Home-Based Interventions for Adolescents With Type 1 Diabetes (R34)

May 31, 2017 updated by: Deborah Ellis, Ph.D., Wayne State University

Translating Home-Based Interventions for Adolescents With Poorly Controlled TID

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Control: Hemoglobin A1c (HbA1c)
Time Frame: Change from Baseline at 7 months, Change from Baseline at 9 months
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)
Time Frame: Change from Baseline at 7 months, Change from Baseline at 9 months
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
Time Frame: Change from Baseline at 7 months, Change from Baseline at 9 months
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
Time Frame: Change from Baseline at 7 months, Change from Baseline at 9 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

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

Investigators

  • Principal Investigator: Deborah A Ellis, Ph.D, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34DK102091-01 (U.S. NIH Grant/Contract)
  • R34DK102091 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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