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NCT05553912 | Recruiting | Type2Diabetes


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

Yale University

Brief Summary:

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.

Condition or disease

Type 2 Diabetes

Diabetes

Intervention/treatment

QBSafe

Phase

Not Applicable

Detailed Description:

The goal of this study is to assess the feasibility and efficacy of usual care with the QBSafe intervention compared to usual care alone within a cluster randomized clinical trial among patients with type 2 diabetes.}}

Study Type : Interventional
Estimated Enrollment : 164 participants
Masking : None (Open Label)
Primary Purpose : Supportive Care
Official Title : QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
Actual Study Start Date : November 2, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : March 2025
Arm Intervention/treatment

Experimental: QBSafe intervention

No Intervention: usual care

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Connecticut

Fair Haven Community Health Center

New Haven, Connecticut, United States, 06510

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