Clinical trial NCT05999448: Promoting the Well Being of Caregivers Via Telehealth
Official title: Optimizing a Personalized Health Approach for Virtually Treating High-risk Caregivers During COVID-19 and Beyond
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregivers
Parents
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: University of Oregon
name: University of Canterbury
name: University of Missouri-Columbia
name: Indiana University
name: Georgia State University
First posted: 2023-08-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: For Waves I-II, caregivers are randomly assigned to either (1) route to a treatment using their personalized health data ("Algorithm 1") OR route to treatment randomly ("No Algorithm"); for Waves III and IV, caregivers are randomly assigned to Algorithm 1 or an optimized Algorithm 2 (Wave III) or Algorithm 2 or an optimized and final Algorithm 3 (Wave IV).

Across Waves I-IV, caregivers are randomly assigned to receive peer coaching ("Peer Coaching") or to receive check-ins by a staff member unfamiliar with the peer coaching protocol ("No Peer Coaching").

Across Waves I-III, a subset of caregivers are assigned to a waitlist control that does not include any treatment or peer coaching.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn which types of telehealth-based treatments best fit the needs of caregivers of people with rare neurogenetic conditions. The main questions it plans to answer are:

* Which telehealth support programs best meet the needs of rare disorder caregivers?
* How can individuals be matched to support programs that are right for them? What aspects of an individual (e.g., demographics, mental health symptoms, family characteristics, lifestyle) predict whether treatment will be a good fit?
* Does peer-to-peer coaching help improve patients' experiences during telehealth treatment?

Participants will be asked to complete a 12-week treatment program, which may include self-guided resources, individual therapies, group therapies, and/or peer-to-peer coaching.

Before, during, and after treatment, participants will complete questionnaires to help researchers understand their experiences, symptoms, and impressions of their support program. Questionnaires will include both standard forms (administered up to 5 times throughout the study) and brief "snapshot surveys" that participants complete on their smartphones up to 3 times per day.

Some participants will be assigned to a waitlist control, which means that they will provide data while they are not yet completing a support program. These participants will be assigned to a support program in the next treatment phase.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Caregiver and legal guardian of child age 2-35 with neurogenetic condition
* Child's syndrome must (1) have an established genetic cause, (2) affect the brain, resulting in moderate to severe intellectual disability in the majority of patients
* Reside in US
* Fluent in English (spoken and written)
* Seeking support for caregiver mental health/well-being and/or caregiving needs

Exclusion Criteria:

* Serious mental illness or active addiction that would be inadequately addressed through dosage of treatments
* Actively in treatment that would be redundant with those offered in the protocol
* Child's syndrome is not commonly associated with (1) life expectancy less than 35 years or (2) deterioration of previously gained skills.

Additional treatment-specific inclusion criteria are embedded in the experimental algorithm that will be adjusted through Aim 1.

Primary outcomes:
measure: Change from Baseline on DASS-21 Total-Score at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on PSOC Total Score at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on PSI-4-SF Total Score at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change in Average PANAS Negative Affect between Baseline and End-of-Treatment
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change in Average Momentary Stress between Baseline and End-of-Treatment
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on CGI-S at End-of-Treatment
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Clinical Global Impression-Improvement (CGI-I) at End-of-Treatment
timeFrame: End-of-Treatment (single administration at Treatment Week 12)
measure: Peer Coach Fidelity Across Treatment Sessions
timeFrame: Calculated at End-of-Treatment (Treatment Week 12)
measure: Coaching Session Completion
timeFrame: Calculated at End-of-Treatment (Treatment Week 12)
measure: Treatment Session Completion
timeFrame: Calculated at End-of-Treatment (Treatment Week 12)
measure: Peer Coaching Satisfaction
timeFrame: End-of-Treatment (single administration at Treatment Week 12)
measure: Treatment Satisfaction
timeFrame: End-of-Treatment (single administration at Treatment Week 12)
measure: Drop Out Status
timeFrame: Calculated at End-of-Treatment (Treatment Week 12)
measure: Homework Completion
timeFrame: Calculated at End-of-Treatment (Treatment Week 12)
Secondary outcomes:
measure: Change from Baseline on EES-2 Total Score at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on DERS Total Score at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on CBCL Total Problem Behaviors at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on CDI-Words and Gestures at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on CSHQ at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on Albany Sleep Problems scale at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on ZBI-7 at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on ABC-2 at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on MIBI at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change from Baseline on PCL-5 at End-of-Treatment Survey
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
Other outcomes:
measure: Change in Daily Reports of Health Behaviors between Baseline and End-of-Treatment
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change in Daily Reports of Caregiver Sleep between Baseline and End-of-Treatment
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change in Momentary Self-Efficacy between Baseline and End-of-Treatment
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
measure: Change in Daily Reports of Child Challenging Behaviors between Baseline and End-of-Treatment
timeFrame: Baseline and End-of-Treatment (Treatment Week 12)
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Bridgette Kelleher, PhD
role: PRINCIPAL_INVESTIGATOR
References: