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Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project

Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03036189
Enrollment
211
Registered
2017-01-30
Start date
2017-09-15
Completion date
2020-01-29
Last updated
2023-06-28

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

Conditions

Chronic Disease

Brief summary

This is a group randomized trial of an intervention to improve chronic illness self-management.

Interventions

BEHAVIORALbaa nnilah

7 meetings in the community led by a trained community facilitator

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Nevada, Las Vegas
CollaboratorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Montana State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

delayed control group design

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 25 years * AI * diagnosed with diabetes * hypertension * osteoporosis * liver disease * chronic lung disease (asthma, chronic bronchitis or emphysema) * heart disease (coronary artery disease or congestive heart failure) * stroke (completed cerebrovascular accident with neurologic handicap and normal mentation) * chronic arthritis

Exclusion criteria

* major medical illness that precludes their attendance at 7 meetings * \<25 years of age

Design outcomes

Primary

MeasureTime frameDescription
SF-12 - Physical HealthIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)The SF-12 is a set of 12 questions regarding function in physical and mental health domains. We changed question 2 to encapsulate moderate activities more applicable to our study population. Activities deleted were bowling and playing golf and activities added were carrying a small child, walking for exercise, or round dancing/push dancing (Native American traditional dances). Participants responded to questions about their physical and mental health, especially regarding the degree of limitation experienced, using varying response categories (i.e., 3, 5, or 6-point Likert scale, or yes/no format). A Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score were computed and normalized based on an algorithm developed by Farivar, Cunningham, and Hays (2007), which used an oblique factor solution for item weights. PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.
SF-12 - Mental HealthIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)The SF-12 is a set of 12 questions regarding function in physical and mental health domains. We changed question 2 to encapsulate moderate activities more applicable to our study population. Activities deleted were bowling and playing golf and activities added were carrying a small child, walking for exercise, or round dancing/push dancing (Native American traditional dances). Participants responded to questions about their physical and mental health, especially regarding the degree of limitation experienced, using varying response categories (i.e., 3, 5, or 6-point Likert scale, or yes/no format). A Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score were computed and normalized based on an algorithm developed by Farivar, Cunningham, and Hays (2007), which used an oblique factor solution for item weights. PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.

Secondary

MeasureTime frameDescription
PROMIS Self-Efficacy for Managing SymptomsIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the participant's confidence in their ability to manage symptoms of chronic illness and prevent them from interfering from activities of daily living, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.
PROMIS Emotional SupportIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's perception of availability of trusted individuals in their life to provide emotional support, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.
PROMIS Positive Affect and Well-beingIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's recent sense of well-being and agreement with positive outlook and experience of life, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.
PROMIS Physical FunctionIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the function of upper/lower extremities, core, and ability to perform activities of daily living, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.
PROMIS Self-efficacy for Managing EmotionsIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the participant's current confidence to manage emotional distress and stressful situations core, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.
Patient Health Questionnaire-9Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)The PHQ-9 is a widely used instrument to measure symptoms of depression. This set of 9 questions asked participants to respond to statements pertaining to their mental health in the preceding 2 weeks. The score range for the instrument is 0-27, with higher scores correlating with higher levels of symptoms of depression. Additionally, there is 1 question, not scored, rating difficulty of problems.
Patient Activation MeasureIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)PAM assesses self-management related health knowledge, skills, and confidence. Developed by Insignia Health as a 22-item measure and shortened to 13 questions, with the short form validated to assess patient knowledge, skill and confidence for self-management of health conditions. We used the 13-item measure. Insignia Health's proprietary survey scoring algorithm produces a PAM Score along an empirical, interval-level scale from 0-100 with higher scores indicating higher patient activation.
Modified Timed Up and GoIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)The TUG test is physical test that assists in screening and measurement of balance deficits in older adults, which correlates with increased fall risk, and has been validated across populations. In this physical test, participants sit in a chair with feet flat on the ground and back against the chair. A timer is started as they leave the chair, and continues as they pace 3 meters, execute a 180 degree turn and just as they touch the chair again, the timer is stopped. Due to an error in communication between a consultant who assisted with this measure and the research team, the distance that individuals walked during this test was modified from 3 m to 10 m, therefore prior validation data may not apply.
Modified Balance Error Scoring SystemIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)The original Balance Error Scoring System (BESS) involved firm and padded surface balance testing in 3 positions, to assess static balance and was validated across study populations. The mBESS only utilizes firm surface data and demonstrated better intertester reliability and validity. During this physical test, a staff member counts how many times participants help themselves to regain balance in 20 seconds. The mBESS involved 3 positions, depicted below. Participants stood with hands on hips and eyes closed, balancing for 20 s in 3 standing positions: a double-leg stance, a single-leg stance, and tandem stance. Test observers counted up to 10 errors per stance, including opening eyes, taking hands off hips, stepping, putting a hand out to a chair or wall, or making other large corrections, which led to a stance score ranging from 0 to 10 with a maximum total of 30. Participants who could not complete a position for balance reasons, were given a score of 10.
6-minute WalkIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)Serves as a corollary for physical function and cardiovascular performance.Participants walked at a comfortable pace for six minutes and their distance was recorded in feet.
PROMIS Self-efficacy for Managing Social InteractionsIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)Patient Reported Outcome Measurement Information System (PROMIS) measure. This 4 item form was used to assess the participant's current confidence in being able to access support in processing emotions and health problems, and obtain assistance with transportation and problem solving, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.
PROMIS Satisfaction With Social Roles and ActivitiesIntervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's satisfaction with and ability to participant in social roles and activities, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Arm
There are no devices or drugs used in this trial. The treatment is the same for the intervention arm and the wait-list control arm. The treatment is group trial of 7 meetings designed to improve chronic illness self-management. The name of the treatment is baa nnilah. baa nnilah: 7 meetings in the community led by a trained community facilitator
104
Wait-list Control Arm
There are no devices or drugs used in this trial. The treatment is the same for the intervention arm and the wait-list control arm. The treatment is group trial of 7 meetings designed to improve chronic illness self-management. The name of the treatment is baa nnilah. baa nnilah: 7 meetings in the community led by a trained community facilitator
107
Total211

Baseline characteristics

CharacteristicWait-list Control ArmTotalIntervention Arm
Age, Continuous52.46 years
STANDARD_DEVIATION 14.36
52.09 years
STANDARD_DEVIATION 13.47
51.71 years
STANDARD_DEVIATION 13.47
Race (NIH/OMB)
American Indian or Alaska Native
107 Participants211 Participants104 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
83 Participants152 Participants69 Participants
Sex: Female, Male
Male
24 Participants59 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 1041 / 107
other
Total, other adverse events
0 / 1040 / 107
serious
Total, serious adverse events
0 / 1040 / 107

Outcome results

Primary

SF-12 - Mental Health

The SF-12 is a set of 12 questions regarding function in physical and mental health domains. We changed question 2 to encapsulate moderate activities more applicable to our study population. Activities deleted were bowling and playing golf and activities added were carrying a small child, walking for exercise, or round dancing/push dancing (Native American traditional dances). Participants responded to questions about their physical and mental health, especially regarding the degree of limitation experienced, using varying response categories (i.e., 3, 5, or 6-point Likert scale, or yes/no format). A Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score were computed and normalized based on an algorithm developed by Farivar, Cunningham, and Hays (2007), which used an oblique factor solution for item weights. PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmSF-12 - Mental HealthT143.85 units on a scaleStandard Deviation 11.18
Intervention ArmSF-12 - Mental HealthT245.65 units on a scaleStandard Deviation 10.86
Intervention ArmSF-12 - Mental HealthT345.56 units on a scaleStandard Deviation 11.04
Intervention ArmSF-12 - Mental HealthT445.33 units on a scaleStandard Deviation 10.52
Wait-list Control ArmSF-12 - Mental HealthT445.26 units on a scaleStandard Deviation 9.63
Wait-list Control ArmSF-12 - Mental HealthT344.50 units on a scaleStandard Deviation 10.03
Wait-list Control ArmSF-12 - Mental HealthT143.64 units on a scaleStandard Deviation 9.97
Wait-list Control ArmSF-12 - Mental HealthT549.30 units on a scaleStandard Deviation 10.1
Wait-list Control ArmSF-12 - Mental HealthT245.18 units on a scaleStandard Deviation 9.44
p-value: 0.71Mixed Models Analysis
Primary

