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

December 13, 2022 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • Waterbury, Connecticut, United States, 06706
        • Trinity Health Of New England
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation Arm
Other: QBSAfe Toolkit
The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability - Patients
Time Frame: Baseline [Post Clinical Encounter]
Patient responses to post-visit questionnaires.
Baseline [Post Clinical Encounter]
Acceptability - Clinicians
Time Frame: Baseline [Post Clinical Encounter]
Clinician responses to post-visit questionnaires.
Baseline [Post Clinical Encounter]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility 1
Time Frame: Baseline [Post Clinical Encounter]
Percentage of participants who completed the study procedures.
Baseline [Post Clinical Encounter]
Feasibility 2
Time Frame: 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.
Baseline [Post Clinical Encounter]
Feasibility 3
Time Frame: Baseline [Post Clinical Encounter]
Time to recruit 84 subjects across 3 sites.
Baseline [Post Clinical Encounter]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)
Trinity Health Of New England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Actual)

September 22, 2020

Study Completion (Actual)

September 22, 2020

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000026483
  • 1R21AG061427-01 (U.S. NIH Grant/Contract)
  • 19-004560 (Other Identifier: Mayo)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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