Improve Glaucoma Medication Adherence

NCT03052257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-05-02

Study results available
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Summary

The proposed study is a randomized controlled trial enrolling Veterans with medically treated glaucoma who report less than 100% adherence to the prescribed glaucoma therapy. Participants will be randomized to receive either a one-on-one session with a member of the research team discussing the disease process and strategies for administering eye drops (intervention) or a one-on-one session with a member of the research team discussing general eye health (control). All participants will be provided with a "smart bottle" to house their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder function will be activated. The proportion or prescribed doses taken according to the monitor will be compared for the two groups.

Conditions

Interventions

BEHAVIORAL

Educational - glaucoma

Discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, Provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation. An individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES).

BEHAVIORAL

Dose monitoring and reminder

Participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through AdhereTech will be activated.

BEHAVIORAL

Educational - general

The control information session will include review of a Powerpoint presentation on general eye health, including but not specific to glaucoma.

BEHAVIORAL

Dose monitoring

Participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Kelly W. Muir, MD MHSc · Durham VA Medical Center, Durham, NC

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-09
Primary Completion
2019-08-01
Completion
2021-03-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052257 on ClinicalTrials.gov