Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatment diabetes strengths study
Sponsor Baylor College of Medicine
Collaborator Texas Children's Hospital
Start date July 2014
End date September 2016
Trial size 84 participants
Trial identifier NCT02510664, 1K12DK097696, H-34857

Summary

The purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes. The intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
There is no control/comparator group for this pilot study - all participants receive the intervention
diabetes strengths study
The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments.

Primary Outcomes

Measure
Feasibility
time frame: 6-8 months after intervention begins (immediately following second study visit)
Acceptability
time frame: 6-8 months after intervention begins (immediately following second study visit)

Secondary Outcomes

Measure
Diabetes regimen adherence
time frame: Baseline, 3-4 months (second study visit), and 6-8 months after intervention begins (immediately following second study visit)
Glycemic control
time frame: Baseline, 3-4 months (second study visit), and 6-8 months after intervention begins (immediately following second study visit)
Diabetes Burden
time frame: Baseline and 6-8 months after intervention begins (immediately following second study visit)
Diabetes-related Family Conflict
time frame: Baseline and 6-8 months after intervention begins (immediately following second study visit)
Healthcare Satisfaction
time frame: Baseline and 6-8 months after intervention begins (immediately following second study visit)
Diabetes Strengths
time frame: Baseline, 3-4 months (second study visit), and 6-8 months after intervention begins (immediately following second study visit)

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

Inclusion Criteria: 1. At least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. When present, secondary caregivers involved in diabetes management will be invited (not required) to participate. 2. Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management 3. Youth and parent fluency in written and spoken English because assessment measures are not available in other languages. Exclusion Criteria: (1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.

Additional Information

Official title Promoting Resilience in Youth With Type 1 Diabetes: Pilot of Strengths-Based Family Intervention to Improve Diabetes Outcomes (Diabetes Strengths Study)
Description The purpose of this study is to pilot test a newly developed strengths-based clinical intervention delivered by diabetes care providers in the context of routine ambulatory diabetes care, designed to promote resilience and support diabetes management among adolescents with type 1 diabetes and their families. The emphasis of the intervention is shifting the tone of clinical encounters for diabetes care to emphasize and reinforce youths' and families' current diabetes strengths and positive diabetes management behaviors. Youth with type 1 diabetes are seen routinely in clinic every 3-4 months, and this intervention will occur at two consecutive clinic visits. The intervention consists of (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments. Outcome assessments are conducted at baseline (prior to the start of the intervention) and immediately following the conclusion of the intervention (approximately 6-8 months later). The primary outcome is feasibility and acceptability, measured by qualitative feedback from participants and providers, as well as quantification of recruitment and enrollment, provider adherence to intervention protocol, and time to completion. Secondary (exploratory) outcomes include diabetes regimen adherence, glycemic control, family conflict, diabetes burden, diabetes strengths, and satisfaction with the diabetes care provider relationship. Strengths and adherence assessments are also completed prior to the second clinic visit to generate the diabetes strengths profile.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.