Home-Based Interventions for Adolescents With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Translating Home-Based Interventions for Adolescents With Poorly Controlled TID

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Fit Families plus Standard Medical Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fit Familes plus Standard Medical Care<br>Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care. | Behavioral: Fit Families plus Standard Medical Care<br>* Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months<br>|
| No Intervention: Standard Medical Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control: Hemoglobin A1c (HbA1c) | retrospective measure of blood glucose control, encompasses the previous 2-3 months | Change from Baseline at 7 months, Change from Baseline at 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ) | The number of patient visits to acute care settings represents a significant health care cost in this high-risk population. | Change from Baseline at 7 months, Change from Baseline at 9 months | 
| Quality of life | 44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents. | Change from Baseline at 7 months, Change from Baseline at 9 months | 
| Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads | The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control | Change from Baseline at 7 months, Change from Baseline at 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Dependent Diabetes Mellitus, family therapy, adolescents, regimen adherence, metabolic control