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
- 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.