROMIS Satisfaction With Social Roles/Activities Score.9 Change in T ScoreStandard Deviation 4.7
Older AdultChange in PROMIS Satisfaction With Social Roles/Activities Score2.17 Change in T ScoreStandard Deviation 5.58
PhysicianChange in PROMIS Satisfaction With Social Roles/Activities Score.49 Change in T ScoreStandard Deviation 5.55
Physician/OAChange in PROMIS Satisfaction With Social Roles/Activities Score-1.45 Change in T ScoreStandard Deviation 5.29
SisterChange in PROMIS Satisfaction With Social Roles/Activities Score-.09 Change in T ScoreStandard Deviation 4.42
Sister/OAChange in PROMIS Satisfaction With Social Roles/Activities Score-.92 Change in T ScoreStandard Deviation 5.51
Sister/PhysicianChange in PROMIS Satisfaction With Social Roles/Activities Score-.55 Change in T ScoreStandard Deviation 2.82
Sister/Physician/OAChange in PROMIS Satisfaction With Social Roles/Activities Score.79 Change in T ScoreStandard Deviation 5.26
Comparison: Univariate ANOVA on change in T-Score between baseline and 1 month post-intervention. Test is a 2-sided paired t-test.p-value: 0.7795% CI: [-0.74, 1]2-sided Paired T-Test
Secondary

Change in PROMIS Short Form General Self Efficacy T Score

the PROMIS General Self-Efficacy - Short Form is a four item panel which measures confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. The four items are 1-5 Likert scales, 1=never, 5=always. Minimum score is a 4 and maximum is a 20. Raw Scores are converted to T scores with mean 50 and SD 10 per the PROMIS scoring manual. Higher score=greater self efficacy.

Time frame: 1 months post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Universal OnlyChange in PROMIS Short Form General Self Efficacy T Score-.57 change in T-ScoreStandard Deviation 5.24
Older AdultChange in PROMIS Short Form General Self Efficacy T Score1.22 change in T-ScoreStandard Deviation 11.63
PhysicianChange in PROMIS Short Form General Self Efficacy T Score.55 change in T-ScoreStandard Deviation 8.29
Physician/OAChange in PROMIS Short Form General Self Efficacy T Score-1.32 change in T-ScoreStandard Deviation 6.13
SisterChange in PROMIS Short Form General Self Efficacy T Score.68 change in T-ScoreStandard Deviation 10.14
Sister/OAChange in PROMIS Short Form General Self Efficacy T Score.06 change in T-ScoreStandard Deviation 7.57
Sister/PhysicianChange in PROMIS Short Form General Self Efficacy T Score-2.14 change in T-ScoreStandard Deviation 5
Sister/Physician/OAChange in PROMIS Short Form General Self Efficacy T Score1.59 change in T-ScoreStandard Deviation 7.74
Comparison: Univariate ANOVA on change in PROMIS short form General Self Efficacy T-Score, baseline to one month post-intervention. Test is a 2-sided paired (dependent sample) t-test.p-value: 0.975495% CI: [-1.36, 1.41]2-sided paired (dependent sample) t-test
Secondary

Change in Zarit Caregiver Burden Score

The Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire (Zarit, Reever & Bach-Peterson, 1980). The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). The total score range is 0 to 88. Increasing scores indicate increasing burden. Scores were measured at baseline and at 1 month post-intervention and a change score was computed for each participant. These change scores are averaged to produce the by-condition mean change in burden score. Positive results indicate an increase in burden, and negative results indicate a decrease in burden.

