Type 1 Diabetes Clinical Trial
— R34Official title:
Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
Verified date | November 2016 |
Source | Wayne State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Michigan | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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 |
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