NCT Number: NCT07212790
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
Interested in participating?
Request Info2 year–99 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27514, United States
Location status: Recruiting
Amy Thompson, MS
SUB_INVESTIGATOR
Emily Knezevich, PharmD
SUB_INVESTIGATOR
Julia Shin, EdD
SUB_INVESTIGATOR
Nina Jain, MD
SUB_INVESTIGATOR
Sabrina Zadrozny, PhD
SUB_INVESTIGATOR
Shelley Newpher, MA
CONTACT
Vanessa Jewell, PhD
CONTACT
Vanessa Jewell, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The REAL-Fam draws on the expertise of occupational therapy in evaluating the fit between the demands of everyday activities and the skills and abilities of the parent-child dyads. The dyad and the occupational therapist will be equipped to co-develop personalized strategies to enable participation in these meaningful occupations. It facilitates the family's consistent, habitual, and effective performance of their child's diabetes management tasks into their personalized daily routines. Emphasis is on the creation or modification of family-centered diabetes management and routines and catered to the child's developmental needs. Due to the complexity of diabetes management cares and the child's age, the caregiver will be present for all sessions. When working towards a caregiver-centered outcome, the caregiver will participate with little child involvement. When working toward a child-centered outcome, the child will be the focus of that session.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-week post treatment initiation
Number and Percentage of surveys over time completed by participants who completed the study.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12-week post treatment initiation
Self-reported quality of life; higher score = better quality of life. The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. In addition, there are 2 items that measure overall QOL and general health. Subscales (domains): Physical Health (7 items) Psychological Health (6 items) Social Relationships (3 items) Environment (8 items) Scoring: Items scored 1-5. Raw domain score is the sum of respective item scores. All domain scores are then normalized to a range of 0-100. Results reported by each sub-domain and by total score.
Time frame: Baseline and 12-week post treatment initiation
Self-reported performance in various diabetes health management tasks; higher score = higher level of performance with diabetes self management. Includes two parts to the assessment. Part A has the caregiver rate their performance in each category from the past 3 months. There are 5 subdomains: Diabetes Self-Management, (6 questions); Nutrition (2 questions); Physical Activity & Exercise (2 questions); School and Childcare (3 questions); and Lifestyle Management (12 questions). Part B has the caregiver rate their child's performance in the following subdomains: Diabetes Self-Management (5 questions); Nutrition (2 questions); Physical Activity and Exercise (2 questions); School and Childcare (1 question); and Lifestyle Management (3 questions). Results reported by each subdomain.
Time frame: Baseline and 12-week post treatment initiation
A self-reported questionnaire for caregivers to report any potential difficulties with managing their child's diabetes cares. It includes 16 questions, with a rating of 1-6, with higher scores indicating a more serious problem with managing their child's diabetes. Results reported as one total score.
Time frame: Baseline and 12-week post treatment initiation
A self-reported questionnaire for caregivers to report any potential family conflicts with managing their child's diabetes' cares. It includes 19 questions, with a 1-3 rating, and higher ratings indicating more family conflict.
Time frame: Baseline and 12-week post treatment initiation
A self-reported questionnaire for caregivers to report their confidence with managing their child's diabetes self-cares. Includes 17 questions, on a 1-5 rating, with higher scores indicating higher levels of confidence in completing diabetes self management.
University of North Carolina, Chapel Hill
Other
Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health
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