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

Early Phase 1

Recruiting

• Conditions: Age-Related Macular Degeneration
• Interventions: Combination Product: occupational therapy interventions for low vision care

• Registration Number: NCT06593405
• Lead Sponsor: MCPHS University

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.

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 Timeline

• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2025-04
• Study Start: 2025-04-22
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-12-05
• Study Completion: 2026-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Receiving OT interventions	occupational therapy interventions for low vision care	All participants will receive all OT interventions

Primary Outcome Measures

Name	Time	Method
Revised Self Report Assessment of Functional Visual	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	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.

Trial Locations

Locations (1)

MCPHS 10 Lincoln Square; 🇺🇸 Worcester, Massachusetts, United States