Status:
COMPLETED
Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
The Community Health and Social Services Center, Inc.
University of Michigan
Conditions:
Diabetes Mellitus
High Blood Pressure
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support...
Detailed Description
FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs): 1. coach family supporters in regular discussions about AWDs' ...
Eligibility Criteria
Inclusion
- Patient
- Have a diagnosis of Type 2 diabetes
- Most recent HbA1c done in the 3 months prior to screening phone call \>= 7.5%
- Plan to use recruiting site for health care over the next 12 months after enrollment
- Must be able to identify a family member or friend who is willing to be involved in their health care
- Patient
Exclusion
- Diagnosis (active or prior) of Alzheimer's disease or dementia
- Preferred language is not English or Spanish
- Diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder in CHASS EMR Problem list as of screening call date
- Diagnosis of gestational diabetes without any other diabetes diagnoses
- Diagnosed with diabetes at age \< 21 years
- Pregnant or planning to become pregnant in the next 12 months
- Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
- Have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
- Support Person Inclusion Criteria:
- Able to attend intervention sessions in person or remotely via online video-conferencing
- At least 21 years old
- Support Person
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT03812614
Start Date
September 23 2019
End Date
December 31 2023
Last Update
February 13 2025
Active Locations (2)
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1
Community Health and Social Services Center (CHASS)
Detroit, Michigan, United States, 48209
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213