Overview

This trial has been completed.

Condition type 1 diabetes
Treatments fit families plus standard medical care, standard medical care
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date December 2014
End date December 2015
Trial size 49 participants
Trial identifier NCT02243072, 1R34DK102091-01

Summary

Adolescents with T1D and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. The purpose of the proposed study is to collaborate with a community agency to develop and test an intervention, Fit Families, that uses the core components of a previously successful home-based family treatment, but that can delivered by lower cost community health workers. If successful, Fit Families could improve health outcomes in a vulnerable population at high risk for diabetes complications, and could be translated to real-world treatment settings.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs)
fit families plus standard medical care
Adolescents will receive twice weekly home-based, family psychotherapy from a CHW for 6 months
(Active Comparator)
Treatment is provided as usual by patient's diabetes medical team.
standard medical care Treatment As Usual
Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.

Primary Outcomes

Measure
Metabolic Control: Hemoglobin A1c (HbA1c)
time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
time frame: Change from Baseline at 7 months, Change from Baseline at 9 months

Secondary Outcomes

Measure
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
Quality of life
time frame: Change from Baseline at 7 months, Change from Baseline at 9 months

Eligibility Criteria

Male or female participants from 10 years up to 17 years old.

Inclusion Criteria: - a current hemoglobin A1c(HbA1c) of >9.0% - an average HbA1c of >9.0% during the past year - reside in the metro Detroit tri-county area - diagnosed with Type 1 diabetes for at least one year - aged 10-17 - patient of Children's Hospital of Michigan Diabetes Clinic Exclusion Criteria: - severe mental impairment/thought disorder - Active suicidality - Active homicidality - Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.

Additional Information

Official title Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
Principal investigator Deborah A Ellis, Ph.D
Description The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial. The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).