- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07799610
Senior Center Medication Safety and Empowerment Curriculum
August 27, 2026 updated by: Robert Wahler, State University of New York at Buffalo
Team Alice Senior Center Medication Safety and Empowerment Curriculum
Team Alice's Medication Safety and Empowerment Curriculum (MedSEC) helps older adults and caregivers learn how to safely manage medications.
Many seniors take multiple medications, which can lead to harmful side effects or unnecessary treatments.
This program, developed at the University at Buffalo, will be offered at senior centers in Western New York.
It includes two interactive sessions that teach participants how to recognize medication risks and talk with their doctors about safer options.
The curriculum uses videos, group discussions, and hands-on tools to build confidence and knowledge.
It follows the "4Ms" of Age-Friendly Health Systems: What Matters, Medication, Mentation, and Mobility.
A "Train-the-Trainer" model will help senior center staff continue the program long-term.
The goal is to reduce medication harm, improve communication with healthcare providers, and support healthy aging in the community.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 142148033
- Recruiting
- University at Buffalo
-
Contact:
- Robert G Wahler, Doctor of Pharmacy
- Phone Number: 7166454777
- Email: rgwahler@buffalo.edu
-
Principal Investigator:
- Robert G Wahler, Doctor of Pharmacy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 55 years of age and above
- taking prescription medications
Carepartner Inclusion Criteria:
- currently an informal or formal care partner for an eligible patient (regardless of whether they live with or near the patient)
- aged 18 years of age and above
Exclusion Criteria:
- Patients with cognitive impairment that prevents their self-management of medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the impact of the MedSEC on patient/care-partner knowledge and activation levels in managing medications through the Patient Activation Measure (PAM)
Time Frame: Change from baseline (Day 1), post-program assessment (immediately after educational session 2, Day 7), and 6 months after program completion.
|
Study seeks to enhance patient and care-partner activation, reduce polypharmacy and the use of potentially inappropriate medications (PIMs), and improve shared decision-making through the Patient Activation Measure (PAM).
|
Change from baseline (Day 1), post-program assessment (immediately after educational session 2, Day 7), and 6 months after program completion.
|
|
Evaluate the impact of the MedSEC on patient/care-partner knowledge and activation levels in managing medications through the Revised Patient Attitudes Towards Deprescribing (rPATD) questionnaires.
Time Frame: Change from baseline (Day 1), post-program assessment (immediately after educational session 2, Day 7), and 6 months after program completion.
|
Study seeks to enhance patient and care-partner activation, reduce polypharmacy and the use of potentially inappropriate medications (PIMs), and improve shared decision-making through the Revised Patient Attitudes Towards Deprescirbing (rPATD) questionnaires.
|
Change from baseline (Day 1), post-program assessment (immediately after educational session 2, Day 7), and 6 months after program completion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in participant understanding of medication safety risks at 6 Months.
Time Frame: Change from baseline (Day 1), post-program assessment (immediately after educational session 2, Day 7), and 6 months after program completion.
|
85% of participants will demonstrate an understanding of medication safety risks through pre- and post-program patient/caregiver questionnaires, including the Patient Activation Measure (PAM) and Revised Patient Attitudes to Deprescribing (rPATD).
Additional questions pertaining to knowledge retention and actionability will be asked at 6 months.
|
Change from baseline (Day 1), post-program assessment (immediately after educational session 2, Day 7), and 6 months after program completion.
|
|
Participants will demonstrate knowledge of the 4Ms (Age-Friendly Health System) framework through pre/post/6 month follow up questionnaires.
Time Frame: Change from baseline, post-program assessment (immediately after program completion), and 6 months after program completion.
|
By the end of the program, 80% of participants will demonstate knowledge of the 4Ms framework, measured by four questions related to the 4Ms and the Age-Friendly Health System taken prior to the program, immediately post-program, and 6 months after program completion.
|
Change from baseline, post-program assessment (immediately after program completion), and 6 months after program completion.
|
|
Change in patient engagement as measured by the Patient Activation Measure (PAM) from baseline to 6 months post program.
Time Frame: Change from baseline (Day 1), post-program assessment (immediately after educational session 2, Day 7), and 6 months after program completion.
|
6 months post-program, 65% of participants will show improved patient engagement, as measured by the Patient Activation Measure (PAM) questionnaire.
|
Change from baseline (Day 1), post-program assessment (immediately after educational session 2, Day 7), and 6 months after program completion.
|
|
Change from baseline in the mean of medications after 6 months follow-up
Time Frame: Change from baseline and 6 months after program completion.
|
Within 6 months of completing program, 50% of participants with polypharmacy will have reduced medication usage by 10%.
(mean # of medications.)
|
Change from baseline and 6 months after program completion.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Survey to Measure Program Impact and Participant Satisfaction
Time Frame: Post curriculum session 2 (immediately after educational session 2, Day 7)
|
A post-survey questionnaire (immediately after program completion) will be used to assess the program's educational value and determine its effectiveness in increasing medication safety knowledge, empowerment, and patient self-advocacy, as well as participant satisfaction.
|
Post curriculum session 2 (immediately after educational session 2, Day 7)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
November 21, 2025
First Submitted That Met QC Criteria
August 27, 2026
First Posted (Actual)
September 2, 2026
Study Record Updates
Last Update Posted (Actual)
September 2, 2026
Last Update Submitted That Met QC Criteria
August 27, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00009882
- G-202509-02155 (Other Grant/Funding Number: Health Foundation for Western & Central New York)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.