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

NCT ID: NCT05553912

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2025-02-24

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.

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.

Conditions

Type2Diabetes; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

QBSafe intervention

Group Type: EXPERIMENTAL

QBSafe

Intervention Type: BEHAVIORAL

an intervention comprised of (a) a set of conversation cards (QBSafe ASK) 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.

usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

QBSafe

an intervention comprised of (a) a set of conversation cards (QBSafe ASK) 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kasia Lipska, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Fair Haven Community Health Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R01DK129616-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000032654

Identifier Type: -

Identifier Source: org_study_id