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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG061427-01 | U.S. NIH Grant/Contract | View source | |
| 19-004560 | Other Identifier | Mayo |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Trinity Health Of New England | OTHER |
| National Institute on Aging (NIA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QBSAfe Toolkit | Other | The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability - Patients | Patient responses to post-visit questionnaires. | Baseline [Post Clinical Encounter] |
| Acceptability - Clinicians | Clinician responses to post-visit questionnaires. | Baseline [Post Clinical Encounter] |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility 1 | Percentage of participants who completed the study procedures. | 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. |
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Inclusion Criteria:
-Existing diagnosis of diabetes mellitus; have an existing appointment with a participating clinician
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Montori, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| Trinity Health of New England |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34749816 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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84 participants and 7 clinicians
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-Arm Intervention Group - Patients | QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety. |
| FG001 | Single-Arm Intervention Group - Clinicians |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 8, 2020 | Nov 17, 2022 |
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| Baseline [Post Clinical Encounter] |
| Feasibility 3 | Time to recruit 84 subjects across 3 sites. | Baseline [Post Clinical Encounter] |
| Waterbury |
| Connecticut |
| 06706 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
Clinicians who participated in the study |
| Completed Video or Audio |
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| Completed Post Visit Questionnaire |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were not collected for clinicians
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| ID | Title | Description |
|---|---|---|
| BG000 | Implementation Arm | QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety. |
| BG001 | Clinicians | Clinicians who participated in the study |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Baseline characteristics were not collected for clinicians | Count of Participants | Participants |
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| Age, Continuous | Baseline characteristics were not collected for clinicians | Mean | Standard Deviation | years |
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| Sex: Female, Male | Baseline characteristics were not collected for clinicians | Count of Participants | Participants |
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| Race (NIH/OMB) | Baseline characteristics were not collected for clinicians | Count of Participants | Participants |
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| Region of Enrollment | Baseline characteristics were not collected for clinicians | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability - Patients | Patient responses to post-visit questionnaires. | Patients who had their visit recorded and answered post visit questionnaires | Posted | Count of Participants | Participants | Baseline [Post Clinical Encounter] |
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| Primary | Acceptability - Clinicians | Clinician responses to post-visit questionnaires. | Questionnaires completed by clinicians after each patient encounter | Posted | Count of Units | Questionnaires after each encounter | Baseline [Post Clinical Encounter] | Questionnaires after each encounter | Questionnaires after each encounter |
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| Secondary | Feasibility 1 | Percentage of participants who completed the study procedures. | Number of patients and number of clinicians in the study | Posted | Count of Participants | Participants | Baseline [Post Clinical Encounter] |
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| Secondary | 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. | Posted | Number | percentage of visits QBSAFE was used | Baseline [Post Clinical Encounter] |
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| Secondary | Feasibility 3 | Time to recruit 84 subjects across 3 sites. | Number of recruited patients | Posted | Number | Days | Baseline [Post Clinical Encounter] |
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Up to 1 week.
Study took place during routine clinical encounters. A subgroup of participants were followed for up to a week to complete qualitative interviews. Adverse events were not tracked for clinician arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-Arm Intervention Group | QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety. | 0 | 84 | 0 | 84 | 0 | 84 |
| EG001 | Clinicians | Clinicians who participated in study | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kasia Lipska | Yale School of Medicine | 203-737-4853 | kasia.lipska@yale.edu |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Disagree |
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| Strongly Disagree |
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| I would like to have these cards available to me at my next visit |
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| I believe other patients like me would benefit from these cards |
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| Questionnaires after each encounter |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories |
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| Neutral |
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| Disagree |
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| Strongly Disagree |
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| Neutral |
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| Disagree |
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| Strongly Disagree |
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