Older AdultsNCT07799610
Senior Center Medication Safety and Empowerment Curriculum
A study testing Team Alice Medication Safety and Empowerment Curriculum (MedSEC) in people with Older Adults and Medication and Supplement Use, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Older Adults, Medication and Supplement Use, Caregiver Awareness
- What is being tested?
- Team Alice Medication Safety and Empowerment Curriculum (MedSEC)
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with cognitive impairment that prevents their self-management of medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo
Buffalo, New York, 142148033
Robert G Wahler, Doctor of Pharmacy, 7166454777, rgwahler@buffalo.edu
Robert G Wahler, Doctor of Pharmacy
About this study
Official title: 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.
- Conditions
- Older Adults, Medication and Supplement Use, Caregiver Awareness, Health Literacy, Empowerment, Patient, Knowledge
- Being tested
- Team Alice Medication Safety and Empowerment Curriculum (MedSEC)
- Keywords
- older adult, patient education, caregiver education, medication safety, patient knowledge, patient empowerment
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team Alice Medication Safety and Empowerment Curriculum (MedSEC)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
6 months post-program, 65% of participants will show improved patient engagement, as measured by the Patient Activation Measure (PAM) questionnaire.
Measured: 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
Within 6 months of completing program, 50% of participants with polypharmacy will have reduced medication usage by 10%. (mean # of medications.)
Measured: Change from baseline and 6 months after program completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Health Foundation for Western and Central New York
- Responsible party
- Principal investigator, Robert Wahler, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799610
- Sponsor's protocol ID
- STUDY00009882
- Other IDs
- G-202509-02155
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team Alice Senior Center Medication Safety and Empowerment Curriculum
- ClinicalTrials.gov ID
- NCT07799610
- Acronym / sponsor ID
- STUDY00009882
- Conditions
- Older Adults, Medication and Supplement Use, Caregiver Awareness, Health Literacy, Empowerment, Patient, Knowledge
- Keywords
- older adult, patient education, caregiver education, medication safety, patient knowledge, patient empowerment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Health Foundation for Western and Central New York
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 55 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
Key exclusion criteria (1 listed)
- Patients with cognitive impairment that prevents their self-management of medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team Alice Medication Safety and Empowerment Curriculum (MedSEC)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. | Other | – |
Primary outcome
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).
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.
4 secondary outcomes
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.
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.
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.
Change from baseline in the mean of medications after 6 months follow-up
Time frame: Change from baseline and 6 months after program completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team Alice Medication Safety and Empowerment Curriculum (MedSEC) in people with Older Adults and Medication and Supplement Use, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.