Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of Families Consented Versus Approached
研究概览
简要总结
The goal of this clinical trial is to learn if the REAL-Fam occupational therapy intervention is feasible to study in a larger-scale randomized controlled trial. It will also seek to understand how the intervention influences how a rural family participates in and manages their child's type 1 diabetes, their family quality of life, and the child's health outcomes. The main questions it aims to answer are:
- Primary Aim 1: Evaluate the recruitment capability, participant inclusion criteria, assessment selection and process, and data.
- Primary Aim 2: Evaluate the participant acceptability of and interventionist fidelity to the intervention.
- Secondary Aim: Evaluate families' preliminary outcomes to the REAL-Fam on family quality of life and participation, diabetes management self-efficacy, and child blood glucose stability.
Researchers will compare the REAL-Fam intervention to the Attention Group to see if there are changes in family diabetes-related health routines and psychosocial aspects of managing a child's type 1 diabetes.
Participants will:
- Children will wear continuous glucose monitors for study period
- Caregiver participants will complete baseline and post-intervention surveys
- Intervention Group: engage in 12 audio/video telehealth sessions with REAL-Fam intervention
- Attention Group: engage in 3 audio/video Zoom meetings without specialized services
- Complete a post-study interview
详细描述
The prevalence of type 1 diabetes (T1D) is increasing among youth in the U.S., with higher incidence rates documented in rural communities compared to their urban peers. This rise is especially concerning for rural families, because they are at risk for healthcare disparities resulting from transportation challenges, lack of healthcare access, decreased financial stability, and other social determinants of health. The Resilient Empowered Active Living for Families (REAL-Fam) occupational therapy telehealth intervention provides a practical, immediate solution to increase access to low-cost, quality healthcare services for rural-dwelling caregivers and children living with T1D. Utilizing community-engaged research methods, this randomized clinical trial with follow-up interviews examines the feasibility of the 12-week REAL-Fam intervention group (n=8 dyads) compared to an attention group (n=8 dyads) for rural-dwelling caregiver/child dyads to improve the a) caregivers' diabetes management self-efficacy, b) caregivers' quality of life, and the c) children's glycemic levels. The REAL-Fam is innovative because it will extend diabetes care beyond glucose monitoring to include culturally sensitive healthcare experiences, family-centered behavioral interventions, healthy habit and routine training, and school and childcare participation strategies within the scope of occupational therapy. The successful evaluation of the REAL-Fam is critical to evaluate the protocol and support a full-scale clinical trial, which may inform other historically underrepresented socio-demographic groups that may not have access to ongoing diabetes healthcare services.
The findings from this study will inform healthcare practitioners, patients, and other stakeholders of the needs of rural families who are caring for a child with T1D and their urgent healthcare needs, such as improving quality of life and increasing access to specialized healthcare services. From the interdisciplinary team's past research focusing on T1D stakeholder needs in rural communities, it was apparent that many caregivers reported a need to access specialized diabetes care quicker after their child's diagnosis, which without this access they experienced poor health outcomes. Overall, successful evaluation of the REAL-Fam telehealth intervention is an important, necessary step to support future studies that may contribute to the advancement of T1D healthcare practices and improved child health outcomes for rural dwelling families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician who is performing randomization and statistical analysis of data will be blinded to which arm of the study to which a participant was selected.
入排标准
- 年龄范围
- 2 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregiver over 19 years old and designated guardian or parent to a child living with Type 1 Diabetes;
- •Live in a rural area over 1 hour from pediatric endocrinology care team;
- •Access to reliable internet
排除标准
- •Caregiver who is not completing any supervision/support for their child's diabetes management;
- •If the child is currently receiving occupational therapy services;
- •Has a severe developmental, intellectual, or neurological disability
研究组 & 干预措施
Attention Group
8 caregiver-child dyads will receive 3 attention group sessions with a research team member and engage in activities such as creating music play lists, playing games, and having conversation without specialized healthcare services.
REAL-Fam Intervention Group
8 caregiver-child dyads will receive the Resilient, Empowered, Active Living for Families intervention. This is an occupational therapy family coaching intervention, which will be delivered via 12 weekly telehealth sessions.
干预措施: REAL-Fam Occupational Therapy Family Coaching (Behavioral)
结局指标
主要结局
Percentage of Families Consented Versus Approached
时间窗: 12-week post treatment initiation
One feasibility measure was to evaluate the number and percentage of families consented compared to those approached for participation in the study.
Number and Percentage of Standard of Care Condition Participants Retained vs Enrolled
时间窗: 12-week post treatment initiation
Number and Percentage of standard of care condition participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.
Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled
时间窗: 12-week post treatment initiation
Number and Percentage of Intervention Group participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.
Number and Percentage of Surveys Completed by Participants Who Completed the Study
时间窗: 12-week post treatment initiation
Number and Percentage of surveys over time completed by participants who completed the study.
Number and Percentage of attendance at telehealth sessions
时间窗: 12-week post treatment initiation
The total number/amount of sessions attended out of the total number of sessions available, reported as both the total number and the percentage.
Number and percentage of dyads enrolled for the different recruitment strategies
时间窗: 12-week post treatment initiation
For each recruitment strategy, the researchers will document the total number and percentage of how many families were eligible, approached, and enrolled
Telehealth Satisfaction Survey
时间窗: 12-week post treatment initiation
A self-reported questionnaire for caregivers to rate how satisfied they were with the telehealth sessions (a measure of study acceptability). It includes 10 questions with 1-4 ratings, with higher scores indicating higher levels of satisfaction.
Training Satisfaction Rating Scale
时间窗: 12-week post treatment initiation
A self-reported questionnaire for caregivers to rate their satisfaction with the REAL-Fam intervention. It includes the following subdomains: Objectives and content (3 questions); Method of training context (6 questions); Usefulness and overall rating (3 questions). Items are rated on a 1-5 scale, with higher scores indicating higher levels of acceptability.
Study Specific Interview Guide
时间窗: 12-week post treatment initiation
A semi-structured interview guide to qualitatively assess feasibility and acceptability of the REAL-Fam intervention framework. It includes questions related to recruitment and enrollment (3 questions); scheduling and time commitment (3 questions); assessments and data collection (3 questions); technology use (2 questions); overall burden/ease (2 questions); perceived value of the intervention ( 2 questions); engagement and enjoyment (2 questions); format delivery (2 questions); relevance to family's life (2 questions); therapist interaction (2 questions); rural context (2 questions); modules and content (3 questions); habit \& routine focus of the intervention (3 questions); perceived changes/impact (2 questions); recommendations for improvement (2 questions); and overall reflections (2 questions). Qualitative results will be reported by each sub-domain.
次要结局
- WHO Quality of Life, Brief (WHOQOL-BREF)(Baseline and 12-week post treatment initiation)
- Diabetes Health Management Performance Scale - Parents of Children(Baseline and 12-week post treatment initiation)
- Problem Areas in Diabetes - Parents of Children(Baseline and 12-week post treatment initiation)
- Diabetes Family Conflict Scale - Revised(Baseline and 12-week post treatment initiation)
- Self-Efficacy for Diabetes Scale (MSED)(Baseline and 12-week post treatment initiation)