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

NCT04514523 | Completed Results

• 3 other identifiers: 20000264831R21AG061427-0119-004560
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Acceptability - Patients

  Patient responses to post-visit questionnaires.

  Baseline [Post Clinical Encounter]

• Acceptability - Clinicians

  Clinician responses to post-visit questionnaires.

  Baseline [Post Clinical Encounter]

Secondary Outcomes (3)

• Feasibility 1

  Baseline [Post Clinical Encounter]

• Feasibility 2

  Baseline [Post Clinical Encounter]

• Feasibility 3

  Baseline [Post Clinical Encounter]

Study Arms (1)

Implementation Arm

EXPERIMENTAL

Other: QBSAfe Toolkit

Interventions

QBSAfe Toolkit OTHER

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

Implementation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• Trinity Health Of New England: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Yale University

New Haven, Connecticut, 06520, United States

Location

Trinity Health of New England

Waterbury, Connecticut, 06706, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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.

  PMID: 34749816 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Kasia Lipska
• Organization: Yale School of Medicine

kasia.lipska@yale.edu

203-737-4853

Study Officials

• Victor Montori, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Study Start: April 28, 2020
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: January 6, 2023
• Results First Posted: January 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)