An interventional study of QBSAfe Toolkit in Diabetes and Diabetes Mellitus, sponsored by Yale University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-06.
Sponsored by Yale University · Not applicable, Interventional, and Health services research
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 91 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
-Existing diagnosis of diabetes mellitus; have an existing appointment with a participating clinician
Exclusion Criteria:
Other: QBSAfe Toolkit
The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
Acceptability - Patients
Patient responses to post-visit questionnaires.
Time frame: Baseline [Post Clinical Encounter]
Acceptability - Clinicians
Clinician responses to post-visit questionnaires.
Time frame: Baseline [Post Clinical Encounter]
Feasibility 1
Percentage of participants who completed the study procedures.
Time frame: Baseline [Post Clinical Encounter]
Feasibility 2
Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits.
Time frame: Baseline [Post Clinical Encounter]
Feasibility 3
Time to recruit 84 subjects across 3 sites.
Time frame: Baseline [Post Clinical Encounter]
84 participants and 7 clinicians
| Milestone | Single-Arm Intervention Group - Patients | Single-Arm Intervention Group - Clinicians |
|---|---|---|
| Started | 84 | 7 |
| Completed video or audio | 68 | 7 |
| Completed post visit questionnaire | 58 | 7 |
| Completed | 58 | 7 |
| Not completed | 26 | 0 |
Patient responses to post-visit questionnaires.
| Participants | Single-Arm Intervention Group |
|---|---|
| These cards helped me talk about my situation during my visit — Strongly Agree | 16 |
| These cards helped me talk about my situation during my visit — Agree | 21 |
| These cards helped me talk about my situation during my visit — Neutral | 12 |
| These cards helped me talk about my situation during my visit — Disagree | 6 |
| These cards helped me talk about my situation during my visit — Strongly Disagree | 3 |
| I would like to have these cards available to me at my next visit — Strongly Agree | 12 |
| I would like to have these cards available to me at my next visit — Agree | 10 |
| I would like to have these cards available to me at my next visit — Neutral | 21 |
| I would like to have these cards available to me at my next visit — Disagree | 12 |
| I would like to have these cards available to me at my next visit — Strongly Disagree | 3 |
| I believe other patients like me would benefit from these cards — Strongly Agree | 19 |
| I believe other patients like me would benefit from these cards — Agree | 26 |
| I believe other patients like me would benefit from these cards — Neutral | 9 |
| I believe other patients like me would benefit from these cards — Disagree | 3 |
| I believe other patients like me would benefit from these cards — Strongly Disagree | 1 |
Clinician responses to post-visit questionnaires.
| Questionnaires after each encounter | Single-Arm Intervention Group |
|---|---|
| I felt confident in responding to issues raised by the patient — Strongly Agree | 48 |
| I felt confident in responding to issues raised by the patient — Agree | 14 |
| I felt confident in responding to issues raised by the patient — Neutral | 4 |
| I felt confident in responding to issues raised by the patient — Disagree | 3 |
| I felt confident in responding to issues raised by the patient — Strongly Disagree | 0 |
| I would like to use these cards with a patient like this next time — Strongly Agree | 43 |
| I would like to use these cards with a patient like this next time — Agree | 11 |
| I would like to use these cards with a patient like this next time — Neutral | 14 |
| I would like to use these cards with a patient like this next time — Disagree | 1 |
| I would like to use these cards with a patient like this next time — Strongly Disagree | 0 |
| I would recommend these cards to my colleagues — Strongly Agree | 46 |
| I would recommend these cards to my colleagues — Agree | 10 |
| I would recommend these cards to my colleagues — Neutral | 11 |
| I would recommend these cards to my colleagues — Disagree | 1 |
| I would recommend these cards to my colleagues — Strongly Disagree | 0 |
Percentage of participants who completed the study procedures.
| Participants | Single-Arm Intervention Group - Patients | Single-Arm Intervention Group - Clinicians |
|---|---|---|
| Feasibility 1 | 58 | 7 |
Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits.
| percentage of visits QBSAFE was used | Implementation Arm |
|---|---|
| Feasibility 2 | 58 |
Time to recruit 84 subjects across 3 sites.
| Days | Implementation Arm |
|---|---|
| Feasibility 3 | 145 |
Collected over Up to 1 week.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-Arm Intervention Group | 0/84 (0%) | 0/84 (0%) | 0/84 (0%) |
| Clinicians | — | — | — |
Baseline characteristics were not collected for clinicians
| Age, Categorical(Participants) | Implementation Arm | Clinicians | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 39 | — | 39 |
| >=65 years | 45 | — | 45 |
| Age, Continuous(years) | Implementation Arm | Clinicians | Total |
|---|---|---|---|
| Mean | 74.4 ± 15.4 | — | 74.4 ± 15.4 |
| Sex: Female, Male(Participants) | Implementation Arm | Clinicians | Total |
|---|---|---|---|
| Female | 39 | — | 39 |
| Male | 45 | — | 45 |
| Race (NIH/OMB)(Participants) | Implementation Arm | Clinicians | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 14 | — | 14 |
| White | 66 | — | 66 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 4 | — | 4 |
| Region of Enrollment(participants) | Implementation Arm | Clinicians | Total |
|---|---|---|---|
| United States | 84 | — | 84 |
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Yale University