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NCT05628181

A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD)

Completed NA Results posted Last updated 24 July 2025
What this trial tests

NA trial testing Educational nudge intervention in Polypharmacy in 129 participants. Completed in 19 August 2024.

Timeline
8 May 2023
Primary endpoint
19 January 2024
19 August 2024

Quick facts

Lead sponsorUniversity of Michigan
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment129
Start date8 May 2023
Primary completion19 January 2024
Estimated completion19 August 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Michigan

Who can join

50 and older, any sex, with Polypharmacy or Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Total Standardized Daily Dosage (TSDD) of CNS-Active Medications From Baseline to 4 Months, as Measured in the EHR Primary · Baseline (i.e., the 45 days prior to intervention) and 4 months post-intervention (i.e., the final 45 days of the 4-month period)

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 before the 4month follow-up. For each period, the total supply of each CNS-active med was summed and divi

TSDD At Baseline
GroupValue95% CI
No Educational Tool9.0± 7.2
Educational Nudge Intervention9.0± 7.2
TSDD at 4 months
GroupValue95% CI
No Educational Tool-1.3± 5.8
Educational Nudge Intervention-1.6± 6.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

No Educational Tool
Serious: 2/68 (3%)
Deaths: 2/68
Educational Nudge Intervention
Serious: 4/61 (7%)
Deaths: 4/61
Clinicians
Serious: 0
Deaths: 0

Serious adverse events (1 terms)

ReactionSystemNo Educational ToolEducational Nudge Interven…Clinicians
DeathGeneral disorders

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT05628181 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. An Educational Intervention to Promote Central Nervous System-Active Deprescribing in Dementia: A Pilot Study.
    Barnett NM, Vordenberg SE, Kim HM, Turnwald M, et al · · 2025 · cited 1× · PMID 39832105 · DOI 10.1007/s40266-024-01178-x

Verify or expand the search:

Other recruiting trials for Polypharmacy

Currently open trials in the same condition.

Other University of Michigan trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05628181.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing