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

Diabetes Clinical Trial

— QBSAfe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514523
• Other study ID #: 2000026483
• Secondary ID: 1R21AG061427-011
• Status: Completed
• Phase: N/A
• Start date: April 28, 2020
• Est. completion date: September 22, 2020

Study information

• Verified date: December 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 22, 2020
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Do not speak English

• Severe vision/hearing impairment

• Unable to give informed consent for any reason

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• QBSAfe Toolkit
The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	Mayo Clinic	Rochester	Minnesota
United States	Trinity Health of New England	Waterbury	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	National Institute on Aging (NIA), National Institutes of Health (NIH), Trinity Health of New England

Country where clinical trial is conducted

United States, 

References & Publications (1)

Clark JE, Boehmer KR, Breslin M, Haider S, Pasciak W, Gravholt D, Sanchez BB, Hartasanchez SA, El Kawkgi OM, Montori V, Lipska KJ. Quality of life, burden of treatment, safety, and avoidance of future events (QBSAfe) protocol: a pilot study testing an intervention to shift the paradigm of diabetes care. Pilot Feasibility Stud. 2021 Nov 8;7(1):196. doi: 10.1186/s40814-021-00935-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability - Patients	Patient responses to post-visit questionnaires.	Baseline [Post Clinical Encounter]
Primary	Acceptability - Clinicians	Clinician responses to post-visit questionnaires.	Baseline [Post Clinical Encounter]
Secondary	Feasibility 1	Percentage of participants who completed the study procedures.	Baseline [Post Clinical Encounter]
Secondary	Feasibility 2	Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits.	Baseline [Post Clinical Encounter]
Secondary	Feasibility 3	Time to recruit 84 subjects across 3 sites.	Baseline [Post Clinical Encounter]

External Links

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