Home-Based Interventions for Adolescents With Type 1 Diabetes

NCT ID: NCT02243072

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-07-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fit Familes plus Standard Medical Care

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.

Group Type: EXPERIMENTAL

Fit Families plus Standard Medical Care

Intervention Type: BEHAVIORAL

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

Standard Medical Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fit Families plus Standard Medical Care

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Deborah Ellis, Ph.D.

Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah A Ellis, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Children's Hospital of Michigan

Detroit, Michigan, United States

Countries

United States

Other Identifiers

R34DK102091

Identifier Type: NIH

Identifier Source: secondary_id

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1R34DK102091-01

Identifier Type: NIH

Identifier Source: org_study_id

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