SF-12 - Physical Health

The SF-12 is a set of 12 questions regarding function in physical and mental health domains. We changed question 2 to encapsulate moderate activities more applicable to our study population. Activities deleted were bowling and playing golf and activities added were carrying a small child, walking for exercise, or round dancing/push dancing (Native American traditional dances). Participants responded to questions about their physical and mental health, especially regarding the degree of limitation experienced, using varying response categories (i.e., 3, 5, or 6-point Likert scale, or yes/no format). A Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score were computed and normalized based on an algorithm developed by Farivar, Cunningham, and Hays (2007), which used an oblique factor solution for item weights. PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmSF-12 - Physical HealthT143.85 score on a scaleStandard Deviation 11.18
Intervention ArmSF-12 - Physical HealthT245.65 score on a scaleStandard Deviation 10.86
Intervention ArmSF-12 - Physical HealthT345.56 score on a scaleStandard Deviation 11.04
Intervention ArmSF-12 - Physical HealthT445.33 score on a scaleStandard Deviation 10.53
Wait-list Control ArmSF-12 - Physical HealthT445.26 score on a scaleStandard Deviation 9.63
Wait-list Control ArmSF-12 - Physical HealthT344.50 score on a scaleStandard Deviation 10.03
Wait-list Control ArmSF-12 - Physical HealthT143.64 score on a scaleStandard Deviation 9.97
Wait-list Control ArmSF-12 - Physical HealthT547.13 score on a scaleStandard Deviation 9.51
Wait-list Control ArmSF-12 - Physical HealthT245.18 score on a scaleStandard Deviation 9.42
p-value: 0.5Mixed Models Analysis
Secondary

6-minute Walk

Serves as a corollary for physical function and cardiovascular performance.Participants walked at a comfortable pace for six minutes and their distance was recorded in feet.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Arm6-minute WalkT11260.23 feetStandard Deviation 287.7
Intervention Arm6-minute WalkT21336.75 feetStandard Deviation 273.48
Intervention Arm6-minute WalkT31060.11 feetStandard Deviation 603.53
Intervention Arm6-minute WalkT41312.84 feetStandard Deviation 379.76
Wait-list Control Arm6-minute WalkT41334.98 feetStandard Deviation 284.74
Wait-list Control Arm6-minute WalkT31283.54 feetStandard Deviation 449.1
Wait-list Control Arm6-minute WalkT11298.85 feetStandard Deviation 265.4
Wait-list Control Arm6-minute WalkT51287.08 feetStandard Deviation 320.25
Wait-list Control Arm6-minute WalkT21358.96 feetStandard Deviation 323.35
p-value: 0.64Mixed Models Analysis
Secondary

Modified Balance Error Scoring System

The original Balance Error Scoring System (BESS) involved firm and padded surface balance testing in 3 positions, to assess static balance and was validated across study populations. The mBESS only utilizes firm surface data and demonstrated better intertester reliability and validity. During this physical test, a staff member counts how many times participants help themselves to regain balance in 20 seconds. The mBESS involved 3 positions, depicted below. Participants stood with hands on hips and eyes closed, balancing for 20 s in 3 standing positions: a double-leg stance, a single-leg stance, and tandem stance. Test observers counted up to 10 errors per stance, including opening eyes, taking hands off hips, stepping, putting a hand out to a chair or wall, or making other large corrections, which led to a stance score ranging from 0 to 10 with a maximum total of 30. Participants who could not complete a position for balance reasons, were given a score of 10.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmModified Balance Error Scoring SystemT214.17 total number of errors over three trialsStandard Deviation 7.22
Intervention ArmModified Balance Error Scoring SystemT113.41 total number of errors over three trialsStandard Deviation 6.33
Intervention ArmModified Balance Error Scoring SystemT315.30 total number of errors over three trialsStandard Deviation 10.26
Intervention ArmModified Balance Error Scoring SystemT420.96 total number of errors over three trialsStandard Deviation 8.87
Wait-list Control ArmModified Balance Error Scoring SystemT421.03 total number of errors over three trialsStandard Deviation 9.44
Wait-list Control ArmModified Balance Error Scoring SystemT311.91 total number of errors over three trialsStandard Deviation 10.57
Wait-list Control ArmModified Balance Error Scoring SystemT513.38 total number of errors over three trialsStandard Deviation 6.94
Wait-list Control ArmModified Balance Error Scoring SystemT113.81 total number of errors over three trialsStandard Deviation 6.6
Wait-list Control ArmModified Balance Error Scoring SystemT212.68 total number of errors over three trialsStandard Deviation 6.59
p-value: 0.84Mixed Models Analysis
Secondary

Modified Timed Up and Go

The TUG test is physical test that assists in screening and measurement of balance deficits in older adults, which correlates with increased fall risk, and has been validated across populations. In this physical test, participants sit in a chair with feet flat on the ground and back against the chair. A timer is started as they leave the chair, and continues as they pace 3 meters, execute a 180 degree turn and just as they touch the chair again, the timer is stopped. Due to an error in communication between a consultant who assisted with this measure and the research team, the distance that individuals walked during this test was modified from 3 m to 10 m, therefore prior validation data may not apply.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmModified Timed Up and GoT219.26 secondsStandard Deviation 5.08
Intervention ArmModified Timed Up and GoT418.42 secondsStandard Deviation 4.27
Intervention ArmModified Timed Up and GoT120.83 secondsStandard Deviation 5.43
Intervention ArmModified Timed Up and GoT317.18 secondsStandard Deviation 5.51
Wait-list Control ArmModified Timed Up and GoT120.39 secondsStandard Deviation 5.3
Wait-list Control ArmModified Timed Up and GoT519.06 secondsStandard Deviation 4.58
Wait-list Control ArmModified Timed Up and GoT219.34 secondsStandard Deviation 4.31
Wait-list Control ArmModified Timed Up and GoT318.70 secondsStandard Deviation 7.3
Wait-list Control ArmModified Timed Up and GoT418.26 secondsStandard Deviation 3.79
p-value: 0.07Mixed Models Analysis
Secondary

Patient Activation Measure

PAM assesses self-management related health knowledge, skills, and confidence. Developed by Insignia Health as a 22-item measure and shortened to 13 questions, with the short form validated to assess patient knowledge, skill and confidence for self-management of health conditions. We used the 13-item measure. Insignia Health's proprietary survey scoring algorithm produces a PAM Score along an empirical, interval-level scale from 0-100 with higher scores indicating higher patient activation.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPatient Activation MeasureT169.31 units on a scaleStandard Deviation 17.73
Intervention ArmPatient Activation MeasureT368.47 units on a scaleStandard Deviation 20.88
Intervention ArmPatient Activation MeasureT267.53 units on a scaleStandard Deviation 21.22
Intervention ArmPatient Activation MeasureT467.05 units on a scaleStandard Deviation 17.91
Wait-list Control ArmPatient Activation MeasureT270.61 units on a scaleStandard Deviation 19.66
Wait-list Control ArmPatient Activation MeasureT165.50 units on a scaleStandard Deviation 16.41
Wait-list Control ArmPatient Activation MeasureT471.57 units on a scaleStandard Deviation 18.59
Wait-list Control ArmPatient Activation MeasureT371.67 units on a scaleStandard Deviation 17.97
p-value: 0.4Mixed Models Analysis
Secondary

Patient Health Questionnaire-9

The PHQ-9 is a widely used instrument to measure symptoms of depression. This set of 9 questions asked participants to respond to statements pertaining to their mental health in the preceding 2 weeks. The score range for the instrument is 0-27, with higher scores correlating with higher levels of symptoms of depression. Additionally, there is 1 question, not scored, rating difficulty of problems.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPatient Health Questionnaire-9T15.29 units on a scaleStandard Deviation 5.88
Intervention ArmPatient Health Questionnaire-9T25.43 units on a scaleStandard Deviation 6.03
Intervention ArmPatient Health Questionnaire-9T34.30 units on a scaleStandard Deviation 4.87
Intervention ArmPatient Health Questionnaire-9T45.38 units on a scaleStandard Deviation 6.06
Wait-list Control ArmPatient Health Questionnaire-9T44.92 units on a scaleStandard Deviation 5.7
Wait-list Control ArmPatient Health Questionnaire-9T35.50 units on a scaleStandard Deviation 5.98
Wait-list Control ArmPatient Health Questionnaire-9T17.22 units on a scaleStandard Deviation 7.47
Wait-list Control ArmPatient Health Questionnaire-9T54.45 units on a scaleStandard Deviation 5.45
Wait-list Control ArmPatient Health Questionnaire-9T26.24 units on a scaleStandard Deviation 6.2
p-value: 0.83Mixed Models Analysis
Secondary

