QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events

Not Applicable

Completed

• Conditions: Diabetes; Diabetes Mellitus
• Interventions: Other: QBSAfe Toolkit

• Registration Number: NCT04514523
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to co-develop a toolkit (known as the QBSAfe toolkit) with patients, family caregivers, and clinicians that focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety for patients with diabetes mellitus.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-04-28
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-17
• Primary Completion: 2020-09-22
• Study Completion: 2020-09-22
• Results First Submitted: 2022-10-21
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Results First Posted: 2023-01-06
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

-Existing diagnosis of diabetes mellitus; have an existing appointment with a participating clinician

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Exclusion Criteria

• Do not speak English
• Severe vision/hearing impairment
• Unable to give informed consent for any reason

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implementation Arm	QBSAfe Toolkit	-

Primary Outcome Measures

Name	Time	Method
Acceptability - Clinicians	Baseline [Post Clinical Encounter]	Clinician responses to post-visit questionnaires.
Acceptability - Patients	Baseline [Post Clinical Encounter]	Patient responses to post-visit questionnaires.

Secondary Outcome Measures

Name	Time	Method
Feasibility 2	Baseline [Post Clinical Encounter]	Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits.
Feasibility 3	Baseline [Post Clinical Encounter]	Time to recruit 84 subjects across 3 sites.
Feasibility 1	Baseline [Post Clinical Encounter]	Percentage of participants who completed the study procedures.

Trial Locations

Locations (3)

Trinity Health of New England; 🇺🇸 Waterbury, Connecticut, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States