Alzheimer Disease, Dementia, Frontotemporal Dementia, Lewy Body Disease, Mixed Dementia, Vascular Dementia
Conditions
Keywords
Caregiving, Financial Education, Technology, Behavioral Intervention, Caregiver Support Intervention, Financial Literacy, Financial Preparedness, Caregiver Well Being, Caregiver Stress, Caregiver Burden
Brief summary
The goal of this clinical trial is to evaluate Kinto's Care Coaching intervention for dementia caregivers. The main questions it aims to answer are: Does the intervention help caregivers to address their general caregiving goals Does the intervention help caregivers to address their financial caregiving goals Participants will have access to: One-on-one care coaching sessions (via zoom) Up to 6 weekly support groups with other caregivers A variety of digital resources through Kinto's mobile app Researchers will compare intervention and control groups to see if the program supports caregivers' general and financial caregiving needs. The efficacy of the intervention also will be examined on key outcomes.
Detailed description
The study will include 300 family caregivers drawn from throughout the US, who will engage remotely with the coaches (and one another) using zoom and Kinto's mobile caregiver app. Caregivers will be randomly assigned to one of two groups to evaluate the impact of the program by making a comparison of those caregivers who received the program (Group 1\) and those caregivers who will not receive the program (Group 2). Caregivers assigned to Group 2, the control condition, will be eligible to receive a modified version of the program after completion of the study and data collection protocols. The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled. Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app. As guided by the NIH Stage Model for Behavioral Intervention Development, the primary goal of the Phase 2 study is to examine the efficacy of the program on select outcomes for caregivers (i.e., Stage III Real-World Efficacy). As such, the selected data collection periods of T1 (prior to the intervention), T2 (immediately following the initial six week intervention period) and T3 (45 days following this date) will evaluate the immediate and short-term efficacy of the program. Recruiting of caregivers is scheduled to begin in May 2023. The study plan targets recruitment of three cohorts, each with one hundred participants. The first intervention group will begin the program in August 2023. Subsequent cohorts will begin the study at 8-9 week intervals. The plan includes a contingency to run two additional cohorts (to mitigate any recruitment or retention risk). In the event that all five cohorts are used to achieve participation goals, the final cohort is scheduled to complete the intervention and survey requirements no later than August of 2024.
Interventions
BEHAVIORALKinto Care Coaching
Describe the basics of the intervention
Sponsors
Alzheimer's Association
Kinto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants must be: * 18 years or older * Caring for a family member or close friend with dementia or memory loss * Providing 5 or more hours of care or support each week * Not getting paid for the care/support * Fluent in English, or both Spanish and English * Living in the United States They must: ● Have access to a smart phone, reliable internet service and an email address
Exclusion criteria
Participants can not: * Currently be participating in another non-pharmacological intervention * Have participated in a previous Kinto study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Mastery | Changes in caregiver mastery between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Caregiver Mastery is a 9-item self-report questionnaire that assesses how competent individuals feel in their role as caregivers of individuals with dementia. Example items include I became more self-confident in providing care and I felt I was pretty good at figuring out what he/she needed. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater caregiver mastery. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater caregiver mastery. |
| Emotional Health Strain | Changes in emotional health strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Emotional Health Strain is a 4-item self-report questionnaire that assesses how emotionally strained individuals feel in their role as caregivers of individuals with dementia. Example items include I was under more stress, strain, or pressure and I was more nervous or bothered by nerves than before. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating more emotional health strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater emotional health strain. |
| Personal Gain | Changes in personal gain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Personal Gain is a 4-item self-report questionnaire that assesses the personal gain experienced by individuals in their role as caregivers of individuals with dementia. Example items include Become more aware of your inner strengths and Become more self-confident. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater personal gain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater personal gain. |
| Financial Self-Efficacy | Changes in financial self-efficacy between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Financial Self-Efficacy is a 10-item self-report questionnaire that assesses how efficacious individuals feel in their financial preparedness and skills for managing money as related to their caregiving role. Example items include I am confident that I will be able to successfully manage my loved one's finances and I feel confident in talking with my loved one about their finances. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater financial self-efficacy. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater financial self-efficacy. |
| ULS-8 Loneliness Scale | Changes in loneliness between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | The ULS-8 Loneliness Scale is an 11 item self-report questionnaire that assesses how lonely individuals feel with 8 original items and 3 additional items. Example items include I feel very close to one or more people and There are people who really understand me. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with lower scores indicating greater feelings of loneliness. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with lower scores indicating greater feelings of loneliness. |
| Perceived Financial Knowledge | Changes in perceived financial knowledge between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Perceived Financial Knowledge is a 1-item self-report questionnaire that assesses an individual's perceived knowledge about their financial preparedness and skills for managing money as related to their caregiving role. The item states Please rate your current understanding of how to manage money for you or the person you are caring for. The measure is scored using a 5-point Likert scale (1=no knowledge to 5=expert knowledge) with higher scores indicating greater perceived financial knowledge. |
| Caregiver Burden | Changes in caregiver burden between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Caregiver Burden is a 4-item self-report questionnaire that assesses how much strain and stress individuals feel in their caregiving role for individuals with dementia. Example items include Do you feel that because of the time you spend with your relative that you don't have enough time for yourself and Do you feel stressed between caring for your relative and trying to meet other responsibilities (work/family)? The measure is scored using a 5-point Likert scale (1=never to 5=nearly always) with higher scores indicating greater caregiver burden. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 5, with higher scores indicating greater caregiver burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Instrumental and Personal Activities of Daily Living - Distress | Changes in instrumental activities of daily living distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Instrumental Activities of Daily Living - Distress is a 16-item self-report questionnaire that assesses the resulting distress caregivers experience due to the amount of instrumental activities of daily living difficulty experienced by the individual they care for. Example items include How distressing or upsetting was this for you when the person you care performed these activities: Writing checks, paying bills, or balancing a checkbook? and Preparing a balanced meal? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress. |
| Cognition - Difficulty | Changes in cognitive difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Cognition - Difficulty is an 8-item self-report questionnaire that assesses how much difficulty individuals with dementia experience with their cognition as reported by their caregivers. Example items include How difficult was remembering recent events? and Knowing what day of the week it is? The measure is scored using a 4-point Likert scale (1=not difficult to 4=very difficult) with higher scores indicating more cognitive difficulty. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more cognitive difficulty. |
| Dyadic Relationship Strain | Changes in relationship strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Dyadic Relationship Strain is a 7-item self-report questionnaire that assesses how strained individuals feel because of their caregiving relationship. Example items include I felt my relationship with him/her was strained and I felt resentful toward him/her. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater relationship strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater relationship strain. |
| Behaviors - Frequency | Changes in behavioral frequency between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Behaviors - Frequency is a 14-item self-report questionnaire that assesses the frequency in which individuals with dementia experience dementia-related behaviors as reported by their caregivers. Example items include How often did the person you care for act confused? and Talk or mumble to himself/herself? The measure is scored using a 4-point Likert scale (1=none of the time to 4=most or all of the time ) with higher scores indicating more frequent behaviors. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more frequent behaviors. |
| Behaviors - Distress | Changes in behavioral distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Behaviors - Distress is a 14-item self-report questionnaire that assesses the resulting distress caregivers experience due to the behaviors of individuals with dementia. Example items in reference to the person they are caring for include How distressing or upsetting was this for you: Act confused? and Talk or mumble to himself/herself? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress. |
| Cognition - Distress | Changes in cognitive distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Cognition - Distress is an 8-item self-report questionnaire that assesses the resulting distress caregivers experience due to the amount of cognitive difficulty experienced by the person they care for. Example items in reference to the person they are caring for include How distressing or upsetting was this for you: Remembering recent events? and Knowing what day of the week it is? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress. |
| Role Captivity | Changes in role captivity between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Role Captivity is a 3-item self-report questionnaire that assesses the extent to which individuals feel trapped in their role as a caregiver. Example items include I wished I were free to lead my own life and I felt trapped having to care for him/her. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater role captivity. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater role captivity. |
| Caregiver Unmet Needs | Changes in unmet needs between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Caregiver Unmet Needs is a 20-item self-report questionnaire that assesses unmet needs of caregivers. Example items include Do you need more information or help with understanding basic information about dementia? and Ideas to assist with your personal wellbeing as a caregiver? The measure is scored using dichotomous yes/no scoring (1=no/2=yes) with higher scores indicating more unmet needs. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 2, with higher scores indicating more unmet needs. |
| Caregiver Unmet Needs Distress | Changes in unmet needs distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Caregiver Unmet Needs Distress is a 20-item self-report questionnaire that assesses the resulting distress due to caregiver unmet needs. Example items include How distressing or upsetting is understanding basic information about dementia? and Ideas to assist with your personal wellbeing as a caregiver? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress due to caregiver unmet needs. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress due to caregiver unmet needs. |
| Anxiety | Changes in anxiety symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Anxiety is a 7-item self-report questionnaire that assesses symptoms of anxiety. Example items include Feel nervous, anxious or on edge and Feel that you could not stop or control worrying? The measure is scored using a 4-point Likert scale (1=not at all to 4=nearly every day) with higher scores indicating more symptoms of anxiety. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more symptoms of anxiety. |
| Depression | Changes in depressive symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Depression is an 11-item self-report questionnaire that assesses symptoms of depression. Example items include Feel depressed and Feel that everything you did was an effort? The measure is scored using a 3-point Likert scale (1=hardly ever to 3=often) with higher scores indicating more symptoms of depression. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 3, with higher scores indicating more symptoms of depression. |
| Instrumental and Personal Activities of Daily Living - Difficulty | Changes in instrumental activities of daily living difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2). | Instrumental and Personal Activities of Daily Living - Difficulty is a 16-item self-report questionnaire that assesses how much difficulty individuals with dementia experience in completing daily tasks as reported by their caregivers. Example items include How difficult was writing checks, paying bills, or balancing a checkbook? and Preparing a balanced meal? The measure is scored using a 4-point Likert scale (1=not difficult to 4=very difficult) with higher scores indicating more difficulty in completing instrumental activities. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more difficulty in completing instrumental activities. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place between 5/10/23 and 11/30/23. Recruitment and participation in the study occurred remotely.
Participants by arm
| Arm | Count |
|---|---|
| Intervention The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention | 137 |
| Control Control group that does not receive the Caregiver Support Intervention | 192 |
| Total | 329 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 58.57 years STANDARD_DEVIATION 12.27 | 53.91 years STANDARD_DEVIATION 13.24 | 55.75 years STANDARD_DEVIATION 13.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 28 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants | 161 Participants | 281 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 37 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) White | 95 Participants | 138 Participants | 233 Participants |
| Region of Enrollment United States | 137 participants | 192 participants | 329 participants |
| Sex/Gender, Customized Female | 111 Participants | 142 Participants | 253 Participants |
| Sex/Gender, Customized Male | 24 Participants | 45 Participants | 69 Participants |
| Sex/Gender, Customized Other / Missing | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 192 |
| other Total, other adverse events | 0 / 137 | 0 / 192 |
| serious Total, serious adverse events | 0 / 137 | 0 / 192 |
Outcome results
Primary
Caregiver Burden
Caregiver Burden is a 4-item self-report questionnaire that assesses how much strain and stress individuals feel in their caregiving role for individuals with dementia. Example items include Do you feel that because of the time you spend with your relative that you don't have enough time for yourself and Do you feel stressed between caring for your relative and trying to meet other responsibilities (work/family)? The measure is scored using a 5-point Likert scale (1=never to 5=nearly always) with higher scores indicating greater caregiver burden. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 5, with higher scores indicating greater caregiver burden.
