Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers

Alzheimer Disease Clinical Trial

Official title:

Phase II Efficacy Study of a Technology-enabled Care Coaching Service for Families Caring for AD/ADRD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05916664
• Other study ID #: FT001
• Status: Completed
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: April 22, 2024

Study information

• Verified date: April 2024
• Source: Kinto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: April 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 smartphone, 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Dementia, Vascular
• Frontotemporal Dementia
• Lewy Body Disease
• Mixed Dementia
• Pick Disease of the Brain
• Vascular Dementia

Intervention

Behavioral:
• Kinto Care Coaching
Describe the basics of the intervention

Locations

Country	Name	City	State
United States	Alzheimer's Association Head Office	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Kinto	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 (0=strongly disagree to 3=strongly agree) with higher scores indicating greater 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).
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 (0=strongly disagree to 3=strongly agree) with higher scores indicating more 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).
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 (0=not at all to 3=a great deal) with higher scores indicating greater 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).
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 (0=not at all to 3=a great deal) with higher scores indicating greater 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).
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 (0=strongly disagree to 3=strongly agree) with lower scores indicating greater feelings of loneliness.	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).
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 (0=no knowledge to 4=expert knowledge) with higher scores indicating greater 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).
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 (0=never to 4=nearly always) with higher scores indicating greater 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).
Secondary	Caregiver Financial Unmet Needs	Caregiver Financial Unmet Needs is a 9-item self-report questionnaire that assesses an individual's financial unmet needs due to their caregiving role. Example items include Do you need more information about or help with how to manage your (RELATIONSHIP)'s finances such as bank accounts and paying bills? and Do you need more information about or help with finding out what your (RELATIONSHIP) wants if he/she is unable to speak for him/herself? The measure is scored using dichotomous yes/no scoring (0=no/1=yes) with higher scores indicating greater unmet financial needs.	Changes in financial 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).
Secondary	Caregiver Financial Unmet Needs Distress	Caregiver Financial Unmet Needs Distress is a 9-item self-report questionnaire that assesses the distress resulting from individual's financial unmet needs. Example items include How distressing or stressful is how to manage your (RELATIONSHIP)'s finances such as bank accounts and paying bills? and How distressing or stressful is finding out what your (RELATIONSHIP) wants if he/she is unable to speak for him/herself? The measure is scored using a 4-point Likert scale (0=not distressing to 3=very distressing) with higher scores indicating greater financial unmet needs distress.	Changes in financial 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).
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 (0=strongly disagree to 3=strongly agree) with higher scores indicating greater 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).
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 (0=strongly disagree to 3=strongly agree) with higher scores indicating greater 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 (4h5 days from T2).
Secondary	Caregiver Unmet Needs	Caregiver Unmet Needs is a 6-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 (0=no/1=yes) with higher scores indicating more 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
Secondary	Caregiver Unmet Needs Distress	Caregiver Unmet Needs Distress is a 6-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 (0=not distressing to 3=very distressing) with higher scores indicating greater distress due to caregiver unmet needs.	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).
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 (0=not at all to 3=nearly every day) with higher scores indicating more symptoms of 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).
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 (0=hardly ever to 2=often) with higher scores indicating more symptoms of 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).
Secondary	Social Support Unmet Needs	Social Support Unmet Needs is a 5-item self-report questionnaire that assesses the social support needs of caregivers. Example items include Do you need more information about or help with reaching out to professionals? and Finding a support group? The measure is scored using dichotomous yes/no scoring (0=no/1=yes) with higher scores indicating more unmet social support needs.	Changes in social support 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).
Secondary	Social Support Unmet Needs Distress	Social Support Unmet Needs Distress is a 5-item self-report questionnaire that assesses the resulting distress due to caregiver's unmet social support needs. Example items include How distressing or upsetting is reaching out to professional? and Finding a support group? The measure is scored using a 4-point Likert scale (0=not distressing to 3=very distressing) with higher scores indicating greater distress due to unmet social support needs.	Changes in social support distress due to 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).
Secondary	Instrumental Activities of Daily Living - Difficulty	Instrumental Activities of Daily Living - Difficulty is a 10-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 (0=not difficult to 3=very difficult) with higher scores indicating more difficulty in completing instrumental activities.	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).
Secondary	Instrumental Activities of Daily Living - Distress	Instrumental Activities of Daily Living - Distress is a 10-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 (0=not distressing to 3=very distressing) with higher scores indicating greater 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).
Secondary	Personal Activities of Daily Living - Difficulty	Personal Activities of Daily Living - Difficulty is a 6-item self-report questionnaire that assesses how much difficulty individuals with dementia experience in completing personal activities of daily living as reported by their caregivers. Example items include How difficult was eating, including cutting food or buttering bread? and Dressing or undressing? The measure is scored using a 4-point Likert scale (0=not to 3=very) with higher scores indicating more difficulty in completing personal activities.	Changes in personal 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).
Secondary	Personal Activities of Daily Living - Distress	Personal Activities of Daily Living - Distress is a 6-item self-report questionnaire that assesses the resulting distress caregivers experience due to personal activities of daily living difficulty. Example items include How distressing or upsetting was this for you when the person you care performed these activities: Eating, including cutting food or buttering bread? and Dressing or undressing? The measure is scored using a 4-point Likert scale (0=not distressing to 3=very distressing) with higher scores indicating greater distress.	Changes in personal 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).
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 (0=not difficult to 3=very difficult) with higher scores indicating more cognitive 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).
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 (0=not distressing to 3=very distressing) with higher scores indicating greater 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).
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 (0=none of the time to most or all of the time ) with higher scores indicating more frequent behaviors.	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).
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 (0=not distressing to 3=very distressing) with higher scores indicating greater 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).