QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events
Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT04514523
Collaborator
National Institutes of Health (NIH) (NIH), Trinity Health of New England (Other), National Institute on Aging (NIA) (NIH)
84
3
1
4.8
28
5.8
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Apr 28, 2020
Actual Primary Completion Date
:
Sep 22, 2020
Actual Study Completion Date
:
Sep 22, 2020
Arms and Interventions
| 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
Primary Outcome Measures
- Change in Patient/Clinician Conversation Topics [Baseline [During Clinical Encounter]]
We will identify differences in topics discussed by patients and clinicians during clinical encounters.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University | New Haven | Connecticut | United States | 06520 |
| 2 | Trinity Health of New England | Waterbury | Connecticut | United States | 06706 |
| 3 | 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
- Principal Investigator: Victor Montori, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04514523
Other Study ID Numbers:
- 2000026483
- 1R21AG061427-01
- 19-004560
First Posted:
Aug 17, 2020
Last Update Posted:
Mar 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: