Home-Based Interventions for Adolescents With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— R34  

Official title:

Translating Home-Based Interventions for Adolescents With Poorly Controlled TID

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243072
• Other study ID #: 1R34DK102091-01
• Secondary ID: R34DK102091
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: May 31, 2017
• Start date: December 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Michigan	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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