Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers

NCT05916664 | Completed Results

• 1 other identifier: FT001
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Alzheimer Disease; Lewy Body Disease; Vascular Dementia; Frontotemporal Dementia; Mixed Dementia

Keywords

Caregiving; Financial Education; Technology; Behavioral Intervention; Caregiver Support Intervention; Financial Literacy; Financial Preparedness; Caregiver Well Being; Caregiver Stress; Caregiver Burden

Outcome Measures

Primary Outcomes (7)

• 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.

  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).

• 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.

  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).

• 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.

  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).

• 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.

  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).

• 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.

  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).

• 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.

  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).

• 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.

  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 Outcomes (12)

• 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).

• 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).

• 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 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).

• 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).

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Kinto Care Coaching

Control

NO INTERVENTION

Control group that does not receive the Caregiver Support Intervention

Interventions

Kinto Care Coaching BEHAVIORAL

Describe the basics of the intervention

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be:
• 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

You may not qualify if:

• Participants can not:
• Currently be participating in another non-pharmacological intervention
• Have participated in a previous Kinto study

Sponsors & Collaborators

• Kinto: lead
• Alzheimer's Association: collaborator

Study Sites (1)

Alzheimer's Association Head Office

Chicago, Illinois, 60603, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Lewy Body Disease; Dementia, Vascular; Frontotemporal Dementia; Mixed Dementias; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Joseph T Chung
• Organization: RSV Opco 5, Inc. (dba Kinto)

joe@kinto.care

(857) 600-2273

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 23, 2023
• Study Start: May 18, 2023
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)