NCT03812614Completed
Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
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 (I-DSMES).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 444 (actual)
- First submitted
- 18 Jan 2019
- Start date
- 23 Sept 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Pittsburgh
- Diseases
- High blood pressure
- NCT number
- NCT03812614
What you commit to
- Study type: Interventional
- Participants enrolled: 444
- From 23 Sept 2019 to the primary completion date, 31 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patient Inclusion Criteria:
- 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 Criteria:
- 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 Exclusion Criteria:
- Does not speak English or Spanish
- Receives pay for caring for the patient
- Has self-reported serious mental illness (schizophrenia)
- Has a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
- Has significant cognitive impairment (Alzheimer's disease or dementia)
- Lives in a nursing home or long-term care facility
- Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Community Health and Social Services Center (CHASS) Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
Related publications
- Transition to Virtual Diabetes Self-Management Education Delivery in the Setting of Health Care Disruption for Adults With Diabetes and Their Support Persons.Sci Diabetes Self Manag Care · 2026 · PMID 41958056
This page is information, not medical advice. Discuss any trial with your doctor.