The Role of Occupational Therapy for Improving Medication Management for Persons With AMD, DR and Glaucoma

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?

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.

Study Overview

• Status: Recruiting
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Combination product: occupational therapy interventions for low vision care

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Michelle Dowling, OTD; Phone Number: 508-373-5851; Email: michelle.dowling@mcphs.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01608
      • Recruiting
      • MCPHS 10 Lincoln Square
      • Contact: Michelle Dowling, Clinical Doctorate (OTD); Phone Number: 508-373-5851; Email: michelle.dowling@mcphs.edu
      • Principal Investigator: Michelle Dowling, Clinical Doctorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Receiving OT interventions; All participants will receive all OT interventions

Combination product: occupational therapy interventions for low vision care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MCPHS University
• Investigators: Principal Investigator: Michelle Dowling, OTD, MCPHS University

Publications and helpful links

General 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.

Helpful Links

• American Occupational Therapy Association link to professional information

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration
• Other Study ID Numbers: IRB-2023-2024-84

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results will be analyzed and results will be shared in the form of publication in a peer reviewed journal.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No