Time frame: Changes in caregiver burden between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Caregiver Burden | T1 | 3.16 score on a scale | Standard Deviation 0.79 |
| Intervention | Caregiver Burden | T2 | 2.87 score on a scale | Standard Deviation 0.85 |
| Intervention | Caregiver Burden | T3 | 2.82 score on a scale | Standard Deviation 0.86 |
| Control | Caregiver Burden | T1 | 3.23 score on a scale | Standard Deviation 0.87 |
| Control | Caregiver Burden | T2 | 3.05 score on a scale | Standard Deviation 0.83 |
| Control | Caregiver Burden | T3 | 3.10 score on a scale | Standard Deviation 0.9 |
Primary
Caregiver Mastery
Caregiver Mastery is a 9-item self-report questionnaire that assesses how competent individuals feel in their role as caregivers of individuals with dementia. Example items include I became more self-confident in providing care and I felt I was pretty good at figuring out what he/she needed. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater caregiver mastery. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater caregiver mastery.
Time frame: Changes in caregiver mastery between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Caregiver Mastery | T1 | 2.80 score on a scale | Standard Deviation 0.43 |
| Intervention | Caregiver Mastery | T2 | 3.04 score on a scale | Standard Deviation 0.41 |
| Intervention | Caregiver Mastery | T3 | 3.07 score on a scale | Standard Deviation 0.45 |
| Control | Caregiver Mastery | T1 | 2.80 score on a scale | Standard Deviation 0.47 |
| Control | Caregiver Mastery | T2 | 2.90 score on a scale | Standard Deviation 0.45 |
| Control | Caregiver Mastery | T3 | 2.92 score on a scale | Standard Deviation 0.43 |
Primary
Emotional Health Strain
Emotional Health Strain is a 4-item self-report questionnaire that assesses how emotionally strained individuals feel in their role as caregivers of individuals with dementia. Example items include I was under more stress, strain, or pressure and I was more nervous or bothered by nerves than before. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating more emotional health strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater emotional health strain.
Time frame: Changes in emotional health strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Emotional Health Strain | T1 | 2.95 score on a scale | Standard Deviation 0.78 |
| Intervention | Emotional Health Strain | T2 | 2.46 score on a scale | Standard Deviation 0.85 |
| Intervention | Emotional Health Strain | T3 | 2.47 score on a scale | Standard Deviation 0.87 |
| Control | Emotional Health Strain | T1 | 2.86 score on a scale | Standard Deviation 0.82 |
| Control | Emotional Health Strain | T2 | 2.64 score on a scale | Standard Deviation 0.81 |
| Control | Emotional Health Strain | T3 | 2.67 score on a scale | Standard Deviation 0.76 |
Primary
Financial Self-Efficacy
Financial Self-Efficacy is a 10-item self-report questionnaire that assesses how efficacious individuals feel in their financial preparedness and skills for managing money as related to their caregiving role. Example items include I am confident that I will be able to successfully manage my loved one's finances and I feel confident in talking with my loved one about their finances. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater financial self-efficacy. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater financial self-efficacy.
Time frame: Changes in financial self-efficacy between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Financial Self-Efficacy | T1 | 2.81 score on a scale | Standard Deviation 0.6 |
| Intervention | Financial Self-Efficacy | T2 | 3.08 score on a scale | Standard Deviation 0.63 |
| Intervention | Financial Self-Efficacy | T3 | 3.14 score on a scale | Standard Deviation 0.64 |
| Control | Financial Self-Efficacy | T1 | 2.77 score on a scale | Standard Deviation 0.68 |
| Control | Financial Self-Efficacy | T2 | 2.87 score on a scale | Standard Deviation 0.69 |
| Control | Financial Self-Efficacy | T3 | 2.97 score on a scale | Standard Deviation 0.63 |
Primary
Perceived Financial Knowledge
Perceived Financial Knowledge is a 1-item self-report questionnaire that assesses an individual's perceived knowledge about their financial preparedness and skills for managing money as related to their caregiving role. The item states Please rate your current understanding of how to manage money for you or the person you are caring for. The measure is scored using a 5-point Likert scale (1=no knowledge to 5=expert knowledge) with higher scores indicating greater perceived financial knowledge.
Time frame: Changes in perceived financial knowledge between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Perceived Financial Knowledge | T1 | 3.45 score on a scale | Standard Deviation 0.93 |
| Intervention | Perceived Financial Knowledge | T2 | 3.78 score on a scale | Standard Deviation 0.83 |
| Intervention | Perceived Financial Knowledge | T3 | 3.79 score on a scale | Standard Deviation 0.84 |
| Control | Perceived Financial Knowledge | T1 | 3.42 score on a scale | Standard Deviation 0.95 |
| Control | Perceived Financial Knowledge | T2 | 3.55 score on a scale | Standard Deviation 0.87 |
| Control | Perceived Financial Knowledge | T3 | 3.59 score on a scale | Standard Deviation 0.9 |
Primary
Personal Gain
Personal Gain is a 4-item self-report questionnaire that assesses the personal gain experienced by individuals in their role as caregivers of individuals with dementia. Example items include Become more aware of your inner strengths and Become more self-confident. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater personal gain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater personal gain.
Time frame: Changes in personal gain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Personal Gain | T1 | 2.56 score on a scale | Standard Deviation 0.84 |
| Intervention | Personal Gain | T2 | 2.73 score on a scale | Standard Deviation 0.84 |
| Intervention | Personal Gain | T3 | 2.77 score on a scale | Standard Deviation 0.82 |
| Control | Personal Gain | T1 | 2.53 score on a scale | Standard Deviation 0.77 |
| Control | Personal Gain | T2 | 2.54 score on a scale | Standard Deviation 0.77 |
| Control | Personal Gain | T3 | 2.55 score on a scale | Standard Deviation 0.8 |
Primary
ULS-8 Loneliness Scale
The ULS-8 Loneliness Scale is an 11 item self-report questionnaire that assesses how lonely individuals feel with 8 original items and 3 additional items. Example items include I feel very close to one or more people and There are people who really understand me. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with lower scores indicating greater feelings of loneliness. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with lower scores indicating greater feelings of loneliness.
Time frame: Changes in loneliness between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | ULS-8 Loneliness Scale | T1 | 2.89 score on a scale | Standard Deviation 0.51 |
| Intervention | ULS-8 Loneliness Scale | T2 | 2.97 score on a scale | Standard Deviation 0.5 |
| Intervention | ULS-8 Loneliness Scale | T3 | 2.96 score on a scale | Standard Deviation 0.49 |
| Control | ULS-8 Loneliness Scale | T1 | 2.86 score on a scale | Standard Deviation 0.52 |
| Control | ULS-8 Loneliness Scale | T2 | 2.84 score on a scale | Standard Deviation 0.52 |
| Control | ULS-8 Loneliness Scale | T3 | 2.86 score on a scale | Standard Deviation 0.58 |
Secondary
Anxiety
Anxiety is a 7-item self-report questionnaire that assesses symptoms of anxiety. Example items include Feel nervous, anxious or on edge and Feel that you could not stop or control worrying? The measure is scored using a 4-point Likert scale (1=not at all to 4=nearly every day) with higher scores indicating more symptoms of anxiety. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more symptoms of anxiety.
