NCT06593405

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
7mo left

Started Apr 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

August 26, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

April 22, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2026

Last Updated

September 29, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

August 26, 2024

Last Update Submit

September 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Results from the MediCog will be determined on day 1 and will be obtained 4 weeks later

Study Arms (1)

Receiving OT interventions

EXPERIMENTAL

All participants will receive all OT interventions

Combination Product: occupational therapy interventions for low vision care

Interventions

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.

Receiving OT interventions

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clients with AMD, DR or Glaucoma
  • Clients who choose to participate will allow their deidentified data to be evaluated for outcomes.

You may not qualify if:

  • Clients with other age related eye diseases other than AMD, DR or Glaucoma.
  • Clients who do not wish to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MCPHS 10 Lincoln Square

Worcester, Massachusetts, 01608, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29309002BACKGROUND

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Michelle Dowling, OTD

    MCPHS University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Dowling, OTD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2024

First Posted

September 19, 2024

Study Start

April 22, 2025

Primary Completion (Estimated)

December 5, 2026

Study Completion (Estimated)

December 5, 2026

Last Updated

September 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Results will be analyzed and results will be shared in the form of publication in a peer reviewed journal.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 months after publication

Locations