Reducing heart disease risk in diabetes patients
Improving Diabetic Patients' Adherence to Treatment and Prevention of Cardiovascular Disease
This study is testing if a new program that combines patient support with text messages can help people with Type 2 diabetes stick to their medications and lower their risk of heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 378 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Michigan State University Academic / other |
| Locations | 1 site (Lansing, Michigan) |
| Trial ID | NCT04874116 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a patient activation program called Office Guidelines Applied to Practice (Office-GAP) combined with mobile text messaging reinforcement (Way to Health) in improving health outcomes for patients with Type 2 diabetes. Conducted in Federally Qualified Health Centers (FQHCs) in Michigan, the study will randomly assign diabetes patients to either an intervention group that receives both Office-GAP and text messaging or a control group that receives only text messaging. The aim is to enhance medication adherence and reduce cardiovascular disease complications among low-income and minority populations.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with Type 2 diabetes and an HbA1c greater than 8 who are taking prescribed medications for blood pressure or cholesterol management.
Not a fit: Patients with cognitive impairments, dementia, or psychosis, or those planning to leave the area before study completion, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve medication adherence and reduce cardiovascular risks for patients with diabetes.
How similar studies have performed: Previous studies have shown promise in using patient-centered communication strategies to improve health outcomes, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients: aged \>18 at participating Federally Qualified Health Care centers (FQHCs) and; 1) have a diagnosis of Type 2 diabetes (T2DM) with HbA1c \>8, with or without CVD; 2) patient should be taking at least one prescribed medication for BP or cholesterol management 3) able to provide informed consent 4) able to read and speak English (grade 6 reading level); 5) have a cell phone with texting (provided by our study for any enrolled patient who does not have one). Exclusion Criteria: 1) medical record documentation of cognitive impairment, dementia or psychosis 2) plans to leave the area prior to study completion 3) participating in another cellphone program.
Where this trial is running
Lansing, Michigan
- Ingham Healthcare center — Lansing, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Adesuwa Olomu, MD, MS — Michigan State University
- Study coordinator: Adesuwa Olomu, MD, MS
- Email: olomua@msu.edu
- Phone: 517-432-0897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.