PROMIS Emotional Support

Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's perception of availability of trusted individuals in their life to provide emotional support, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPROMIS Emotional SupportT152.71 units on a scaleStandard Deviation 9.65
Intervention ArmPROMIS Emotional SupportT253.31 units on a scaleStandard Deviation 8.9
Intervention ArmPROMIS Emotional SupportT353.29 units on a scaleStandard Deviation 9.09
Intervention ArmPROMIS Emotional SupportT453.16 units on a scaleStandard Deviation 8.62
Wait-list Control ArmPROMIS Emotional SupportT454.96 units on a scaleStandard Deviation 8.35
Wait-list Control ArmPROMIS Emotional SupportT352.32 units on a scaleStandard Deviation 10.03
Wait-list Control ArmPROMIS Emotional SupportT151.65 units on a scaleStandard Deviation 11.09
Wait-list Control ArmPROMIS Emotional SupportT553.35 units on a scaleStandard Deviation 9.05
Wait-list Control ArmPROMIS Emotional SupportT253.36 units on a scaleStandard Deviation 9.28
p-value: 0.6Mixed Models Analysis
Secondary

PROMIS Physical Function

Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the function of upper/lower extremities, core, and ability to perform activities of daily living, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPROMIS Physical FunctionT144.94 units on a scaleStandard Deviation 8.81
Intervention ArmPROMIS Physical FunctionT245.83 units on a scaleStandard Deviation 9.08
Intervention ArmPROMIS Physical FunctionT345.00 units on a scaleStandard Deviation 10.17
Intervention ArmPROMIS Physical FunctionT445.91 units on a scaleStandard Deviation 10.48
Wait-list Control ArmPROMIS Physical FunctionT444.81 units on a scaleStandard Deviation 9.86
Wait-list Control ArmPROMIS Physical FunctionT345.23 units on a scaleStandard Deviation 9.28
Wait-list Control ArmPROMIS Physical FunctionT145.49 units on a scaleStandard Deviation 8.74
Wait-list Control ArmPROMIS Physical FunctionT545.82 units on a scaleStandard Deviation 8.88
Wait-list Control ArmPROMIS Physical FunctionT245.55 units on a scaleStandard Deviation 8.52
p-value: 0.49Mixed Models Analysis
Secondary

PROMIS Positive Affect and Well-being

Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's recent sense of well-being and agreement with positive outlook and experience of life, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPROMIS Positive Affect and Well-beingT156.32 units on a scaleStandard Deviation 7.92
Intervention ArmPROMIS Positive Affect and Well-beingT257.84 units on a scaleStandard Deviation 8.18
Intervention ArmPROMIS Positive Affect and Well-beingT357.64 units on a scaleStandard Deviation 7.65
Intervention ArmPROMIS Positive Affect and Well-beingT458.50 units on a scaleStandard Deviation 8.34
Wait-list Control ArmPROMIS Positive Affect and Well-beingT458.64 units on a scaleStandard Deviation 7.54
Wait-list Control ArmPROMIS Positive Affect and Well-beingT357.15 units on a scaleStandard Deviation 8.37
Wait-list Control ArmPROMIS Positive Affect and Well-beingT156.37 units on a scaleStandard Deviation 8.98
Wait-list Control ArmPROMIS Positive Affect and Well-beingT558.35 units on a scaleStandard Deviation 6.93
Wait-list Control ArmPROMIS Positive Affect and Well-beingT257.37 units on a scaleStandard Deviation 8.42
p-value: 0.97Mixed Models Analysis
Secondary

PROMIS Satisfaction With Social Roles and Activities

Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's satisfaction with and ability to participant in social roles and activities, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPROMIS Satisfaction With Social Roles and ActivitiesT153.62 units on a scaleStandard Deviation 10.11
Intervention ArmPROMIS Satisfaction With Social Roles and ActivitiesT253.26 units on a scaleStandard Deviation 10.76
Intervention ArmPROMIS Satisfaction With Social Roles and ActivitiesT353.61 units on a scaleStandard Deviation 10.01
Intervention ArmPROMIS Satisfaction With Social Roles and ActivitiesT453.00 units on a scaleStandard Deviation 9.89
Wait-list Control ArmPROMIS Satisfaction With Social Roles and ActivitiesT455.10 units on a scaleStandard Deviation 9.36
Wait-list Control ArmPROMIS Satisfaction With Social Roles and ActivitiesT354.05 units on a scaleStandard Deviation 9.27
Wait-list Control ArmPROMIS Satisfaction With Social Roles and ActivitiesT154.03 units on a scaleStandard Deviation 9.62
Wait-list Control ArmPROMIS Satisfaction With Social Roles and ActivitiesT555.00 units on a scaleStandard Deviation 9.17
Wait-list Control ArmPROMIS Satisfaction With Social Roles and ActivitiesT253.65 units on a scaleStandard Deviation 9.64
p-value: 0.58Mixed Models Analysis
Secondary

PROMIS Self-efficacy for Managing Emotions

Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the participant's current confidence to manage emotional distress and stressful situations core, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPROMIS Self-efficacy for Managing EmotionsT148.18 units on a scaleStandard Deviation 9.13
Intervention ArmPROMIS Self-efficacy for Managing EmotionsT250.00 units on a scaleStandard Deviation 9.3
Intervention ArmPROMIS Self-efficacy for Managing EmotionsT350.15 units on a scaleStandard Deviation 8.78
Intervention ArmPROMIS Self-efficacy for Managing EmotionsT451.85 units on a scaleStandard Deviation 9.37
Wait-list Control ArmPROMIS Self-efficacy for Managing EmotionsT451.70 units on a scaleStandard Deviation 8.79
Wait-list Control ArmPROMIS Self-efficacy for Managing EmotionsT349.90 units on a scaleStandard Deviation 8.77
Wait-list Control ArmPROMIS Self-efficacy for Managing EmotionsT148.28 units on a scaleStandard Deviation 9.84
Wait-list Control ArmPROMIS Self-efficacy for Managing EmotionsT551.01 units on a scaleStandard Deviation 8.45
Wait-list Control ArmPROMIS Self-efficacy for Managing EmotionsT249.18 units on a scaleStandard Deviation 9.93
p-value: 0.77Mixed Models Analysis
Secondary

PROMIS Self-efficacy for Managing Social Interactions

Patient Reported Outcome Measurement Information System (PROMIS) measure. This 4 item form was used to assess the participant's current confidence in being able to access support in processing emotions and health problems, and obtain assistance with transportation and problem solving, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPROMIS Self-efficacy for Managing Social InteractionsT146.57 units on a scaleStandard Deviation 8.57
Intervention ArmPROMIS Self-efficacy for Managing Social InteractionsT247.13 units on a scaleStandard Deviation 8.54
Intervention ArmPROMIS Self-efficacy for Managing Social InteractionsT348.57 units on a scaleStandard Deviation 9.1
Intervention ArmPROMIS Self-efficacy for Managing Social InteractionsT447.29 units on a scaleStandard Deviation 8.94
Wait-list Control ArmPROMIS Self-efficacy for Managing Social InteractionsT449.20 units on a scaleStandard Deviation 8.58
Wait-list Control ArmPROMIS Self-efficacy for Managing Social InteractionsT347.18 units on a scaleStandard Deviation 9.74
Wait-list Control ArmPROMIS Self-efficacy for Managing Social InteractionsT147.44 units on a scaleStandard Deviation 9.74
Wait-list Control ArmPROMIS Self-efficacy for Managing Social InteractionsT549.17 units on a scaleStandard Deviation 8.6
Wait-list Control ArmPROMIS Self-efficacy for Managing Social InteractionsT247.86 units on a scaleStandard Deviation 8.99
p-value: <0.05Mixed Models Analysis
Secondary

PROMIS Self-Efficacy for Managing Symptoms

Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the participant's confidence in their ability to manage symptoms of chronic illness and prevent them from interfering from activities of daily living, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.

Time frame: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention ArmPROMIS Self-Efficacy for Managing SymptomsT149.33 units on a scaleStandard Deviation 9.64
Intervention ArmPROMIS Self-Efficacy for Managing SymptomsT248.48 units on a scaleStandard Deviation 9.36
Intervention ArmPROMIS Self-Efficacy for Managing SymptomsT350.45 units on a scaleStandard Deviation 8.96
Intervention ArmPROMIS Self-Efficacy for Managing SymptomsT449.55 units on a scaleStandard Deviation 9.86
Wait-list Control ArmPROMIS Self-Efficacy for Managing SymptomsT450.61 units on a scaleStandard Deviation 9.9
Wait-list Control ArmPROMIS Self-Efficacy for Managing SymptomsT348.93 units on a scaleStandard Deviation 9.67
Wait-list Control ArmPROMIS Self-Efficacy for Managing SymptomsT148.15 units on a scaleStandard Deviation 9.37
Wait-list Control ArmPROMIS Self-Efficacy for Managing SymptomsT550.63 units on a scaleStandard Deviation 9.94
Wait-list Control ArmPROMIS Self-Efficacy for Managing SymptomsT247.12 units on a scaleStandard Deviation 8.34
p-value: 0.69Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026