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

NCT05553912 | Completed DMC

• 2 other identifiers: 20000326541R01DK129616-01A1
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2Diabetes; Diabetes

Keywords

A1c; HbA1c

Outcome Measures

Primary Outcomes (2)

• Illness intrusiveness measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6

  The change in illness intrusiveness measured by the validated Illness Intrusiveness Ratings Scale (IIRS). IIRS is comprised of 13 items that ask participants to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. the score is calculated by summing the 13 items creating a value between 13 to 91, where higher scores indicate increased illness intrusiveness. Analysis will assess the 6 months response as the outcome adjusting for arm and the initial score

  Month 6

• HbA1c at Month 6

  HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score.

  Month 6

Secondary Outcomes (5)

• Diabetes distress will be measured using the Diabetes Distress Scale (DDS-17) at Month 6

  Month 6

• Treatment burden will be assessed using the Treatment Burden Questionnaire (TBQ) at Month 6

  Month 6

• Quality of life was assessed using the Visual Analogue Scale (VAS) at Month 6.

  Month 6

• Hypoglycemia measured at month 6

  Month 6

• Quality of communication assessed using 3 questions from the CAHPS Clinician and Group survey

  up to 6 months

Other Outcomes (2)

• Patient satisfaction survey

  up to 6 months

• Clinician satisfaction survey

  up to 6 months

Study Arms (2)

QBSafe intervention

EXPERIMENTAL

Behavioral: QBSafe

usual care

NO INTERVENTION

Interventions

QBSafe 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.

QBSafe intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Fair Haven Community Health Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kasia Lipska, MD MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cluster randomized clinical trial of usual care with a behavioral intervention (use of conversation cards during routine clinical encounters) compared with usual care alone. The study will randomize 10-15 clinicians and 72 of their patients with type 2 diabetes to each arm. Data collected includes medical record data, patient and clinician surveys, and audio-visual recordings of clinical encounters.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: November 2, 2022
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)