Clinical trial NCT02243072: Home-Based Interventions for Adolescents With Type 1 Diabetes
Official title: Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Insulin Dependent Diabetes Mellitus
family therapy
adolescents
regimen adherence
metabolic control
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-09-17
Enrollment: 49
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic Control: Hemoglobin A1c (HbA1c)
timeFrame: 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)
timeFrame: Change from Baseline at 7 months, Change from Baseline at 9 months
measure: Quality of life
timeFrame: Change from Baseline at 7 months, Change from Baseline at 9 months
measure: Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
timeFrame: Change from Baseline at 7 months, Change from Baseline at 9 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
Study officials:
affiliation: Wayne State University
name: Deborah A Ellis, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: