Tailored Diabetes Self-Management Resources

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Family-Centered Tailoring of Pediatric Diabetes Self-Management Resources

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024750
• Other study ID #: 2013-1506
• Secondary ID: MSN164403IRB 000
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: August 8, 2017

Study information

• Verified date: September 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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)

• Participant in prior preliminary work for this study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention	Mean change in A1c per month (slope), during and post-intervention.	Up to 5 time points during the intervention (12 months) and up to 4 time points in the post-intervention period (12 months)
Primary	Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention	Mean change in child quality of life per month (slope), during and post-intervention. Child quality of life is measured by the PedsQL Diabetes Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life.	Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)
Primary	Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention	Mean change in parent quality of life per month (slope), during and post-intervention. Parent quality of life is measured by the PedsQL Family Impact Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life.	Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)
Secondary	Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention	Mean change in parent fear of hypoglycemia per month (slope), during and post-intervention. Parent fear of hypoglycemia is measured by the Hypoglycemia Fear Survey Worry Subscale. Possible scores range from 15 to 75 with higher scores indicating greater fear of hypoglycemia. Positive slopes reflect increasing fear of hypoglycemia.	Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months)