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Behavioral Intervention
Educational Nudge Intervention for Overmedication in People Living With Dementia
N/A
Waitlist Available
Led By Donovan Maust, MD, MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 months (after sending the educational tool)
Awards & highlights
Study Summary
This trial will help reduce medications for people with dementia to improve their care.
Who is the study for?
This trial is for people with dementia or mild cognitive impairment who are being treated at selected Michigan Medicine and Henry Ford Health System clinics. Participants must be taking three or more medications that affect the central nervous system, like antidepressants or opioids.Check my eligibility
What is being tested?
The study tests an educational 'nudge' designed to reduce the use of multiple mind-affecting drugs in those living with dementia. It aims to lower the total daily dosage of these medications over a four-month period.See study design
What are the potential side effects?
Since this intervention is educational, it does not involve direct medical treatments or drugs; therefore, traditional physical side effects are not expected. However, changes in medication regimens could lead to withdrawal symptoms or changes in behavior.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 months (after sending the educational tool)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 months (after sending the educational tool)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the total standardized daily dosage (TSDD) of the medication classes contributing to CNS polyRx as measured in the EHR
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Educational nudge interventionExperimental Treatment1 Intervention
Participants will be mailed the educational tool in the form of a brochure.
Group II: No educational toolActive Control1 Intervention
This arm will collect data on total standardized daily dosage of the medication classes contributing to CNS polyRx from the Electronic Medical Record (EMR).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Educational nudge intervention
2023
N/A
~150
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,807 Previous Clinical Trials
6,383,230 Total Patients Enrolled
9 Trials studying Dementia
1,570 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,684 Previous Clinical Trials
28,025,695 Total Patients Enrolled
272 Trials studying Dementia
23,628,107 Patients Enrolled for Dementia
Donovan Maust, MD, MSPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking three or more certain types of medications that affect the central nervous system such as antidepressants, antipsychotics, or opioids.You are getting medical care at specific primary care clinics at Michigan Medicine and Henry Ford Health System.You have been diagnosed with dementia or mild cognitive impairment.
Research Study Groups:
This trial has the following groups:- Group 1: No educational tool
- Group 2: Educational nudge intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies in this clinical experiment?
"The records available on clinicaltrials.gov indicate that this trial, which was published in February 28th of 2023 and updated last December 6th 2022, is not currently seeking participants; however, there are 424 alternative studies actively recruiting patients now."
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