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NCT06368115 · ClinicalTrials.gov registry record · NA
A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2
A NA study of Alzheimer Disease, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- NA
- Development phase
- 11,375
- Enrollment target
- 1
- Study location
NCT06368115: Completed NA study of Alzheimer Disease, sponsored by University of Massachusetts, Worcester.
NCT06368115 is a NA study of Alzheimer Disease that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 11,375 participants, above the 2,714-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (319% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06368115, a NA study of Alzheimer Disease, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- NA
- Development phase
- 11,375 participants
- Enrollment target
- 1
- Study location
Study Summary
Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of pati
Primary Outcome
The primary outcome will be defined as absence of any dispensing of the targeted inappropriate prescription class from day 91 to day 270 during the 9 months following receipt of intervention. These 9 months are split into a 3-month black-out period followed by a six-month observation period, or days 91-270.
Conditions Studied
Interventions
- OTHER Educational Materials
Study Locations (1)
Massachusetts
- UMass Chan Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,375 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2026-01-01 |
| Phase | NA |
What the finished NCT06368115 record still lists
NCT06368115 is an interventional study that assigns participants to a tested intervention. Its 11,375 participants enrollment target places it among the larger protocols in the corpus, above the 2,714-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (319% higher).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which Educational Materials is the first listed.
NCT06368115 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06368115 about?
NCT06368115 is a clinical study titled "A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2". Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescri...
What is the current status of trial NCT06368115?
This trial is currently completed. It is a NA study. The enrollment target is 11,375 participants. The study started on 2024-07-01. Estimated completion is 2026-01-01.
What conditions does trial NCT06368115 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT06368115?
The interventions under investigation include: Educational Materials (OTHER).
Who is sponsoring clinical trial NCT06368115?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06368115 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06368115's enrollment target sits among peer trials
11,375 9th of 306 higher than 298 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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.
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