DiabetesQBSAfeNCT04514523

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

A study testing QBSAfe Toolkit in people with Diabetes and Diabetes Mellitus, run by Yale University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus
What is being tested?: QBSAfe Toolkit
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 3 sitesUnited States
Study dates: 28 Apr 2020to 22 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Yale University
New Haven, Connecticut, 06520
Mayo Clinic
Rochester, Minnesota, 55905
Trinity Health of New England
Waterbury, Connecticut, 06706

Other trials in United States

About this study

Conditions: Diabetes, Diabetes Mellitus
Being tested: QBSAfe Toolkit
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04514523
Study group	Role	What they receive
Implementation Arm	Experimental	Not described Receives: Other: QBSAfe Toolkit

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability - Patients
Patient responses to post-visit questionnaires.
Measured: Baseline [Post Clinical Encounter]
Acceptability - Clinicians
Clinician responses to post-visit questionnaires.
Measured: Baseline [Post Clinical Encounter]

Secondary outcomes (3)

Feasibility 1
Percentage of participants who completed the study procedures.
Measured: 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.
Measured: Baseline [Post Clinical Encounter]
Feasibility 3
Time to recruit 84 subjects across 3 sites.
Measured: Baseline [Post Clinical Encounter]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 202022 Sep 2020

First posted17 Aug 2020
Study start28 Apr 2020
Primary completion22 Sep 2020
Study completion22 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04514523
Sponsor's protocol ID: 2000026483
Other IDs: 1R21AG061427-01, 19-004560
Acronym: QBSAfe
Status last verified: Dec 2022
First submitted: 12 Aug 2020
Last updated: 6 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34749816

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events
ClinicalTrials.gov ID: NCT04514523
Acronym / sponsor ID: QBSAfe / 2000026483
Conditions: Diabetes, Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), Trinity Health Of New England, National Institute on Aging (NIA)
Study start: 28 Apr 2020 (actual)
Primary completion: 22 Sep 2020 (actual)
Study completion: 22 Sep 2020 (actual)
First posted: 17 Aug 2020 (actual)
Results: Posted 6 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Implementation Arm	Experimental	Other: QBSAfe Toolkit

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QBSAfe ToolkitThe QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.	Other	Implementation Arm

Primary outcome

Acceptability - Patients
Time frame: Baseline [Post Clinical Encounter]
Patient responses to post-visit questionnaires.
Acceptability - Clinicians
Time frame: Baseline [Post Clinical Encounter]
Clinician responses to post-visit questionnaires.

3 secondary outcomes

Feasibility 1
Time frame: Baseline [Post Clinical Encounter]
Feasibility 2
Time frame: Baseline [Post Clinical Encounter]
Feasibility 3
Time frame: Baseline [Post Clinical Encounter]

Results and safety

Results posted to the registry on 6 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-Arm Intervention Group - Patients	84	58
Single-Arm Intervention Group - Clinicians	7	7

Primary outcome: Acceptability - Patients

Time frame: Baseline [Post Clinical Encounter]. Count of participants. Unit: Participants

Measure	Single-Arm Intervention Group n = 58
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

Population analysed: Patients who had their visit recorded and answered post visit questionnaires

Primary outcome: Acceptability - Clinicians

Time frame: Baseline [Post Clinical Encounter]. Count of units. Unit: Questionnaires after each encounter

Measure	Single-Arm Intervention Group n = 7
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

Population analysed: Questionnaires completed by clinicians after each patient encounter

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 week.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-Arm Intervention Group	0 of 84 (0%)	0 of 84 (0%)	0 of 84
Clinicians	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34749816Clark 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Victor Montori, MD principal investigator

Mayo Clinic

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing QBSAfe Toolkit in people with Diabetes and Diabetes Mellitus, run by Yale University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability - Patients (time frame: Baseline [Post Clinical Encounter]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04514523, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.