NCT03052257

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 18, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

August 9, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 27, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 2, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

January 18, 2017

Results QC Date

July 29, 2020

Last Update Submit

May 1, 2024

Conditions

Glaucoma

Keywords

GlaucomaDisease managementSmart bottle

Outcome Measures

Primary Outcomes (1)

  • Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule

    Will veterans randomized to the intervention have a greater proportion of prescribed glaucoma medication doses taken as measured by the electronic medication monitor in the 6 months following the intervention compared to Veterans randomized to the control arm? The electronic bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through the electronic bottle will be activated. The outcome measure is the proportion of prescribed doses taken with a minimum of Zero and a maximum of One; where higher scores indicate more adherence.

    Randomization to 6 Months

Secondary Outcomes (1)

  • VA Medical Resource Use and Costs

    6 months

Other Outcomes (6)

  • Number of Participants With Newly Prescribed Glaucoma Therapy

    12 Months

  • Total Cost at 6 Months

    6 months

  • VA Healthcare Workflow Effectiveness

    12 months

  • +3 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will be randomized to receive either a general eye health educational session (control arm) or an educational intervention developed to improve glaucoma medication adherence (intervention arm). All 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.

Behavioral: Educational - glaucomaBehavioral: Dose monitoring and reminder

Control

ACTIVE COMPARATOR

Participants will be randomized to receive either a general eye health educational session (control arm) or an educational intervention developed to improve glaucoma medication adherence (intervention arm). All 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.

Behavioral: Educational - generalBehavioral: Dose monitoring

Interventions

Educational - glaucomaBEHAVIORAL

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).

Intervention
Dose monitoring and reminderBEHAVIORAL

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.

Also known as: Smart bottle reminder
Intervention
Educational - generalBEHAVIORAL

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

Control
Dose monitoringBEHAVIORAL

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.

Also known as: Smart bottle
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of open angle glaucoma \[primary open angle glaucoma, pigment dispersion glaucoma, pseudoexfoliation glaucoma, combined mechanism glaucoma, low tension glaucoma\] recorded in the medical record
  • Prescribed glaucoma eye drops,
  • Visual field performed within the last 9 months.
  • As visual field testing is standard care glaucoma and the investigators wish to establish baseline glaucoma severity, the investigators will require that subjects have a visual field test documented in the chart within 9 months of enrollment.

You may not qualify if:

  • "How confident are you that you always remember to use your glaucoma medications?"
  • not at all confident
  • somewhat confident
  • very confident)
  • And "In the past 4 weeks, did you ever forget to take your medicine?"
  • Veterans who respond both "very confident" and "no", respectively, will be excluded
  • Willing to participate in assisting the patient with glaucoma drops and
  • Willing to accompany the patient to the intervention visit for participants in the intervention arm or eye health education visit for participants in the control arm.
  • Lacks proficiency in English,
  • Lacks either a cell phone or landline phone.
  • Decision by patient and provider to cease glaucoma medication use
  • Change in functional status such that the drops are no longer administered by the patient or the companion (such as nursing home care)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (5)

  • Hein AM, Rosdahl JA, Bosworth HB, Woolson SL, Olsen MK, Kirshner MA, Muir KW. The Association of an Upper Extremity Functional Survey and Glaucoma Medication Administration Success. Curr Eye Res. 2019 Oct;44(10):1150-1156. doi: 10.1080/02713683.2019.1625405. Epub 2019 Jun 11.

    PMID: 31157555RESULT

  • Rosdahl JA, Hein AM, Bosworth HB, Woolson S, Olsen M, Kirshner M, Hung A, Muir KW. Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study. Clin Trials. 2021 Jun;18(3):343-350. doi: 10.1177/1740774520988291. Epub 2021 Jan 25.

    PMID: 33487050RESULT

  • Muir KW, Rosdahl JA, Hein AM, Woolson S, Olsen MK, Kirshner M, Sexton M, Bosworth HB. Improved Glaucoma Medication Adherence in a Randomized Controlled Trial. Ophthalmol Glaucoma. 2022 Jan-Feb;5(1):40-46. doi: 10.1016/j.ogla.2021.04.006. Epub 2021 Apr 20.

    PMID: 33892170RESULT

  • Williams AM, Theophanous C, Muir KW, Rosdahl JA, Woolson S, Olsen M, Bosworth HB, Hung A. Within-Trial Cost-Effectiveness of an Adherence-Enhancing Educational Intervention for Glaucoma. Am J Ophthalmol. 2022 Dec;244:216-227. doi: 10.1016/j.ajo.2022.08.011. Epub 2022 Aug 21.

    PMID: 36002073RESULT

  • Buehne KL, Rosdahl JA, Hein AM, Woolson S, Olsen M, Kirshner M, Sexton M, Bosworth HB, Muir KW. How Medication Adherence Affects Disease Management in Veterans with Glaucoma: Lessons Learned from a Clinical Trial. Ophthalmic Res. 2023;66(1):489-495. doi: 10.1159/000528857. Epub 2023 Jan 5.

    PMID: 36603568RESULT

Related Links

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Dr. Kelly Muir
Organization
Durham VA Medical Center, Durham, NC
Kelly.Muir@va.gov
919-286-0411

Study Officials

  • Kelly W. Muir, MD MHSc

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

February 14, 2017

Study Start

August 9, 2017

Primary Completion

August 1, 2019

Study Completion

March 1, 2021

Last Updated

May 2, 2024

Results First Posted

August 27, 2020

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

US(1)