Project WellCAST (Supporting Wellbeing of Caregivers via Telehealth) is a multi-phase
research study that aims to develop a scalable, personalized health approach for supporting
caregivers of people with rare disorders. Two previous studies by this research team have
piloted individual interventions in subsets of rare disorder caregiving communities to
establish initial feasibility and acceptability. Now in its third phase, Project WellCAST 3.0
aims to generate a scalable, innovative model for personalizing digital treatments to
caregiver needs. This project has two specific aims:
AIM 1: Develop and optimize a personalized health algorithm to match neurogenetic syndrome
(NGC) caregivers to digital health treatments using a combination of standard clinical tools
and smartphone-based EMA data.
Extant clinical and EMA data on NGC caregiver response to COVID-19 was used to develop an
initial routing algorithm to match families to treatment type and intensity. This aim will
compare the effectiveness of algorithm-assigned treatment to "treatment as usual," optimizing
the algorithm across four waves of intervention. Interventions will be brief, evidence-based,
digital health treatments administered by highly supervised clinical trainees, a
cost-efficient model for directly targeting the secondary health effects of COVID-19.
AIM 2: Test the efficacy of peer-to-peer coaching, deployed by trained NGC caregivers using
an evidence-based motivational interviewing protocol, in enhancing treatment uptake and
clinical outcomes.
Peer coaches who are also NGC caregivers will be trained to deploy evidence-based
Participation Enhancement Interventions designed to support treatment engagement and reduce
potential barriers. This aim will evaluate the feasibility and effectiveness of this approach
in reducing secondary health effects of COVID-19 by comparing outcomes across participants
who were randomized to complete treatment with and without peer coaches. Peer coaches will
also provide valuable stakeholder input for designing and optimizing the digital treatment
network.
DETAILED HUMAN SUBJECTS PROCEDURE:
ENROLLMENT AND CONSENT 1. At the entry of the study, caregivers will be assessed by the study
team to determine eligibility. The caregivers will then consent to baseline collection. A
subset of caregivers will be enrolled at this phase as waitlist controls. Waitlist controls
will complete the same data collection described below, but without any support program.
BASELINE. The baseline period of the study lasts two weeks. During this time, caregivers will
complete initial study forms and "snapshot surveys," which are brief questionnaires sent
three times per day via their smartphones.
ROUTING. After baseline data collection is complete, caregivers will be routed to a support
program. Random number generators will be used to route caregivers to their study arm,
described below.
Caregivers may opt out of broadly completing either child-focused or self-focused treatments
but may not select their specific treatment modality. As an exception, any Black caregiver in
the study is eligible to add the CICBT group to their assigned support program.
CONSENT 2 and INTERVENTION. Participants will provide informed consent specific to their
assigned intervention then begin their 12-week support program. Programs are described below.
During intervention, caregivers will be asked to complete study forms to assess how their
characteristics and experiences have changed interventions; forms will be collected at start
of treatment, midpoint, and endpoint. Caregivers will also complete "snapshot surveys"
(3x/day) during this time.
FOLLOW UP. Two weeks after completing treatment, caregivers will complete follow-up forms and
a 2-week period of "snapshot surveys."
ADDITIONAL PROCEDURES:
This study will occur across four phases. Phases I and II will enroll up to 500 participants
(to yield 400 participants total) who will be randomly assigned to Algorithm (Algorithm 1
versus No Algorithm) and Peer Coaching (Peer Coaching versus No Peer Coaching).
After Phase II, investigators will convene a "think tank" that will evaluate primary and
secondary endpoints across arms, with the goal of determining how to optimize the algorithm.
Data analyses will be performed by staff who are not involved in clinical operations. Peer
coaches (who are rare disorder caregivers), clinicians, biostatisticians, and scientists will
collaboratively participate in this think tank, with the goal to optimize the algorithm prior
to Phase III.
Phase III will enroll up to 250 participants (to yield 200) who will receive the optimized
Algorithm 2 and be randomly assigned to Peer Coaching conditions. After Phase III, a second
think tank will be convened to optimize Algorithm 3.
Phase IV will enroll up to 250 participants (to yield 200) who will receive the optimized
Algorithm 3 and will be randomly assigned to Peer Coaching conditions.
Final analyses will compare Algorithm 3 to Algorithm 2, Algorithm 1, and Waitlist Controls.
RIGOR AND REPRODUCIBILITY.
Algorithms will be uploaded to a secure, locked site prior to each round of study assignment.
Analyses will be preregistered, and all code will be available for replication efforts.
Masking procedures are described elsewhere in this document.