N/A
Completed N=1,085
Comparative Effectiveness of Diabetes Shared Medical Appointment Models
Source: ClinicalTrials.gov NCT03590041 ↗Enrolled (actual)
1,085
Serious AEs
—
Results posted
Apr 2025
Primary outcomePrimary: Diabetes Distress - Change in Patient Reported Outcomes (PROs) — 1.9; 1.9 score on a scale — p=0.04
Summary
In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diabetes Distress - Change in Patient Reported Outcomes (PROs) |
1.9; 1.9 | 0.04 sig |
| SECONDARY Change in Patient HbA1c |
7.8; 7.9 | 0.82 |
Eligibility Criteria
Inclusion Criteria
- Patients must be:
- at least 18 years old,
- have Type II Diabetes, and
- receive care in a participating practice.
- For a practice to be eligible, they must be;
- a Federally Qualified Health Center,
- a private primary care practice, or
- Community Mental Health Center with primary care,
- They need to have
- a current panel of at least 150 adult patients with Type 2 Diabetes, and
- access to health educators, Behavioral Health Professionals, and diabetes peer mentors.
Exclusion Criteria
- Are currently pregnant or plan to become pregnant in the next six months,
- Have limited cognitive ability due to dementia or a developmental disorder,
- Less than one year of life expectancy, or
- Plan to leave the area in the next year.
Data sourced from ClinicalTrials.gov (NCT03590041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.