NCT02243072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 2, 2017

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

September 4, 2014

Last Update Submit

May 31, 2017

Conditions

Type 1 Diabetes

Keywords

Insulin Dependent Diabetes Mellitusfamily therapyadolescentsregimen adherencemetabolic control

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)

    Change from Baseline at 7 months, Change from Baseline at 9 months

  • Quality of life

    Change from Baseline at 7 months, Change from Baseline at 9 months

  • Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads

    Change from Baseline at 7 months, Change from Baseline at 9 months

Study Arms (2)

Fit Familes plus Standard Medical Care

EXPERIMENTAL

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

Standard Medical Care

NO INTERVENTION

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.

Interventions

Fit Families plus Standard Medical CareBEHAVIORAL

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

Fit Familes plus Standard Medical Care

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Deborah A Ellis, Ph.D

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 17, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

June 2, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)