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OpenTrials
Completed

NCT Number: NCT04514523

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QBSAfe Toolkit

Other

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

Primary outcomes

  1. Acceptability - Patients

    Time frame: Baseline [Post Clinical Encounter]

    Patient responses to post-visit questionnaires.

  2. Acceptability - Clinicians

    Time frame: Baseline [Post Clinical Encounter]

    Clinician responses to post-visit questionnaires.

Secondary outcomes

  1. Feasibility 1

    Time frame: Baseline [Post Clinical Encounter]

    Percentage of participants who completed the study procedures.

  2. 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.

  3. Feasibility 3

    Time frame: Baseline [Post Clinical Encounter]

    Time to recruit 84 subjects across 3 sites.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Acronym: QBSAfe

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2020
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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