Time frame: Changes in anxiety symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Anxiety | T1 | 2.17 score on a scale | Standard Deviation 0.82 |
| Intervention | Anxiety | T2 | 1.92 score on a scale | Standard Deviation 0.85 |
| Intervention | Anxiety | T3 | 1.92 score on a scale | Standard Deviation 0.8 |
| Control | Anxiety | T1 | 2.18 score on a scale | Standard Deviation 0.81 |
| Control | Anxiety | T2 | 2.06 score on a scale | Standard Deviation 0.79 |
| Control | Anxiety | T3 | 2.09 score on a scale | Standard Deviation 0.78 |
Secondary
Behaviors - Distress
Behaviors - Distress is a 14-item self-report questionnaire that assesses the resulting distress caregivers experience due to the behaviors of individuals with dementia. Example items in reference to the person they are caring for include How distressing or upsetting was this for you: Act confused? and Talk or mumble to himself/herself? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Time frame: Changes in behavioral distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Behaviors - Distress | T1 | 1.98 score on a scale | Standard Deviation 0.65 |
| Intervention | Behaviors - Distress | T2 | 1.73 score on a scale | Standard Deviation 0.57 |
| Intervention | Behaviors - Distress | T3 | 1.84 score on a scale | Standard Deviation 0.58 |
| Control | Behaviors - Distress | T1 | 1.98 score on a scale | Standard Deviation 0.72 |
| Control | Behaviors - Distress | T2 | 1.92 score on a scale | Standard Deviation 0.62 |
| Control | Behaviors - Distress | T3 | 1.92 score on a scale | Standard Deviation 0.62 |
Secondary
Behaviors - Frequency
Behaviors - Frequency is a 14-item self-report questionnaire that assesses the frequency in which individuals with dementia experience dementia-related behaviors as reported by their caregivers. Example items include How often did the person you care for act confused? and Talk or mumble to himself/herself? The measure is scored using a 4-point Likert scale (1=none of the time to 4=most or all of the time ) with higher scores indicating more frequent behaviors. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more frequent behaviors.
Time frame: Changes in behavioral frequency between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Behaviors - Frequency | T1 | 2.13 score on a scale | Standard Deviation 0.56 |
| Intervention | Behaviors - Frequency | T2 | 1.95 score on a scale | Standard Deviation 0.5 |
| Intervention | Behaviors - Frequency | T3 | 2.03 score on a scale | Standard Deviation 0.52 |
| Control | Behaviors - Frequency | T1 | 2.08 score on a scale | Standard Deviation 0.6 |
| Control | Behaviors - Frequency | T2 | 2.06 score on a scale | Standard Deviation 0.55 |
| Control | Behaviors - Frequency | T3 | 2.07 score on a scale | Standard Deviation 0.5 |
Secondary
Caregiver Unmet Needs
Caregiver Unmet Needs is a 20-item self-report questionnaire that assesses unmet needs of caregivers. Example items include Do you need more information or help with understanding basic information about dementia? and Ideas to assist with your personal wellbeing as a caregiver? The measure is scored using dichotomous yes/no scoring (1=no/2=yes) with higher scores indicating more unmet needs. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 2, with higher scores indicating more unmet needs.
Time frame: Changes in unmet needs between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Caregiver Unmet Needs | T1 | 1.67 score on a scale | Standard Deviation 0.21 |
| Intervention | Caregiver Unmet Needs | T2 | 1.36 score on a scale | Standard Deviation 0.26 |
| Intervention | Caregiver Unmet Needs | T3 | 1.33 score on a scale | Standard Deviation 0.27 |
| Control | Caregiver Unmet Needs | T1 | 1.70 score on a scale | Standard Deviation 0.25 |
| Control | Caregiver Unmet Needs | T2 | 1.56 score on a scale | Standard Deviation 0.26 |
| Control | Caregiver Unmet Needs | T3 | 1.52 score on a scale | Standard Deviation 0.27 |
Secondary
Caregiver Unmet Needs Distress
Caregiver Unmet Needs Distress is a 20-item self-report questionnaire that assesses the resulting distress due to caregiver unmet needs. Example items include How distressing or upsetting is understanding basic information about dementia? and Ideas to assist with your personal wellbeing as a caregiver? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress due to caregiver unmet needs. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress due to caregiver unmet needs.
