Improving care for people with Type 2 Diabetes using a novel intervention
QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
NA · Yale University · NCT05553912
This study is testing a new way to help people with Type 2 Diabetes share their concerns and improve their overall health by using conversation cards and support materials for their doctors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05553912 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the QBSafe intervention, which includes conversation cards for patients to express their diabetes-related concerns and materials for clinicians to address these concerns. The study will compare the usual care approach with the QBSafe intervention in a cluster randomized design among patients with Type 2 Diabetes. The focus is on assessing both the feasibility of the intervention and its impact on patient-reported outcomes, emphasizing overall health and wellbeing rather than solely glycemic control.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Type 2 Diabetes who have an HbA1c level greater than 8% and can communicate in English or Spanish.
Not a fit: Patients with an HbA1c target greater than 8% that is clinically reasonable or aligned with their goals may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the quality of diabetes care by addressing patients' holistic health needs.
How similar studies have performed: Other studies have shown promise in using patient-centered approaches to improve diabetes care, indicating that this intervention may build on established concepts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Clinicians * any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (DM2) management (DM2) and prescribe medications for them Participants * diagnosed with DM2 * able to sign informed consent * fluent in either English or Spanish * HbA1c \>8% Exclusion Criteria: * Participants for whom an HbA1c target \>8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences
Where this trial is running
New Haven, Connecticut
- Fair Haven Community Health Center — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Kasia Lipska, MD MHS — Yale University
- Study coordinator: Kasia Lipska, MD MHS
- Email: kasia.lipska@yale.edu
- Phone: 203-500-3053
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.
Conditions: Type2Diabetes, Diabetes, A1c, HbA1c