Pharmacist-led intervention to reduce unnecessary medications in dementia patients
Demonstration of ALIGN: Aligning Medications With What Matters Most
NA · Johns Hopkins University · NCT06335953
This study tests if working with a pharmacist can help people with dementia and their caregivers safely reduce unnecessary medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06335953 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a pharmacist-led de-prescribing intervention for individuals living with dementia and their care partners. The intervention includes an educational brochure, a telehealth visit with a clinical pharmacist to discuss medication benefits and harms, and tailored recommendations for primary care providers. Participants will be compared to a waitlist control group to assess the proportion of patients who successfully deprescribe at least one medication within three months. The study addresses the challenges of polypharmacy and inappropriate medication use in dementia care.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older with a diagnosis of dementia who are taking five or more medications.
Not a fit: Patients residing in long-term care facilities or enrolled in hospice may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to safer medication regimens and improved quality of life for patients with dementia.
How similar studies have performed: Previous studies have shown that deprescribing certain medications in older adults can be safe and beneficial, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥65 years * Diagnosis of dementia from International Classification of Diseases (ICD-10) visit codes or from the EHR problem list * Five or more medications * Only active patients, defined as having \>1 visit to the primary care clinic within the past year will be included Care partners: * Family or other companions \>21 years old who regularly help the patient manage medications. Exclusion Criteria: * As the pragmatic trial will be based on primary care, individuals residing in long-term care facilities or enrolled in hospice will be excluded. * Participants must hear well enough to communicate by telephone in English.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Community Physicians — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Ariel Green, MD, MPH, PhD — Johns Hopkins University
- Study coordinator: Ariel Green, MD, MPH, PhD
- Email: ariel@jhmi.edu
- Phone: 410-550-6733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Polypharmacy, Alzheimer's Disease and Related Dementias, Mild Cognitive Impairment, Deprescribing