Time frame: Changes in unmet needs distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Caregiver Unmet Needs Distress | T1 | 2.39 score on a scale | Standard Deviation 0.59 |
| Intervention | Caregiver Unmet Needs Distress | T2 | 1.86 score on a scale | Standard Deviation 0.57 |
| Intervention | Caregiver Unmet Needs Distress | T3 | 1.79 score on a scale | Standard Deviation 0.58 |
| Control | Caregiver Unmet Needs Distress | T1 | 2.45 score on a scale | Standard Deviation 0.68 |
| Control | Caregiver Unmet Needs Distress | T2 | 2.29 score on a scale | Standard Deviation 0.69 |
| Control | Caregiver Unmet Needs Distress | T3 | 2.18 score on a scale | Standard Deviation 0.67 |
Secondary
Cognition - Difficulty
Cognition - Difficulty is an 8-item self-report questionnaire that assesses how much difficulty individuals with dementia experience with their cognition as reported by their caregivers. Example items include How difficult was remembering recent events? and Knowing what day of the week it is? The measure is scored using a 4-point Likert scale (1=not difficult to 4=very difficult) with higher scores indicating more cognitive difficulty. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more cognitive difficulty.
Time frame: Changes in cognitive difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Cognition - Difficulty | T3 | 2.60 score on a scale | Standard Deviation 0.79 |
| Intervention | Cognition - Difficulty | T1 | 2.65 score on a scale | Standard Deviation 0.71 |
| Intervention | Cognition - Difficulty | T2 | 2.52 score on a scale | Standard Deviation 0.79 |
| Control | Cognition - Difficulty | T1 | 2.62 score on a scale | Standard Deviation 0.78 |
| Control | Cognition - Difficulty | T2 | 2.50 score on a scale | Standard Deviation 0.79 |
| Control | Cognition - Difficulty | T3 | 2.57 score on a scale | Standard Deviation 0.76 |
Secondary
Cognition - Distress
Cognition - Distress is an 8-item self-report questionnaire that assesses the resulting distress caregivers experience due to the amount of cognitive difficulty experienced by the person they care for. Example items in reference to the person they are caring for include How distressing or upsetting was this for you: Remembering recent events? and Knowing what day of the week it is? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Time frame: Changes in cognitive distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Cognition - Distress | T1 | 2.02 score on a scale | Standard Deviation 0.77 |
| Intervention | Cognition - Distress | T2 | 1.82 score on a scale | Standard Deviation 0.76 |
| Intervention | Cognition - Distress | T3 | 1.85 score on a scale | Standard Deviation 0.75 |
| Control | Cognition - Distress | T1 | 2.08 score on a scale | Standard Deviation 0.87 |
| Control | Cognition - Distress | T2 | 1.98 score on a scale | Standard Deviation 0.8 |
| Control | Cognition - Distress | T3 | 2.01 score on a scale | Standard Deviation 0.78 |
Secondary
Depression
Depression is an 11-item self-report questionnaire that assesses symptoms of depression. Example items include Feel depressed and Feel that everything you did was an effort? The measure is scored using a 3-point Likert scale (1=hardly ever to 3=often) with higher scores indicating more symptoms of depression. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 3, with higher scores indicating more symptoms of depression.
Time frame: Changes in depressive symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Depression | T1 | 1.68 score on a scale | Standard Deviation 0.44 |
| Intervention | Depression | T2 | 1.59 score on a scale | Standard Deviation 0.43 |
| Intervention | Depression | T3 | 1.58 score on a scale | Standard Deviation 0.43 |
| Control | Depression | T1 | 1.73 score on a scale | Standard Deviation 0.44 |
| Control | Depression | T2 | 1.71 score on a scale | Standard Deviation 0.45 |
| Control | Depression | T3 | 1.70 score on a scale | Standard Deviation 0.42 |
Secondary
Dyadic Relationship Strain
Dyadic Relationship Strain is a 7-item self-report questionnaire that assesses how strained individuals feel because of their caregiving relationship. Example items include I felt my relationship with him/her was strained and I felt resentful toward him/her. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater relationship strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater relationship strain.
