COMPLETED

QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Glycemic control is often the main indicator of successful diabetes care, but a singular focus on glycemic control may lead to patients' overall health and wellbeing being overlooked or undervalued. The investigators have previously developed an intervention comprised of (a) a set of conversation cards designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. The investigators will now conduct a randomized clinical trial to test the feasibility of the research procedures and efficacy of the intervention with respect to patient reported outcome measures.

Official Title

QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.

Quick Facts

Study Start:2022-11-02
Study Completion:2025-02-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05553912

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (DM2) management (DM2) and prescribe medications for them
  2. * diagnosed with DM2
  3. * able to sign informed consent
  4. * fluent in either English or Spanish
  5. * HbA1c \>8%
  1. * Participants for whom an HbA1c target \>8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences

Contacts and Locations

Principal Investigator

Kasia Lipska, MD MHS
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Fair Haven Community Health Center
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Kasia Lipska, MD MHS, PRINCIPAL_INVESTIGATOR, Yale University

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 Registration Dates

Study Start Date2022-11-02
Study Completion Date2025-02-24

Study Record Updates

Study Start Date2022-11-02
Study Completion Date2025-02-24

Terms related to this study

Keywords Provided by Researchers

  • A1c
  • HbA1c

Additional Relevant MeSH Terms

  • Type2Diabetes
  • Diabetes