Time frame: 1 month post-baseline

Population: All participants with data available at 1 months post baseline were included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Universal OnlyChange in Zarit Caregiver Burden Score-.07 Change in Burden ScoreStandard Deviation 7.69
Older AdultChange in Zarit Caregiver Burden Score-3.21 Change in Burden ScoreStandard Deviation 11.22
PhysicianChange in Zarit Caregiver Burden Score-9.6 Change in Burden ScoreStandard Deviation 12.05
Physician/OAChange in Zarit Caregiver Burden Score-.44 Change in Burden ScoreStandard Deviation 12.62
SisterChange in Zarit Caregiver Burden Score-3.35 Change in Burden ScoreStandard Deviation 7.93
Sister/OAChange in Zarit Caregiver Burden Score0 Change in Burden ScoreStandard Deviation 14.35
Sister/PhysicianChange in Zarit Caregiver Burden Score-2.59 Change in Burden ScoreStandard Deviation 8.45
Sister/Physician/OAChange in Zarit Caregiver Burden Score-6.69 Change in Burden ScoreStandard Deviation 14.97
Comparison: Univariate ANOVA on change in Zarit Caregiver Burden Score, Baseline to 1-month post-intervention. Test was a 2-sided dependent samples t-test.p-value: 0.002195% CI: [-5.28, -1.2]2-sided dependent sample t-test
Secondary

PROMIS Short Form Emotional Support T Score at Baseline

PROMIS Emotional Support - Short Form. The PROMIS Emotional Support item bank assesses perceived feelings of being cared for and valued as a person; having confident relationships. The short form 6a deployed here is a 6 item likert scale panel, which assesses responses as 1=never and 5=always in response to item statements. Minimum score is a 6 and maximum is a 30. Higher scores indicate greater feelings of emotional support. The raw score is rescaled per the PROMIS scoring manual into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.

Time frame: Baseline Measure

Population: All individuals who received and completed the baseline assessment are included in the analysis population (N=131).

ArmMeasureValue (MEAN)Dispersion
Universal OnlyPROMIS Short Form Emotional Support T Score at Baseline50.42 T-ScoreStandard Deviation 9.28
Older AdultPROMIS Short Form Emotional Support T Score at Baseline54.93 T-ScoreStandard Deviation 9.35
PhysicianPROMIS Short Form Emotional Support T Score at Baseline52.23 T-ScoreStandard Deviation 9.77
Physician/OAPROMIS Short Form Emotional Support T Score at Baseline52.00 T-ScoreStandard Deviation 9.44
SisterPROMIS Short Form Emotional Support T Score at Baseline52.26 T-ScoreStandard Deviation 10.19
Sister/OAPROMIS Short Form Emotional Support T Score at Baseline51.68 T-ScoreStandard Deviation 9.37
Sister/PhysicianPROMIS Short Form Emotional Support T Score at Baseline52.38 T-ScoreStandard Deviation 6.62
Sister/Physician/OAPROMIS Short Form Emotional Support T Score at Baseline50.58 T-ScoreStandard Deviation 8.03
Other Pre-specified

Change in DUTCH Conflict Handling Scores

The Dutch Test for Conflict Handling measures aspects of conflict resolution pertaining to the negotiator. The DUTCH measures conflict handling in five domains: avoiding, forcing, yielding, problem solving, and compromising. Each domain is measured independently using panels of four 1-5 likert scale questions each. Domain scores thus range from 5-20, converted to 0-100 with the following formula: 6.25\*(domain score-1). Intra-participant change is measured for each subdomain between baseline and 1 month and generalized to produce mean change per domain. Higher scores per domain indicate more intense conflict handling behavior in the given domain- lower scores indicate less intensity.

Time frame: 1 month post-baseline

Population: All 125 participants who completed both the baseline and 1-month post-intervention assessments are included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Universal OnlyChange in DUTCH Conflict Handling ScoresChange in Yielding Score-5.42 Change in Domain Score (out of 100)Standard Deviation 13.12
Universal OnlyChange in DUTCH Conflict Handling ScoresChange in Problem Solving Score-2.08 Change in Domain Score (out of 100)Standard Deviation 13.08
Universal OnlyChange in DUTCH Conflict Handling ScoresChange in Avoiding Score11.25 Change in Domain Score (out of 100)Standard Deviation 19.51
Universal OnlyChange in DUTCH Conflict Handling ScoresChange in Forcing Score-7.5 Change in Domain Score (out of 100)Standard Deviation 13.19
Universal OnlyChange in DUTCH Conflict Handling ScoresChange in Compromising Score2.08 Change in Domain Score (out of 100)Standard Deviation 13.71
Older AdultChange in DUTCH Conflict Handling ScoresChange in Avoiding Score.89 Change in Domain Score (out of 100)Standard Deviation 15.08
Older AdultChange in DUTCH Conflict Handling ScoresChange in Problem Solving Score8.48 Change in Domain Score (out of 100)Standard Deviation 13.56
Older AdultChange in DUTCH Conflict Handling ScoresChange in Forcing Score-9.38 Change in Domain Score (out of 100)Standard Deviation 14.66
Older AdultChange in DUTCH Conflict Handling ScoresChange in Compromising Score6.25 Change in Domain Score (out of 100)Standard Deviation 17.68
Older AdultChange in DUTCH Conflict Handling ScoresChange in Yielding Score-1.79 Change in Domain Score (out of 100)Standard Deviation 13.74
PhysicianChange in DUTCH Conflict Handling ScoresChange in Compromising Score2.92 Change in Domain Score (out of 100)Standard Deviation 16.17
PhysicianChange in DUTCH Conflict Handling ScoresChange in Forcing Score-2.5 Change in Domain Score (out of 100)Standard Deviation 18.57
PhysicianChange in DUTCH Conflict Handling ScoresChange in Yielding Score-3.33 Change in Domain Score (out of 100)Standard Deviation 14.54
PhysicianChange in DUTCH Conflict Handling ScoresChange in Problem Solving Score-6.67 Change in Domain Score (out of 100)Standard Deviation 17.43
PhysicianChange in DUTCH Conflict Handling ScoresChange in Avoiding Score-1.25 Change in Domain Score (out of 100)Standard Deviation 17.55
Physician/OAChange in DUTCH Conflict Handling ScoresChange in Problem Solving Score0 Change in Domain Score (out of 100)Standard Deviation 16.93
Physician/OAChange in DUTCH Conflict Handling ScoresChange in Compromising Score3.52 Change in Domain Score (out of 100)Standard Deviation 18.25
Physician/OAChange in DUTCH Conflict Handling ScoresChange in Forcing Score-18.36 Change in Domain Score (out of 100)Standard Deviation 28.09
Physician/OAChange in DUTCH Conflict Handling ScoresChange in Yielding Score-1.95 Change in Domain Score (out of 100)Standard Deviation 10.88
Physician/OAChange in DUTCH Conflict Handling ScoresChange in Avoiding Score-9.38 Change in Domain Score (out of 100)Standard Deviation 13.31
SisterChange in DUTCH Conflict Handling ScoresChange in Yielding Score3.68 Change in Domain Score (out of 100)Standard Deviation 11.49
SisterChange in DUTCH Conflict Handling ScoresChange in Avoiding Score-.37 Change in Domain Score (out of 100)Standard Deviation 13.34
SisterChange in DUTCH Conflict Handling ScoresChange in Compromising Score3.31 Change in Domain Score (out of 100)Standard Deviation 13.82
SisterChange in DUTCH Conflict Handling ScoresChange in Forcing Score-3.68 Change in Domain Score (out of 100)Standard Deviation 15.63
SisterChange in DUTCH Conflict Handling ScoresChange in Problem Solving Score4.04 Change in Domain Score (out of 100)Standard Deviation 17.25
Sister/OAChange in DUTCH Conflict Handling ScoresChange in Forcing Score-9.17 Change in Domain Score (out of 100)Standard Deviation 14.92
Sister/OAChange in DUTCH Conflict Handling ScoresChange in Avoiding Score-.83 Change in Domain Score (out of 100)Standard Deviation 14.73
Sister/OAChange in DUTCH Conflict Handling ScoresChange in Compromising Score2.08 Change in Domain Score (out of 100)Standard Deviation 19.72
Sister/OAChange in DUTCH Conflict Handling ScoresChange in Problem Solving Score1.67 Change in Domain Score (out of 100)Standard Deviation 14.46
Sister/OAChange in DUTCH Conflict Handling ScoresChange in Yielding Score2.5 Change in Domain Score (out of 100)Standard Deviation 12.9
Sister/PhysicianChange in DUTCH Conflict Handling ScoresChange in Forcing Score-3.31 Change in Domain Score (out of 100)Standard Deviation 14.34
Sister/PhysicianChange in DUTCH Conflict Handling ScoresChange in Problem Solving Score-2.57 Change in Domain Score (out of 100)Standard Deviation 9.13
Sister/PhysicianChange in DUTCH Conflict Handling ScoresChange in Compromising Score-2.94 Change in Domain Score (out of 100)Standard Deviation 12.13
Sister/PhysicianChange in DUTCH Conflict Handling ScoresChange in Avoiding Score-.74 Change in Domain Score (out of 100)Standard Deviation 14.3
Sister/PhysicianChange in DUTCH Conflict Handling ScoresChange in Yielding Score1.1 Change in Domain Score (out of 100)Standard Deviation 11.32
Sister/Physician/OAChange in DUTCH Conflict Handling ScoresChange in Avoiding Score-2.34 Change in Domain Score (out of 100)Standard Deviation 19.48
Sister/Physician/OAChange in DUTCH Conflict Handling ScoresChange in Yielding Score-4.3 Change in Domain Score (out of 100)Standard Deviation 9.87
Sister/Physician/OAChange in DUTCH Conflict Handling ScoresChange in Compromising Score1.56 Change in Domain Score (out of 100)Standard Deviation 20.22
Sister/Physician/OAChange in DUTCH Conflict Handling ScoresChange in Forcing Score-1.56 Change in Domain Score (out of 100)Standard Deviation 23.11
Sister/Physician/OAChange in DUTCH Conflict Handling ScoresChange in Problem Solving Score-4.3 Change in Domain Score (out of 100)Standard Deviation 19.06
Comparison: Univariate ANOVA on change in Avoiding Score (out of 100) between Baseline and 1 Month Post-Intervention.p-value: 0.76ANOVA
Comparison: Univariate ANOVA on change in Compromising Score (out of 100) between Baseline and 1 Month Post-Intervention.p-value: 0.13ANOVA
Comparison: Univariate ANOVA on change in Forcing Score (out of 100) between Baseline and 1 Month Post-Intervention.p-value: <0.0001ANOVA
Comparison: Univariate ANOVA on change in Problem Solving Score (out of 100) between Baseline and 1 Month Post-Intervention.p-value: 0.86ANOVA
Comparison: Univariate ANOVA on change in Yielding Score (out of 100) between Baseline and 1 Month Post-Intervention.p-value: 0.32ANOVA
Other Pre-specified

Change in Negotiation Knowledge Scores

We deployed a panel of 15 questions measuring participant knowledge of negotiation techniques. The panel measures knowledge in three subdomains (identification of interests, rights, and power statements) and can also be measured in aggregate to assess knowledge across the three subdomains. Participants receive 1 point for each correct answer. All Scores, including subdomain scores, are converted to a 0/100 measure. Intraparticipant change is assessed between baseline and 1 month post-intervention. Dependent Sample T-Tests were performed on the change scores from baseline-1 month.

Time frame: 1 months post-baseline

Population: All Participants who completed the 1 month post-intervention assessment are included.

ArmMeasureGroupValue (MEAN)Dispersion
Universal OnlyChange in Negotiation Knowledge ScoresChange in Interests score6.67 Change in Score Baseline-1 MonthStandard Deviation 12.28
Universal OnlyChange in Negotiation Knowledge ScoresChange in Rights Score10.67 Change in Score Baseline-1 MonthStandard Deviation 31.95
Universal OnlyChange in Negotiation Knowledge ScoresChange in total score6.22 Change in Score Baseline-1 MonthStandard Deviation 11.94
Universal OnlyChange in Negotiation Knowledge ScoresChange in Power Score0 Change in Score Baseline-1 MonthStandard Deviation 23.15
Older AdultChange in Negotiation Knowledge ScoresChange in total score-1.9 Change in Score Baseline-1 MonthStandard Deviation 11.23
Older AdultChange in Negotiation Knowledge ScoresChange in Rights Score-4.29 Change in Score Baseline-1 MonthStandard Deviation 19.5
Older AdultChange in Negotiation Knowledge ScoresChange in Interests score1.19 Change in Score Baseline-1 MonthStandard Deviation 10.26
Older AdultChange in Negotiation Knowledge ScoresChange in Power Score-3.57 Change in Score Baseline-1 MonthStandard Deviation 13.36
PhysicianChange in Negotiation Knowledge ScoresChange in Rights Score5.33 Change in Score Baseline-1 MonthStandard Deviation 22
PhysicianChange in Negotiation Knowledge ScoresChange in total score.89 Change in Score Baseline-1 MonthStandard Deviation 19.82
PhysicianChange in Negotiation Knowledge ScoresChange in Interests score-1.11 Change in Score Baseline-1 MonthStandard Deviation 27.79
PhysicianChange in Negotiation Knowledge ScoresChange in Power Score-1.67 Change in Score Baseline-1 MonthStandard Deviation 25.82
Physician/OAChange in Negotiation Knowledge ScoresChange in Rights Score7.5 Change in Score Baseline-1 MonthStandard Deviation 21.76
Physician/OAChange in Negotiation Knowledge ScoresChange in Interests score9.38 Change in Score Baseline-1 MonthStandard Deviation 21.05
Physician/OAChange in Negotiation Knowledge ScoresChange in total score8.33 Change in Score Baseline-1 MonthStandard Deviation 14.91
Physician/OAChange in Negotiation Knowledge ScoresChange in Power Score7.81 Change in Score Baseline-1 MonthStandard Deviation 17.6
SisterChange in Negotiation Knowledge ScoresChange in total score4.71 Change in Score Baseline-1 MonthStandard Deviation 9.65
SisterChange in Negotiation Knowledge ScoresChange in Interests score7.84 Change in Score Baseline-1 MonthStandard Deviation 17.79
SisterChange in Negotiation Knowledge ScoresChange in Rights Score4.71 Change in Score Baseline-1 MonthStandard Deviation 16.63
SisterChange in Negotiation Knowledge ScoresChange in Power Score0 Change in Score Baseline-1 MonthStandard Deviation 17.68
Sister/OAChange in Negotiation Knowledge ScoresChange in Power Score1.67 Change in Score Baseline-1 MonthStandard Deviation 25.82
Sister/OAChange in Negotiation Knowledge ScoresChange in Interests score4.44 Change in Score Baseline-1 MonthStandard Deviation 17.21
Sister/OAChange in Negotiation Knowledge ScoresChange in Rights Score2.67 Change in Score Baseline-1 MonthStandard Deviation 16.68
Sister/OAChange in Negotiation Knowledge ScoresChange in total score3.11 Change in Score Baseline-1 MonthStandard Deviation 12.82
Sister/PhysicianChange in Negotiation Knowledge ScoresChange in Interests score4.9 Change in Score Baseline-1 MonthStandard Deviation 11.43
Sister/PhysicianChange in Negotiation Knowledge ScoresChange in total score2.35 Change in Score Baseline-1 MonthStandard Deviation 13.11
Sister/PhysicianChange in Negotiation Knowledge ScoresChange in Power Score-1.47 Change in Score Baseline-1 MonthStandard Deviation 20.67
Sister/PhysicianChange in Negotiation Knowledge ScoresChange in Rights Score2.35 Change in Score Baseline-1 MonthStandard Deviation 28.18
Sister/Physician/OAChange in Negotiation Knowledge ScoresChange in Interests score5.21 Change in Score Baseline-1 MonthStandard Deviation 15.77
Sister/Physician/OAChange in Negotiation Knowledge ScoresChange in total score.42 Change in Score Baseline-1 MonthStandard Deviation 9.57
Sister/Physician/OAChange in Negotiation Knowledge ScoresChange in Rights Score-3.75 Change in Score Baseline-1 MonthStandard Deviation 18.21
Sister/Physician/OAChange in Negotiation Knowledge ScoresChange in Power Score-1.56 Change in Score Baseline-1 MonthStandard Deviation 11.06
Comparison: Univariate ANOVA on change in total Negotiation Knowledge score, Baseline 1-month. Threshold for significance was alpha=0.05.p-value: 0.0012ANOVA
Comparison: Univariate ANOVA on change in Negotiation Knowledge Interests score, Baseline 1-month. Threshold for significance was alpha=0.05.p-value: 0.0018ANOVA
Comparison: Univariate ANOVA on change in Negotiation Knowledge Power score, Baseline 1-month.p-value: 0.91ANOVA
Comparison: Univariate ANOVA on change in Negotiation Knowledge Rights score, Baseline 1-month.p-value: 0.11ANOVA
Other Pre-specified