Time frame: Changes in relationship strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Dyadic Relationship Strain | T1 | 2.22 score on a scale | Standard Deviation 0.74 |
| Intervention | Dyadic Relationship Strain | T2 | 1.98 score on a scale | Standard Deviation 0.72 |
| Intervention | Dyadic Relationship Strain | T3 | 2.00 score on a scale | Standard Deviation 0.74 |
| Control | Dyadic Relationship Strain | T1 | 2.21 score on a scale | Standard Deviation 0.7 |
| Control | Dyadic Relationship Strain | T2 | 2.08 score on a scale | Standard Deviation 0.66 |
| Control | Dyadic Relationship Strain | T3 | 2.13 score on a scale | Standard Deviation 0.71 |
Secondary
Instrumental and Personal Activities of Daily Living - Difficulty
Instrumental and Personal Activities of Daily Living - Difficulty is a 16-item self-report questionnaire that assesses how much difficulty individuals with dementia experience in completing daily tasks as reported by their caregivers. Example items include How difficult was writing checks, paying bills, or balancing a checkbook? and Preparing a balanced meal? The measure is scored using a 4-point Likert scale (1=not difficult to 4=very difficult) with higher scores indicating more difficulty in completing instrumental activities. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more difficulty in completing instrumental activities.
Time frame: Changes in instrumental activities of daily living difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Instrumental and Personal Activities of Daily Living - Difficulty | T1 | 2.48 score on a scale | Standard Deviation 0.82 |
| Intervention | Instrumental and Personal Activities of Daily Living - Difficulty | T2 | 2.49 score on a scale | Standard Deviation 0.85 |
| Intervention | Instrumental and Personal Activities of Daily Living - Difficulty | T3 | 2.55 score on a scale | Standard Deviation 0.88 |
| Control | Instrumental and Personal Activities of Daily Living - Difficulty | T1 | 2.44 score on a scale | Standard Deviation 0.87 |
| Control | Instrumental and Personal Activities of Daily Living - Difficulty | T2 | 2.39 score on a scale | Standard Deviation 0.82 |
| Control | Instrumental and Personal Activities of Daily Living - Difficulty | T3 | 2.45 score on a scale | Standard Deviation 0.79 |
Secondary
Instrumental and Personal Activities of Daily Living - Distress
Instrumental Activities of Daily Living - Distress is a 16-item self-report questionnaire that assesses the resulting distress caregivers experience due to the amount of instrumental activities of daily living difficulty experienced by the individual they care for. Example items include How distressing or upsetting was this for you when the person you care performed these activities: Writing checks, paying bills, or balancing a checkbook? and Preparing a balanced meal? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Time frame: Changes in instrumental activities of daily living distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Instrumental and Personal Activities of Daily Living - Distress | T1 | 2.08 score on a scale | Standard Deviation 0.73 |
| Intervention | Instrumental and Personal Activities of Daily Living - Distress | T2 | 1.95 score on a scale | Standard Deviation 0.83 |
| Intervention | Instrumental and Personal Activities of Daily Living - Distress | T3 | 1.93 score on a scale | Standard Deviation 0.79 |
| Control | Instrumental and Personal Activities of Daily Living - Distress | T1 | 2.10 score on a scale | Standard Deviation 0.83 |
| Control | Instrumental and Personal Activities of Daily Living - Distress | T2 | 2.04 score on a scale | Standard Deviation 0.72 |
| Control | Instrumental and Personal Activities of Daily Living - Distress | T3 | 2.07 score on a scale | Standard Deviation 0.81 |
Secondary
Role Captivity
Role Captivity is a 3-item self-report questionnaire that assesses the extent to which individuals feel trapped in their role as a caregiver. Example items include I wished I were free to lead my own life and I felt trapped having to care for him/her. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater role captivity. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater role captivity.
Time frame: Changes in role captivity between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Role Captivity | T1 | 2.46 score on a scale | Standard Deviation 0.86 |
| Intervention | Role Captivity | T2 | 2.23 score on a scale | Standard Deviation 0.84 |
| Intervention | Role Captivity | T3 | 2.17 score on a scale | Standard Deviation 0.84 |
| Control | Role Captivity | T1 | 2.41 score on a scale | Standard Deviation 0.83 |
| Control | Role Captivity | T2 | 2.38 score on a scale | Standard Deviation 0.85 |
| Control | Role Captivity | T3 | 2.38 score on a scale | Standard Deviation 0.85 |