Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers

NCT ID: NCT05916664

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 495 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-18
• Study Completion Date: 2024-04-22

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Kinto Care Coaching

Intervention Type: BEHAVIORAL

Describe the basics of the intervention

Control

Control group that does not receive the Caregiver Support Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kinto Care Coaching

Describe the basics of the intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alzheimer's Association

OTHER

Sponsor Role: collaborator

Kinto

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alzheimer's Association Head Office

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FT001

Identifier Type: -

Identifier Source: org_study_id