Evaluation of a Scalable Educational Intervention for Adjustment and Coping to Vision Loss

July 16, 2026 updated by: Ali S Raza, MD, PhD, Brigham and Women's Hospital

The goal of this interventional study is to learn if an educational intervention improves awareness in people experiencing visual loss. The main question it aim to answer is:

  • Will participants have an improved awareness of shared experiences regarding themes such as grief and isolation?

Participants will be asked to answer questions, engage with an audiovisual educational intervention, and then answer additional questions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • New England College of Optometry
        • Principal Investigator:
          • Micaela Gobeille, OD, MS, FAAO, Dipl AAO LV
        • Sub-Investigator:
          • Nicole Ross, OD, MSc, FAAO, Dipl AAO LV
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital, Mass General Brigham
        • Principal Investigator:
          • Ali S Raza, MD, PhD
        • Sub-Investigator:
          • Pamela B Mahon, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • have capacity to provide informed consent
  • have had a visit within a low-vision rehabilitation clinic

Exclusion Criteria:

  • are unable to engage with the audiovisual educational intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational Intervention Arm
Other: audiovisual educational intervention
A brief audiovisual educational intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Educational Awareness of Shared Themes as Measured by Likert-scale Questions
Time Frame: From baseline to completion of post-intervention questions (e.g., within 1 week).
Higher values (or increases relative to baseline) correspond to better outcomes, with each question having a minimum value of 1 and a maximum value of 5.
From baseline to completion of post-intervention questions (e.g., within 1 week).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Screening Measures of Depression and Anxiety as Measured by the Patient Health Questionnaire 4 (PHQ-4)
Time Frame: From baseline to completion of post-intervention questions (e.g., within 1 week).
Lower values (or decreases relative to baseline) correspond to better outcomes, with each question having a minimum value of 0 and a maximum value of 3.
From baseline to completion of post-intervention questions (e.g., within 1 week).
Change from Baseline of Vision-Related Wellbeing as Measured by the Visual Function Questionnaire 25 (VFQ-25) Socioemotional Wellbeing Subscale
Time Frame: From baseline to completion of post-intervention questions (e.g., within 1 week).
From baseline to completion of post-intervention questions (e.g., within 1 week).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

New England College of Optometry
Hadley Foundation, Inc.

Investigators

  • Principal Investigator: Ali S Raza, MD, PhD, Brigham and Women's Hospital, Mass General Brigham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P001151
  • HADLEY-RFA-2026-01 (Other Grant/Funding Number: Hadley Foundation, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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