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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04514523
Recruitment Status : Completed
First Posted : August 17, 2020
Last Update Posted : March 11, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Trinity Health of New England
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus Other: QBSAfe Toolkit Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events
Actual Study Start Date : April 28, 2020
Actual Primary Completion Date : September 22, 2020
Actual Study Completion Date : September 22, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Patient/Clinician Conversation Topics [ Time Frame: Baseline [During Clinical Encounter] ]
    We will identify differences in topics discussed by patients and clinicians during clinical encounters.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514523


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Trinity Health of New England
Waterbury, Connecticut, United States, 06706
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Trinity Health of New England
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Victor Montori, MD Mayo Clinic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04514523    
Other Study ID Numbers: 2000026483
1R21AG061427-01 ( U.S. NIH Grant/Contract )
19-004560 ( Other Identifier: Mayo )
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases