NCT07799610

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

November 21, 2025

Last Update Submit

August 27, 2026

Conditions

Keywords

older adultpatient educationcaregiver educationmedication safetypatient knowledgepatient empowerment

Outcome Measures

Primary Outcomes (2)

  • Evaluate the impact of the MedSEC on patient/care-partner knowledge and activation levels in managing medications through the Patient Activation Measure (PAM)

    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.

    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 Outcomes (4)

  • Change from Baseline in participant understanding of medication safety risks 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.

    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.

    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

    Change from baseline and 6 months after program completion.

Other Outcomes (1)

  • Post-Survey to Measure Program Impact and Participant Satisfaction

    Post curriculum session 2 (immediately after educational session 2, Day 7)

Interventions

A two-part interactive curriculum that will improve medication safety awareness and empower participants to engage in conversations with healthcare providers. The focus of this study will be to evaluate the impact of the MedSEC on patient/care-partner knowledge and medication management patient activation levels. A pre/post study that surveys older adults/caregivers pre-curriculum intervention and post-curriculum intervention, in addition to 6 months after program completion.

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and above
  • taking prescription medications
  • 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

You may not qualify if:

  • Patients with cognitive impairment that prevents their self-management of medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 142148033, United States

RECRUITING

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2025

First Posted

September 2, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations