QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.

Completed · Not applicable

Conditions studied: Type2Diabetes, Diabetes

In brief

Glycemic control is often the main indicator of successful diabetes care, but a singular focus on glycemic control may lead to patients' overall health and wellbeing being overlooked or undervalued. The investigators have previously developed an intervention comprised of (a) a set of conversation cards designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. The investigators will now conduct a randomized clinical trial to test the feasibility of the research procedures and efficacy of the intervention with respect to patient reported outcome measures.

Key facts

Study ID

NCT05553912

Run by

Yale University

People needed

154

Starts

2022-11-02

Expected to finish

2025-02-24

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• Participants for whom an HbA1c target >8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences

Where it is running

• Fair Haven Community Health Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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