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N/A N=214 Randomized Single-blind Treatment

Tailored Diabetes Self-Management Resources

Diabetes Mellitus, Type 1

Enrolled (actual)
214
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention — 0.014; 0.018; 0.035; 0.025 Percent HbA1c per month — p=0.72

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tailored Resources (Behavioral)
Age
Pediatric · 8+ yrs
Sex
All
Sponsor
University of Wisconsin, Madison
Primary completion
Aug 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
0.014; 0.018; 0.035; 0.025 0.72
PRIMARY
Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
0.194; 0.217; 0.083; 0.010 0.87
PRIMARY
Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
0.115; 0.078; 0.182; 0.172 0.79
SECONDARY
Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
-0.088; 0.046; -0.074; -0.080 0.30

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02024750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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