Optimizing a Personalized Health Approach for Virtually Treating High-risk Caregivers During COVID-19 and Beyond
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Change from Baseline on CGI-S at End-of-Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Care providers will be masked to the status of peer coaching and algorithm assignment. Peer coaches will be masked to the status of algorithm assignment. Data managers and statisticians evaluating study outcomes will be provided de-identified data and will not be involved in treatment-related study operations.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change from Baseline on CGI-S at End-of-Treatment
时间窗: Baseline and End-of-Treatment (Treatment Week 12)
The Clinical Global Impression-Severity (CGI-S) is rated by the patient's primary clinician on a scale of 1-7, with higher scores indicating greater impairment. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Clinical Global Impression-Improvement (CGI-I) at End-of-Treatment
时间窗: End-of-Treatment (single administration at Treatment Week 12)
The Clinical Global Impression-Improvement (CGI-S) is rated by the patient's primary clinician on a scale of 1-7, with higher scores indicating greater impairment. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Peer Coach Fidelity Across Treatment Sessions
时间窗: Calculated at End-of-Treatment (Treatment Week 12)
Fidelity will be observer-rated by reliable coders to generate a fidelity ratio (0-100%), defined as the proportion of pre-defined critical session components administered to "acceptable" criterion; higher ratios indicate greater fidelity. The total fidelity score for each patient is calculated as the average of completed Baseline, Midpoint, and End-of-Treatment sessions.
Homework Completion
时间窗: Calculated at End-of-Treatment (Treatment Week 12)
Completion will be reported by clinicians to generate a completion ratio (0-100%), defined as the proportion of assigned session homework completed; higher ratios indicate greater completion. Participants in the self-guided resource condition will self-report completion across 12 weeks of tasks using a log submitted at end of treatment.
Change from Baseline on PSOC Total Score at End-of-Treatment Survey
时间窗: Baseline and End-of-Treatment (Treatment Week 12)
The patient-reported Parenting Sense of Competence Total Score includes ranges from 17-102; higher scores indicate greater parenting sense of competency. Wording was adapted from the original 1978 measure to be inclusive of caregivers who are not biological parents or mothers. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
Change in Average PANAS Negative Affect between Baseline and End-of-Treatment
时间窗: Baseline and End-of-Treatment (Treatment Week 12)
The patient-reported Positive and Negative Affect Scale (10 items) Negative Affect subscale total score ranges from 10-50; higher scores indicate greater negative affect. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Change from Baseline on DASS-21 Total-Score at End-of-Treatment Survey
时间窗: Baseline and End-of-Treatment (Treatment Week 12)
The patient-reported Depression, Anxiety, and Stress Scale, 21 Total Score ranges from 0-63; higher scores indicate greater impairment. Change is measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Change from Baseline on PSI-4-SF Total Score at End-of-Treatment Survey
时间窗: Baseline and End-of-Treatment (Treatment Week 12)
The patient-reported Parenting Stress Index, 4th Edition (PSI-4-SF) Total T-Score ranges from 0-100; higher scores indicate greater stress. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
Drop Out Status
时间窗: Calculated at End-of-Treatment (Treatment Week 12)
"Drop out" is defined as discontinuation of treatment after consenting to treatment and attending at least one session, including active discontinuation and patients lost to follow-up. Variable is dummy coded where 0=patient did not drop out, 1=patient dropped out.
Change in Average Momentary Stress between Baseline and End-of-Treatment
时间窗: Baseline and End-of-Treatment (Treatment Week 12)
The patient-reported momentary stress item ranges from 0-100; higher scores indicate greater stress. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Coaching Session Completion
时间窗: Calculated at End-of-Treatment (Treatment Week 12)
Completion will be reported by project staff and used to generate a completion ratio (0-100%), defined as the proportion of sessions attended; higher ratios indicate greater completion.
Peer Coaching Satisfaction
时间窗: End-of-Treatment (single administration at Treatment Week 12)
Patient-reported peer coaching satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.
Treatment Session Completion
时间窗: Calculated at End-of-Treatment (Treatment Week 12)
Completion will be reported by clinicians to generate a completion ratio (0-100%), defined as the proportion of sessions attended; higher ratios indicate greater completion. Participants in the self-guided resource condition will self-report completion across 12 weeks of tasks using a log submitted at end of treatment.
Treatment Satisfaction
时间窗: End-of-Treatment (single administration at Treatment Week 12)
Patient-reported treatment satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.
次要结局
- Change from Baseline on CBCL Total Problem Behaviors at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on Albany Sleep Problems scale at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on EES-2 Total Score at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on DERS Total Score at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on CDI-Words and Gestures at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on CSHQ at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on ZBI-7 at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on PCL-5 at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on ABC-2 at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
- Change from Baseline on MIBI at End-of-Treatment Survey(Baseline and End-of-Treatment (Treatment Week 12))
研究者
KelleherLab
Associate Professor
Purdue University