Dementiae-ALIGNNCT07454824
e-ALIGN: A Patient Portal-based Intervention to Align Medications With What Matters Most
A study testing e-ALIGN Patient-Portal Deprescribing in people with Dementia and Potentially Inappropriate Medication Use, run by Johns Hopkins University at 1 site in United States.
Trial summary
The overarching goal of this study is to pilot an intervention in which older adults with mild cognitive impairment and dementia and the older adult's care partners are identified in primary care and provided with educational materials through the patient portal to engage the participant in deprescribing. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Potentially Inappropriate Medication Use, Mild Cognitive Impairment (MCI)
- What is being tested?
- e-ALIGN Patient-Portal Deprescribing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 6 Feb 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients: Age ≥65, with a diagnosis of MCI or dementia based on ICD-10 codes and ≥1 active CNS-PIM, who are active patient portal users.
- Care partners:
- Family or other companions >21 years who regularly help the patient with managing medications.
Who cannot join
- As the trial will be based in primary care, individuals residing in long term care facilities or enrolled in hospice will be excluded.
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
Johns Hopkins Community Physicians
Baltimore, Maryland, 21209
Ariel Green, MD, MPH, PhD
410-550-6733, ariel@jhmi.edu
About this study
The overarching goal of this study is to pilot an intervention in which older adults with mild cognitive impairment and dementia and the older adult's care partners are identified in primary care and provided with educational materials through the patient portal to engage the participant in deprescribing. The multicomponent intervention, e-Align, includes delivery of educational information through the patient portal, and a pharmacist-led intervention to align medications with patient and care partner goals and reduce use of central nervous system (CNS) potentially inappropriate medicines (PIM). This work will establish the preliminary data, methods, and partnerships to undertake a multisite embedded pragmatic clinical trial. The resulting triadic-based behavioral intervention will promote patient and care partner engagement, and foster care that aligns with patients' values, and promote improved health and well-being outcomes for people with cognitive impairment and the patient's care partners through deprescribing.
- Being tested
- e-ALIGN Patient-Portal Deprescribing
- Keywords
- deprescribing, polypharmacy, potentially inappropriate medications, dementia, cognitive impairment
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-ALIGN Patient-Portal DeprescribingOther
The intervention will consist of educational materials about deprescribing, which will be sent to the patient prior to the scheduled primary care visit.
| Study group | Role | What they receive |
|---|---|---|
| Patient Portal Deprescribing Intervention | Experimental | e-ALIGN will be piloted via the patient portal. The intervention will provide patients and care partners with an educational video on the risks of Central Nervous System-Potentially Inappropriate Medications (CNS-PIM) through the patient portal, MyChart. It will also offer the participant the opportunity to discuss deprescribing options with the patient's primary care physician (PCP) or to receive a referral to discuss deprescribing options with a clinical pharmacist who is embedded in the primary care practice.
Patients who meet with the pharmacist will have two visits (intervention and follow-up). Patients who do not meet with a pharmacist will have a routine visit with the patient's PCP. Each participant will be on study (intervention period and additional follow-up) for approximately 3 months. Receives: Other: e-ALIGN Patient-Portal Deprescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who open the patient portal message
The investigators will assess the number of patients and/or care partners who read the patient portal message sent by the study team, which invites the participant to meet with a clinical pharmacist for deprescribing.
Measured: 1 month after sending message
Number of patients who watch the video
The investigators will assess the number of patients who click and watch the educational video about CNS-PIM and deprescribing.
Measured: 1 month after sending message
Acceptability of educational video assessed by survey
The investigators will assess the acceptability of the educational video by administering a survey to participants. The survey will ask participants to rate various features of the video on a 5-point Likert scale, where a higher score indicates greater acceptability.
Measured: 1 month after sending message
Secondary outcomes (5)
Number of patients or care partners that discussed deprescribing with any clinicians after receiving the message
Study team will follow up to assess if deprescribing was discussed with a clinician after receiving the patient portal message by conducting a review of patients' chart.
Measured: 3 months after sending message
Number of PCPs who send the referral
Study team will assess how many PCPs send a referral to clinical pharmacy for patients who have been identified as candidates for deprescribing.
Measured: 3 months after sending message
Number of patients who schedule the pharmacist visit
The investigators will determine the number of patients and/or care partners who schedule a visit with a clinical pharmacist for deprescribing CNS-PIM following receipt of the patient portal message.
Measured: 3 months after sending message
Number of patients who deprescribe ≥1 CNS-PIM after receiving the message
For those who do not schedule a pharmacist visit, the investigators will evaluate the number of patients who deprescribed at least 1 CNS-PIM after receiving the patient portal message.
Measured: 3 months after sending message (for patients who do NOT have a pharmacist visit)
Number of patients who start ≥1 CNS-PIM after receiving the message
For those who do not schedule a pharmacist visit, the investigators will evaluate the number of patients who add at least 1 CNS-PIM to the medication regimen after receiving the patient portal message.
Measured: 3 months after sending message (for people who do NOT have a pharmacist visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Apr 2026
- Primary completion6 Feb 2027 (estimated)
- Study completion6 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ariel Green, MD, MPH, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454824
- Sponsor's protocol ID
- IRB00506634
- Other IDs
- R01AG077011
- Acronym
- e-ALIGN
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-ALIGN: A Patient Portal-based Intervention to Align Medications With What Matters Most
- ClinicalTrials.gov ID
- NCT07454824
- Acronym / sponsor ID
- e-ALIGN / IRB00506634
- Keywords
- deprescribing, polypharmacy, potentially inappropriate medications, dementia, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 6 Feb 2027 (estimated)
- Study completion
- 6 Feb 2027 (estimated)
- First posted
- 6 Mar 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.
The overarching goal of this study is to pilot an intervention in which older adults with mild cognitive impairment and dementia and the older adult's care partners are identified in primary care and provided with educational materials through the patient portal to engage the participant in deprescribing. The multicomponent intervention, e-Align, includes delivery of educational information through the patient portal, and a pharmacist-led intervention to align medications with patient and care partner goals and reduce use of central nervous system (CNS) potentially inappropriate medicines (PIM). This work will establish the preliminary data, methods, and partnerships to undertake a multisite embedded pragmatic clinical trial. The resulting triadic-based behavioral intervention will promote patient and care partner engagement, and foster care that aligns with patients' values, and promote improved health and well-being outcomes for people with cognitive impairment and the patient's care partners through deprescribing.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Portal Deprescribing Intervention | Experimental | Other: e-ALIGN Patient-Portal Deprescribinge-ALIGN will be piloted via the patient portal. The intervention will provide patients and care partners with an educational video on the risks of Central Nervous System-Potentially Inappropriate Medications (CNS-PIM) through the patient portal, MyChart. It will also offer the participant the opportunity to discuss deprescribing options with the patient's primary care physician (PCP) or to receive a referral to discuss deprescribing options with a clinical pharmacist who is embedded in the primary care practice. Patients who meet with the pharmacist will have two visits (intervention and follow-up). Patients who do not meet with a pharmacist will have a routine visit with the patient's PCP. Each participant will be on study (intervention period and additional follow-up) for approximately 3 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients: Age ≥65, with a diagnosis of MCI or dementia based on ICD-10 codes and ≥1 active CNS-PIM, who are active patient portal users.
- Family or other companions >21 years who regularly help the patient with managing medications.
Key exclusion criteria (1 listed)
- As the trial will be based in primary care, individuals residing in long term care facilities or enrolled in hospice will be excluded.
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 |
|---|---|---|
| e-ALIGN Patient-Portal DeprescribingThe intervention will consist of educational materials about deprescribing, which will be sent to the patient prior to the scheduled primary care visit. | Other | Patient Portal Deprescribing Intervention |
Primary outcome
Number of patients who open the patient portal message
Time frame: 1 month after sending message
The investigators will assess the number of patients and/or care partners who read the patient portal message sent by the study team, which invites the participant to meet with a clinical pharmacist for deprescribing.
Number of patients who watch the video
Time frame: 1 month after sending message
The investigators will assess the number of patients who click and watch the educational video about CNS-PIM and deprescribing.
Acceptability of educational video assessed by survey
Time frame: 1 month after sending message
The investigators will assess the acceptability of the educational video by administering a survey to participants. The survey will ask participants to rate various features of the video on a 5-point Likert scale, where a higher score indicates greater acceptability.
5 secondary outcomes
Number of patients or care partners that discussed deprescribing with any clinicians after receiving the message
Time frame: 3 months after sending message
Number of PCPs who send the referral
Time frame: 3 months after sending message
Number of patients who schedule the pharmacist visit
Time frame: 3 months after sending message
Number of patients who deprescribe ≥1 CNS-PIM after receiving the message
Time frame: 3 months after sending message (for patients who do NOT have a pharmacist visit)
Number of patients who start ≥1 CNS-PIM after receiving the message
Time frame: 3 months after sending message (for people who do NOT have a pharmacist visit)
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 16 Jun 2026.
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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.
Ariel Green, MD, MPH, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-ALIGN Patient-Portal Deprescribing in people with Dementia and Potentially Inappropriate Medication Use, run by Johns Hopkins University 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 3 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 16 Jun 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?
Contact Ariel Green, MD, MPH, PhD (410-550-6733, ariel@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who open the patient portal message (time frame: 1 month after sending message). The study lists 3 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 16 Jun 2026.