QBSafe for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen byKasia Lipska, MD MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for English or Spanish-speaking adults with Type 2 Diabetes who have an HbA1c level over 8%. It's open to patients able to give informed consent and healthcare providers involved in diabetes care. People with a life expectancy that makes higher HbA1c levels acceptable aren't eligible.

Inclusion Criteria

Participants able to sign informed consent

I am a healthcare professional involved in managing type 2 diabetes.

I have been diagnosed with type 2 diabetes.

See 2 more

Exclusion Criteria

My doctor and I agree that an HbA1c target above 8% is suitable for me.

Treatment Details

Interventions

QBSafe (Behavioral Intervention)

Trial OverviewThe QBSafe intervention, which includes conversation cards for patients to discuss their diabetes-related concerns and materials aiding clinicians' responses, is being tested for its impact on patient-reported outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: QBSafe interventionExperimental Treatment1 Intervention

Group II: usual careActive Control1 Intervention