Tailored Diabetes Self-Management Resources

NCT02024750 | Completed Results

• 3 other identifiers: 2013-1506MSN164403IRB 00016300
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Family centered care; Patient centered care; Diabetes Mellitus, Type 1; Problem Recognition in Illness Self-Management (PRISM)

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention

  Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months)

Study Arms (2)

Tailored Resources

EXPERIMENTAL

Use of PRISM screening tool to identify self-management needs and to provide tailored group session resources over 1 year

Behavioral: Tailored Resources

Usual Care

NO INTERVENTION

Patients and families obtain routine multidisciplinary diabetes care

Interventions

Tailored Resources BEHAVIORAL

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.

Tailored Resources

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Newly diagnosed with diabetes (\< 12 months)
• Participant in prior preliminary work for this study

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Medical College of Wisconsin: collaborator

Study Sites (2)

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (2)

• Fiallo-Scharer R, Palta M, Chewning BA, Rajamanickam V, Wysocki T, Wetterneck TB, Cox ED. Impact of family-centered tailoring of pediatric diabetes self-management resources. Pediatr Diabetes. 2019 Nov;20(7):1016-1024. doi: 10.1111/pedi.12899. Epub 2019 Aug 8.

  PMID: 31355957 DERIVED

• Fiallo-Scharer R, Palta M, Chewning BA, Wysocki T, Wetterneck TB, Cox ED. Design and baseline data from a PCORI-funded randomized controlled trial of family-centered tailoring of diabetes self-management resources. Contemp Clin Trials. 2017 Jul;58:58-65. doi: 10.1016/j.cct.2017.04.007. Epub 2017 Apr 24.

  PMID: 28450194 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Elizabeth Cox
• Organization: University of Wisconsin School of Medicine and Public Health

ecox@wisc.edu

608-263-9104

Study Officials

• Elizabeth D Cox, MD,PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: September 1, 2014
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: September 18, 2019
• Results First Posted: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)