Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatment tailored resources
Sponsor University of Wisconsin, Madison
Collaborator Medical College of Wisconsin
Start date September 2014
End date July 2017
Trial size 214 participants
Trial identifier NCT02024750, 2013-1506, IRB 00016300, MSN164403

Summary

Children with type 1 diabetes face complex self-management regimens which make adherence challenging and ultimately result in poor blood sugar control. Several common barriers interfere with diabetes control such as limited knowledge or challenges with staying motivated. Efficacious strategies exist to improve diabetes self-management including, but not limited to, diabetes education or family therapy. Patients and families often do not access these strategies, in part due to healthcare systems-based issues such as accessibility, provider availability, or insurance coverage.

A family-centered approach has been suggested to tailor diabetes care to provide improved outcomes for each child. Family-centered care engages the family in the decision-making about the child's health and well-being. In this study we will take a family-centered approach to providing diabetes self-management by identifying families' unique self-management barriers through a 10-minute survey tool called PRISM (Problem Recognition in Illness Self-Management). Based upon the results of PRISM, we will provide tailored self-management resources (interventions) to meet the family's needs. We will coordinate group-based delivery of the resources with routine diabetes clinic visits. These group-based resources will be delivered in four 75-minute sessions over a year.

The primary goal of this study is to compare the effectiveness of family-centered tailoring of diabetes self-management resources with the untailored approach of usual care. We hypothesize that the family-centered model of care with tailored resources will improve the outcomes of glycemic control and quality of life among children with type 1 diabetes and their parents.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Use of PRISM screening tool to identify self-management needs and to provide tailored group session resources over 1 year
tailored resources
Based upon PRISM screening tool results that identifies self-management barriers, patient/family will receive self-management resources matched to their barriers. These resources could be focused on: 1. Understanding and organizing care; 2. Motivation to self-manage; and 3. Family Teamwork. Group session of about 6 families with the same barrier will meet four times fo 75-minutes over a year, at the clinic site on same date as routine clinic visit.
(No Intervention)
Patients and families obtain routine multidisciplinary diabetes care

Primary Outcomes

Measure
Change in Hemoglobin A1c
time frame: Seven time points: quarterly during trial and every 6 months during the post-trial year

Secondary Outcomes

Measure
Quality of Life for youth
time frame: Five time points: at baseline and every 6 months during the trial year and post-trial year.
Quality of Life for parent
time frame: Five time points: at baseline and every 6 months during the trial year and post-trial year.

Eligibility Criteria

Male or female participants from 8 years up to 16 years old.

Inclusion Criteria: - Children and adolescents with type 1 diabetes and their parents who receive care at one of two sites in Wisconsin. - Planning to continue care at clinic for the next 2 years. - English speaking - Diagnosed with diabetes for > 12 months Exclusion Criteria: - Newly diagnosed with diabetes (< 12 months) - Not a participant in prior preliminary work for this study

Additional Information

Official title Family-Centered Tailoring of Pediatric Diabetes Self-Management Resources
Principal investigator Elizabeth D Cox, MD,PhD
Description This project's long-term goal is to develop a system-level method to move existing, efficacious self-management resources into the hands of children with type 1 diabetes and their families. Over 175,000 US children have type 1 diabetes and face a lifetime of self-management decisions in an attempt to delay or prevent complications, avoid hypoglycemia, and maintain quality of life for themselves and their parents. Although efficacious self-management resources exist, most children with diabetes struggle to manage their disease. Several barriers to diabetes management exist, including knowledge, motivation, and family interactions. Because barriers are unique for each child and family, family-centered approaches are recommended. Currently, no systematic approach exists to identify and address each family's self-management barriers. Information from PRISM (Problem Recognition in Illness Self-Management), a 10-minute survey tool, could help families and clinicians make better decisions to address these barriers, ultimately improving outcomes, fostering family-centered diabetes care, and optimizing resource use. This randomized, pragmatic trial will compare outcomes from PRISM-based, family-centered tailoring of self-management resources (intervention) to outcomes from the untailored approach of usual care. Our specific aims are to assess the effect of family-centered tailoring of diabetes self-management resources on outcomes that matter to the children and parents: glycemic control (A1c and fear of hypoglycemia) and child and parent quality of life. Children 8-16 years old with diabetes (150 each in usual care and intervention groups) and their parents will be enrolled at two large pediatric diabetes clinics. We will 1) use PRISM to identify families' unique self-management barriers; 2) tailor self-management resources to identified barriers; and 3) coordinate group-based delivery of the resources with routine diabetes visits. The group-based resources will be delivered in four 75-minute sessions over 12 months. A1c will be assessed after sessions, along with fear of hypoglycemia and quality of life for the child and parent. We will compare outcomes with mixed-effects models.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.