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Completed

NCT Number: NCT02243072

Home-Based Interventions for Adolescents With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fit Families plus Standard Medical Care

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

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

Registry information

Official study title

Translating Home-Based Interventions for Adolescents With Poorly Controlled TID

Acronym: R34

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 17, 2014
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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