Improving diabetes outcomes through financial support and peer assistance
Pilot Trial of Financial Navigation and Peer Support to Improve Diabetes Outcomes
This study is testing whether combining financial help with peer support can improve health and reduce stress for people with diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06619834 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility and acceptability of a combined intervention that includes technology-supported financial navigation and peer support for individuals with diabetes. The study will assess the effectiveness of this approach in improving clinical outcomes such as A1c levels and blood pressure, as well as addressing financial stress and diabetes self-management behaviors. Participants will be compared between those receiving both interventions and those receiving financial navigation alone. The study seeks to understand how these interventions can help mitigate the economic burden of diabetes and enhance access to care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with diabetes who experience financial burdens and have elevated A1c levels.
Not a fit: Patients with serious psychiatric disorders or active substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve diabetes management and reduce financial stress for patients.
How similar studies have performed: While the specific combination of financial navigation and peer support is novel, similar studies have shown promise in addressing social determinants of health in diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants: * 18-75 years of age * diagnosis of diabetes with prescribed anti-hyperglycemic medication * most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of ≥7.5% for individuals ≤70 years and \>8.0% for individuals between 70-75 years in age * positive report of financial burden or cost-related non-adherence (CRN) using screening questions developed and validated from prior work 20-22 * be willing to provide personal health information in order to effectively participate in the intervention Peer Supporters: * International Classification of Diseases (ICD)-10 code for diabetes * In the past had A1cs\' \> 8.0% but whose most recent A1c in the prior 12 months is \<8.0%. * Past experience with economic burden or unmet social risk factors * Adults 18-75 years Exclusion Criteria: Participants: * a diagnosis of a serious psychiatric disorder (e.g., schizophrenia) * active alcohol or illicit drug use * current pregnancy or planning pregnancy * taking a medication that alters glucose metabolism (e.g., oral steroids) * report a comorbidity expected to limit life span to \< 3 years * Participation in another diabetes study, but the investigators will ask them if they would like to be peer supporters Peer Supporters: * A diagnosis of a serious psychiatric disorder (e.g., schizophrenia) * Active alcohol or illicit drug use * Current pregnancy or planning pregnancy
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Minal R. Patel, Ph.D, M.P.H
- Email: minalrp@umich.edu
- Phone: (734) 763-0087
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.