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NCT05553912 · ClinicalTrials.gov registry record · NA
QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 143
- Enrollment target
NCT05553912: Completed NA study, sponsored by Yale University.
NCT05553912 is a NA study that has completed, run by Yale University. The registered enrollment target is 143 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05553912, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 143 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The change in illness intrusiveness measured by the validated Illness Intrusiveness Ratings Scale (IIRS). IIRS is comprised of 13 items that ask participants to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. Overall score is calculated by summing the 13 items creating a value between 13 to 91, where higher scores indicate increased illness intrusiveness. Analysis will assess the 6 months response as the outcome adjusting for
Interventions
- BEHAVIORAL QBSafe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2025-02-24 |
| Phase | NA |
What the finished NCT05553912 record still lists
NCT05553912 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which QBSafe is the first listed.
NCT05553912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05553912 about?
NCT05553912 is a clinical study titled "QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.". 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 ca...
What is the current status of trial NCT05553912?
This trial is currently completed. It is a NA study. The enrollment target is 143 participants. The study started on 2022-11-02. Estimated completion is 2025-02-24.
What interventions are being tested in trial NCT05553912?
The interventions under investigation include: QBSafe (BEHAVIORAL).
Who is sponsoring clinical trial NCT05553912?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05553912's enrollment target sits among peer trials
143 711th of 2000 higher than 1,290 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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