Change In Positive and Negative Affect Schedule Scores

The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point verbal frequency scale of 1 (not at all) to 5 (very much). Scores are evaluated out of 50. The ten item scales thus have score ranges from 10-50. Higher scores in a single domain indicate greater perception of that type of affect. So, higher positive affect scores=greater positive affect, and higher negative affect scores=higher negative affect. Positive change on either scale indicates an increase in that domain, and negative change on either scale indicates a decrease in that domain.

Time frame: 1 month post-baseline

Population: All participants with data available at 1 month post-intervention were included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Universal OnlyChange In Positive and Negative Affect Schedule ScoresNegative Affect Score-.2 Change in ScoreStandard Deviation 4.06
Universal OnlyChange In Positive and Negative Affect Schedule ScoresPositive Affect Score-.53 Change in ScoreStandard Deviation 2.7
Older AdultChange In Positive and Negative Affect Schedule ScoresNegative Affect Score-2.21 Change in ScoreStandard Deviation 5.15
Older AdultChange In Positive and Negative Affect Schedule ScoresPositive Affect Score1.21 Change in ScoreStandard Deviation 4.69
PhysicianChange In Positive and Negative Affect Schedule ScoresNegative Affect Score-2.67 Change in ScoreStandard Deviation 5.74
PhysicianChange In Positive and Negative Affect Schedule ScoresPositive Affect Score0 Change in ScoreStandard Deviation 5.15
Physician/OAChange In Positive and Negative Affect Schedule ScoresPositive Affect Score.75 Change in ScoreStandard Deviation 5.72
Physician/OAChange In Positive and Negative Affect Schedule ScoresNegative Affect Score-2.19 Change in ScoreStandard Deviation 7.13
SisterChange In Positive and Negative Affect Schedule ScoresNegative Affect Score-2.12 Change in ScoreStandard Deviation 5.05
SisterChange In Positive and Negative Affect Schedule ScoresPositive Affect Score.76 Change in ScoreStandard Deviation 3.98
Sister/OAChange In Positive and Negative Affect Schedule ScoresPositive Affect Score.2 Change in ScoreStandard Deviation 4.89
Sister/OAChange In Positive and Negative Affect Schedule ScoresNegative Affect Score-1.2 Change in ScoreStandard Deviation 4.75
Sister/PhysicianChange In Positive and Negative Affect Schedule ScoresPositive Affect Score.47 Change in ScoreStandard Deviation 4.35
Sister/PhysicianChange In Positive and Negative Affect Schedule ScoresNegative Affect Score-1.76 Change in ScoreStandard Deviation 6.19
Sister/Physician/OAChange In Positive and Negative Affect Schedule ScoresNegative Affect Score-4.19 Change in ScoreStandard Deviation 7.26
Sister/Physician/OAChange In Positive and Negative Affect Schedule ScoresPositive Affect Score-.13 Change in ScoreStandard Deviation 7.11
Comparison: Univariate ANOVA on change in negative affect score, baseline-1 month post-intervention. Test is a 2 sided dependent sample t-test.p-value: <0.000195% CI: [-3.09, -1.07]2-sided dependent sample t-test
Comparison: Univariate ANOVA of change in positive affect score between baseline-1 month post-intervention. Test is a 2-sided dependent sample t-test.p-value: 0.430595% CI: [-0.52, 1.21]2-sided dependent sample t-test
Other Pre-specified

Exercise Completion Rate

Measuring the feasibility of the intervention by assessing completion of negotiation training exercises.

Time frame: 2 weeks post-baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Universal OnlyExercise Completion Rate15 Participants
Older AdultExercise Completion Rate16 Participants
PhysicianExercise Completion Rate16 Participants
Physician/OAExercise Completion Rate16 Participants
SisterExercise Completion Rate17 Participants
Sister/OAExercise Completion Rate15 Participants
Sister/PhysicianExercise Completion Rate17 Participants
Sister/Physician/OAExercise Completion Rate16 Participants
Other Pre-specified

Participant Retention Rate at 3 Months Post-baseline

Percentage- numerator=# of participants who completed 3 month post-baseline assessment, denominator=# of participants randomized to a condition.

Time frame: 3 months post-baseline

Population: 131 participants were randomized from a total 133 consented- 2 did not complete pre-randomization activities. Here we were interested in the raw number of recruited participants retained regardless of intervention received, thus all participants were considered in the analysis and group segmentation would be inappropriate for the calculation.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Universal OnlyParticipant Retention Rate at 3 Months Post-baseline124 Participants
Other Pre-specified

System Usability Scale Score

Measuring the feasibility of the intervention by measuring the usability of the intervention as measured by the System Usability Scale (SUS), a 10-item measure of usability. SUS is a 10-item likert panel, with scores ranging from 1-5. Scores are tabulated by converting raw scores by subtracting 1 from each raw score and then summing per the scoring manual: summed score=2.5\*(20+(sum of odd numbered questions)-(sum of even number questions)). The minimum and maximum values are thus 50 and 100. Higher scores indicate greater usability.

Time frame: 2 weeks post-intervention

Population: 128 participants of 131 randomized completed the 2 weeks post-intervention assessment.

ArmMeasureValue (MEAN)Dispersion
Universal OnlySystem Usability Scale Score68 score on a scaleStandard Deviation 16
Older AdultSystem Usability Scale Score68 score on a scaleStandard Deviation 16
PhysicianSystem Usability Scale Score68 score on a scaleStandard Deviation 17
Physician/OASystem Usability Scale Score65 score on a scaleStandard Deviation 12
SisterSystem Usability Scale Score73 score on a scaleStandard Deviation 14
Sister/OASystem Usability Scale Score71 score on a scaleStandard Deviation 13
Sister/PhysicianSystem Usability Scale Score63 score on a scaleStandard Deviation 17
Sister/Physician/OASystem Usability Scale Score67 score on a scaleStandard Deviation 19
Other Pre-specified

USE Acceptability Score

The USE Acceptability score measures the acceptability of the intervention, employing an 8-item panel of 1-7 Likert scale questions, with a 0 option for not applicable. Raw score is converted to 0-100 score as follows: 2.040163\*(summed raw scores - 8). Higher scores indicate greater acceptability.

Time frame: 2 weeks post-intervention

Population: 128 of 131 randomized participants completed the post-intervention assessment.

ArmMeasureValue (MEAN)Dispersion
Universal OnlyUSE Acceptability Score78 score on a scaleStandard Deviation 11
Older AdultUSE Acceptability Score73 score on a scaleStandard Deviation 22
PhysicianUSE Acceptability Score74 score on a scaleStandard Deviation 20
Physician/OAUSE Acceptability Score74 score on a scaleStandard Deviation 12
SisterUSE Acceptability Score65 score on a scaleStandard Deviation 23
Sister/OAUSE Acceptability Score80 score on a scaleStandard Deviation 12
Sister/PhysicianUSE Acceptability Score71 score on a scaleStandard Deviation 19
Sister/Physician/OAUSE Acceptability Score70 score on a scaleStandard Deviation 67
Other Pre-specified

Utilization Rates

We deployed a survey panel of 5 yes/no questions to participants asking them about utilization of negotiation techniques in the month following the intervention. Result rates are out of 100%.

Time frame: 1 month post-baseline

Population: 125 participants out of 131 randomized had data available at one month post-intervention. Of those, only 85 were deployed the website utilization question.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Universal OnlyUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?Yes9 Participants
Universal OnlyUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?No8 Participants
Universal OnlyUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?No6 Participants
Universal OnlyUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?No9 Participants
Universal OnlyUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?No6 Participants
Universal OnlyUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?Yes7 Participants
Universal OnlyUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?Yes9 Participants
Universal OnlyUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?Yes6 Participants
Universal OnlyUtilization RatesIn the past month, have you visited NegotiAge.com?No4 Participants
Universal OnlyUtilization RatesIn the past month, have you visited NegotiAge.com?Yes6 Participants
Older AdultUtilization RatesIn the past month, have you visited NegotiAge.com?Yes3 Participants
Older AdultUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?No7 Participants
Older AdultUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?No5 Participants
Older AdultUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?No6 Participants
Older AdultUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?Yes8 Participants
Older AdultUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?Yes8 Participants
Older AdultUtilization RatesIn the past month, have you visited NegotiAge.com?No7 Participants
Older AdultUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?Yes9 Participants
Older AdultUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?Yes7 Participants
Older AdultUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?No6 Participants
PhysicianUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?Yes10 Participants
PhysicianUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?No9 Participants
PhysicianUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?No6 Participants
PhysicianUtilization RatesIn the past month, have you visited NegotiAge.com?No7 Participants
PhysicianUtilization RatesIn the past month, have you visited NegotiAge.com?Yes3 Participants
PhysicianUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?Yes6 Participants
PhysicianUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?No9 Participants
PhysicianUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?Yes9 Participants
PhysicianUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?No5 Participants
PhysicianUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?Yes6 Participants
Physician/OAUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?No6 Participants
Physician/OAUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?Yes8 Participants
Physician/OAUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?No7 Participants
Physician/OAUtilization RatesIn the past month, have you visited NegotiAge.com?No4 Participants
Physician/OAUtilization RatesIn the past month, have you visited NegotiAge.com?Yes7 Participants
Physician/OAUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?Yes10 Participants
Physician/OAUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?No8 Participants
Physician/OAUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?Yes8 Participants
Physician/OAUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?No8 Participants
Physician/OAUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?Yes9 Participants
SisterUtilization RatesIn the past month, have you visited NegotiAge.com?No5 Participants
SisterUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?Yes7 Participants
SisterUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?No10 Participants
SisterUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?Yes6 Participants
SisterUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?No11 Participants
SisterUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?No10 Participants
SisterUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?Yes7 Participants
SisterUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?Yes5 Participants
SisterUtilization RatesIn the past month, have you visited NegotiAge.com?Yes7 Participants
SisterUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?No12 Participants
Sister/OAUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?No8 Participants
Sister/OAUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?No8 Participants
Sister/OAUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?Yes7 Participants
Sister/OAUtilization RatesIn the past month, have you visited NegotiAge.com?Yes4 Participants
Sister/OAUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?No5 Participants
Sister/OAUtilization RatesIn the past month, have you visited NegotiAge.com?No5 Participants
Sister/OAUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?Yes10 Participants
Sister/OAUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?Yes7 Participants
Sister/OAUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?Yes7 Participants
Sister/OAUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?No8 Participants
Sister/PhysicianUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?Yes12 Participants
Sister/PhysicianUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?Yes4 Participants
Sister/PhysicianUtilization RatesIn the past month, have you visited NegotiAge.com?No5 Participants
Sister/PhysicianUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?No13 Participants
Sister/PhysicianUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?Yes9 Participants
Sister/PhysicianUtilization RatesIn the past month, have you visited NegotiAge.com?Yes7 Participants
Sister/PhysicianUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?No13 Participants
Sister/PhysicianUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?No5 Participants
Sister/PhysicianUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?No8 Participants
Sister/PhysicianUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?Yes4 Participants
Sister/Physician/OAUtilization RatesIn the past month, have you visited NegotiAge.com?No4 Participants
Sister/Physician/OAUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?No7 Participants
Sister/Physician/OAUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?Yes7 Participants
Sister/Physician/OAUtilization RatesIn the past month, have you experienced any conflicts related to the care of your older adult?Yes9 Participants
Sister/Physician/OAUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?Yes3 Participants
Sister/Physician/OAUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?Yes3 Participants
Sister/Physician/OAUtilization RatesAre there other parts of your life where you used negotiation skills gained during this study?No13 Participants
Sister/Physician/OAUtilization RatesIn the past month, have you used anything you learned from the negotiation training activities?No13 Participants
Sister/Physician/OAUtilization RatesIn the past month, have you negotiated anything related to the care of your older adult?No9 Participants
Sister/Physician/OAUtilization RatesIn the past month, have you visited NegotiAge.com?Yes7 Participants

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026