Age-Related Macular DegenerationEarly Phase 1NCT06593405
The Role of Occupational Therapy for Improving Medication Management for Persons With AMD, DR and Glaucoma
A Early Phase 1 study testing occupational therapy interventions for low vision care in people with Age-Related Macular Degeneration, run by MCPHS University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if education about additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies will improve medication management skills. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- occupational therapy interventions for low vision care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 5 Dec 2026
- Phase
- Early Phase 1
- 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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clients with AMD, DR or Glaucoma
- Clients who choose to participate will allow their deidentified data to be evaluated for outcomes.
Who cannot join
- Clients with other age related eye diseases other than AMD, DR or Glaucoma.
- Clients who do not wish to participate in this study.
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
MCPHS 10 Lincoln Square
Worcester, Massachusetts, 01608
Michelle Dowling, Clinical Doctorate (OTD), 508-373-5851, michelle.dowling@mcphs.edu
Michelle Dowling, Clinical Doctorate
About this study
Official title: The Role of Occupational Therapy for Improving Medication Management for Persons With AMD, Diabetic Retinopathy (DR) and Glaucoma
The goal of this clinical trial is to learn if education about additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies will improve medication management skills. The main questions it aims to answer are:
Does additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies improve medication management skills, reduce errors and improve functional use of remaining vision for this task?
Read more
Participants will:
Oftentimes, the client is unaware of these strategies which may improve occupational performance during a valued activity. Clients with AMD, DR or Glaucoma who choose to receive the one hour OT service will be provided with 1:1 education regarding the devices and strategies that may improve their ability to perform medication management skills.
Read the detailed description
Many clients with low vision are unaware of OT, or the services OT can provide to assist with low vision needs. Clients with AMD, DR or Glaucoma who choose to receive the one hour OT service will be provided with 1:1 education regarding the devices and strategies that may improve their ability to perform medication management skills. Clients will complete the MediCog and the Revised-Self-Report Assessment of Functional Visual Performance (R-SRAFVP) assessment tools with the assistance of the OT. These tools will inform the therapist to areas of client needs and allow for focus on intervention to support these challenges. Follow up in OT 4 weeks post intervention will allow therapist to reassess the effectiveness of interventions provided via a phone or in-person interview as well as provide the assessments again. Second set of data from these assessments will be compared to initial findings obtained.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- occupational therapy interventions for low vision care
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapy interventions for low vision careCombination product
Occupational therapists utilize many different treatment strategies when caring for the client with low vision. Oftentimes, the client is unaware of these strategies which may improve occupational performance during a valued activity. Interventions include task lighting, organizational strategies, smart apps, contrast, enlarged print, typoscopes and electronic magnification devices.
| Study group | Role | What they receive |
|---|---|---|
| Receiving OT interventions | Experimental | All participants will receive all OT interventions Receives: Combination Product: occupational therapy interventions for low vision care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Self Report Assessment of Functional Visual
A standardized assessment which provides information on how well adults with vision loss can perform daily tasks. This tool has 33 assessment components and a higher score indicates less functional impairment. A lower score indicates a higher impairment.
Measured: Results from the Revised-Self-Report Assessment of Functional Visual Performance assessment will be determined on day 1 and 4 weeks later
MediCog Screening Tool
The Medi-Cog has a maximum score of 10 points, and a score of 7 or lower may indicate cognitive impairment.
Measured: Results from the MediCog will be determined on day 1 and will be obtained 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Apr 2025
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a quasi-experimental study to determine outcomes with occupational therapy (OT) medication management interventions/strategies for persons with Age-related Macular Degeneration (AMD)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MCPHS University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Dowling, OTD, Principal investigator, MCPHS University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593405
- Sponsor's protocol ID
- IRB-2023-2024-84
- Status last verified
- May 2026
- First submitted
- 26 Aug 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be analyzed and results will be shared in the form of publication in a peer reviewed journal.
Publications
Occupational Therapy's Role in Medication Management. Am J Occup Ther. 2017 Nov/Dec;71(Supplement_2):7112410025p1-7112410025p20. doi: 10.5014/ajot.2017.716S02. No abstract available.
PubMed 29309002
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Occupational Therapy for Improving Medication Management for Persons With AMD, Diabetic Retinopathy (DR) and Glaucoma
- ClinicalTrials.gov ID
- NCT06593405
- Acronym / sponsor ID
- IRB-2023-2024-84
- Conditions
- Age-Related Macular Degeneration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MCPHS UniversityUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to learn if education about additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies will improve medication management skills. The main questions it aims to answer are:
Does additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies improve medication management skills, reduce errors and improve functional use of remaining vision for this task?
Participants will:
Oftentimes, the client is unaware of these strategies which may improve occupational performance during a valued activity. Clients with AMD, DR or Glaucoma who choose to receive the one hour OT service will be provided with 1:1 education regarding the devices and strategies that may improve their ability to perform medication management skills.
Detailed description
Many clients with low vision are unaware of OT, or the services OT can provide to assist with low vision needs. Clients with AMD, DR or Glaucoma who choose to receive the one hour OT service will be provided with 1:1 education regarding the devices and strategies that may improve their ability to perform medication management skills. Clients will complete the MediCog and the Revised-Self-Report Assessment of Functional Visual Performance (R-SRAFVP) assessment tools with the assistance of the OT. These tools will inform the therapist to areas of client needs and allow for focus on intervention to support these challenges. Follow up in OT 4 weeks post intervention will allow therapist to reassess the effectiveness of interventions provided via a phone or in-person interview as well as provide the assessments again. Second set of data from these assessments will be compared to initial findings obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a quasi-experimental study to determine outcomes with occupational therapy (OT) medication management interventions/strategies for persons with Age-related Macular Degeneration (AMD)
| Arm | Type | Receives |
|---|---|---|
| Receiving OT interventions | Experimental | Combination Product: occupational therapy interventions for low vision careAll participants will receive all OT interventions |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clients with AMD, DR or Glaucoma
- Clients who choose to participate will allow their deidentified data to be evaluated for outcomes.
Key exclusion criteria (2 listed)
- Clients with other age related eye diseases other than AMD, DR or Glaucoma.
- Clients who do not wish to participate in this study.
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 |
|---|---|---|
| occupational therapy interventions for low vision careOccupational therapists utilize many different treatment strategies when caring for the client with low vision. Oftentimes, the client is unaware of these strategies which may improve occupational performance during a valued activity. Interventions include task lighting, organizational strategies, smart apps, contrast, enlarged print, typoscopes and electronic magnification devices. | Combination product | Receiving OT interventions |
Primary outcome
Revised Self Report Assessment of Functional Visual
Time frame: Results from the Revised-Self-Report Assessment of Functional Visual Performance assessment will be determined on day 1 and 4 weeks later
A standardized assessment which provides information on how well adults with vision loss can perform daily tasks. This tool has 33 assessment components and a higher score indicates less functional impairment. A lower score indicates a higher impairment.
MediCog Screening Tool
Time frame: Results from the MediCog will be determined on day 1 and will be obtained 4 weeks later
The Medi-Cog has a maximum score of 10 points, and a score of 7 or lower may indicate cognitive impairment.
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 12 May 2026.
- Background: PubMed 29309002Occupational Therapy's Role in Medication Management. Am J Occup Ther. 2017 Nov/Dec;71(Supplement_2):7112410025p1-7112410025p20. doi: 10.5014/ajot.2017.716S02. No abstract available.
- American Occupational Therapy Association link to professional informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results will be analyzed and results will be shared in the form of publication in a peer reviewed journal.
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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.
Michelle Dowling, OTD principal investigator
MCPHS University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing occupational therapy interventions for low vision care in people with Age-Related Macular Degeneration, run by MCPHS 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 2 inclusion and 2 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 12 May 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Michelle Dowling, OTD (508-373-5851, michelle.dowling@mcphs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Self Report Assessment of Functional Visual (time frame: Results from the Revised-Self-Report Assessment of Functional Visual Performance assessment will be determined on day 1 and 4 weeks later). 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?
On the ClinicalTrials.gov record for NCT06593405, which also lists 1 linked publication.
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 12 May 2026.