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NCT05628181 · ClinicalTrials.gov registry record · NA
A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD)
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
NCT05628181: Completed NA study, sponsored by University of Michigan.
NCT05628181 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 129 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05628181, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
Study Summary
The goal of this project is to address central nervous system-active polypharmacy (CNS polyRx) in people living with dementia (PLWD) through focus groups and an educational intervention. The project included three interconnected aims and engaged PLWD, care partners (CP), and clinicians. Aim 1 consisted of focus group discussions with PLWD and CPs, conducted to inform the development of the educational intervention. This aim was not considered a clinical trial. Therefore, this registration covers Aims 2 and 3, which constitute the clinical trial components. These included mailing the educational "nudge" intervention to PLWD and conducting qualitative interviews with clinicians. No care partners were involved in Aims 2 and 3. The study hypothesizes that the total standardized daily dosage (TSDD) of medication classes contributing to CNS polyRx will decrease from baseline to 4 months among participants receiving the intervention.
Primary Outcome
CNS-polyRx included multiple meds from different classes. To track prescribing changes total standardized daily dosage (TSDD) unit is used. TSDD was calculated by dividing each med's prescribed daily dose by its Minimal Effective Geriatric Daily Dose (MEGDD) a framework for identifying the lowest effective daily dose for older adults to balance benefit and reduce harm. E.g., citalopram 20mg daily with MEGDD of 10mg=2 TSDD units. TSDD was assessed during 2 periods: 45day baseline and 45days befor
Interventions
- BEHAVIORAL Educational nudge intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2023-05-08 |
| Est. Completion | 2024-08-19 |
| Phase | NA |
What the finished NCT05628181 record still lists
NCT05628181 is an interventional study that assigns participants to a tested intervention. The registered 129 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 (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Educational nudge intervention is the first listed.
NCT05628181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05628181 about?
NCT05628181 is a clinical study titled "A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD)". The goal of this project is to address central nervous system-active polypharmacy (CNS polyRx) in people living with dementia (PLWD) through focus groups and an educational intervention. The project included three interconnected aims and engaged PLWD, care partners (CP), and clinicians. Aim 1 consi...
What is the current status of trial NCT05628181?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2023-05-08. Estimated completion is 2024-08-19.
What interventions are being tested in trial NCT05628181?
The interventions under investigation include: Educational nudge intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05628181?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05628181's enrollment target sits among peer trials
129 744th of 2000 higher than 1,257 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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