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Improve Glaucoma Medication Adherence (MAGIC)

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ClinicalTrials.gov Identifier: NCT03052257
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Glaucoma Behavioral: Educational - glaucoma Behavioral: Dose monitoring and reminder Behavioral: Educational - general Behavioral: Dose monitoring Not Applicable

Detailed Description:

The purpose if this study is to improve glaucoma medication adherence in Veterans with medically-treated glaucoma. The study design is a single-site randomized controlled trial. Specific Aim 1. Evaluate the impact of an intervention to improve glaucoma medication adherence among Veterans at 6-month follow up.

Hypothesis 1: Veterans randomized to the intervention will 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 primary outcome for hypothesis 1A is the proportion of prescribed doses taken according to the electronic monitor. Participants in both arms will receive the electronic monitor or "smart bottle," which wirelessly transmits the date and time of opening of the smart bottle to the study team. From these medication events, the proportion of prescribed doses will be derived, defined as the ratio of the number of times the smart bottle was opened to the required number of doses prescribed according to the medical record over the period of time that the bottle is in use. For example, if a participant is advised to take his or her glaucoma drop twice a day for the 180 days that the bottle is in use and the smart bottle reveals 135 openings over the same time period, the proportion of prescribed doses taken is 37.5%.

Specific Aim 2. Evaluate the impact of the intervention on intensification of glaucoma therapy among Veterans at 12-month follow-up.

Hypothesis 2: The proportion of Veterans in the intervention arm that are prescribed more intensive glaucoma therapy, defined as addition of adjuvant glaucoma medication or recommendation for laser or glaucoma surgery will be less than the proportion of Veterans in the control arm who are prescribed more intensive glaucoma therapy in the 12 months following the intervention.

Baseline data collection will include cataloging the current glaucoma medication regimen prescribed to the participant. Chart abstractions will be performed at 12 months following the baseline visit and intensification of glaucoma therapy will be defined as either 1) the addition of another glaucoma medication to the baseline regimen, 2) recommendation for glaucoma laser treatment, or 3) recommendation for glaucoma surgery in the 12 months following the baseline visit . The investigators will collect these data at 12 months because the Metrics study suggested that 55% of participants in the control arm will have intensification of therapy within one year.

Specific Aim 3. Evaluate the incremental cost-effectiveness and budget and workflow impacts of the intervention compared to usual care.

Hypothesis 3: The intervention will be cost-effectiveness for the following ratios: 1) cost per percentage improvement in medication adherence; 2) cost per blindness averted; and 3) cost per quality-adjusted-life years saved.

A direct measurement approach will be used to estimate per-patient intervention and control arm costs. Glaucoma-related health care utilization costs will be derived from VA administrative datasets. The cost estimates will be combined with observed improvement in medication adherence and reduction in escalation in therapy to estimate the first two incremental cost effectiveness ratios. Simulation using Markov modeling will be used to estimate the incremental cost per blindness averted and quality-adjusted life years (QALYs) gained. Cost estimates and labor time data collected will be combined with glaucoma prevalence rates among Veterans to estimate overall budget and workload impacts to the VA healthcare system.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Glaucoma Medication Adherence
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Intervention
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 - 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.
Other Name: Smart bottle reminder

Active Comparator: Control
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 - 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.
Other Name: Smart bottle




Primary Outcome Measures :
  1. Electronic bottle monitoring of medication adherence [ Time Frame: 6 Months ]
    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.


Other Outcome Measures:
  1. Evaluation of newly prescribed glaucoma therapy [ Time Frame: 12 Months ]
    Will the proportion of Veterans in the intervention arm that are prescribed more intensive glaucoma therapy be less than the proportion of Veterans in the control arm who are prescribed more intensive glaucoma therapy in the 12 months following the intervention? Baseline data collection will include cataloging the current glaucoma medication regimen prescribed to the participant. Chart abstractions will be performed at 12 months following the baseline visit and intensification of glaucoma therapy will be defined as either 1) the addition of another glaucoma medication to the baseline regimen, 2) recommendation for glaucoma laser treatment, or 3) recommendation for glaucoma surgery in the 12 months following the baseline visit .

  2. Cost-effectiveness [ Time Frame: 12 months ]
    Will the intervention be cost-effectiveness compared to usual care for cost per percentage improvement in medication adherence

  3. VA Budget Impacts [ Time Frame: 12 months ]
    The investigators will investigate the overall budget impacts to the VA healthcare system.

  4. VA healthcare workflow effectiveness [ Time Frame: 12 months ]
    The investigators will investigate the overall workload impacts to the VA healthcare system. Cost estimates and labor time data collected will be combined with glaucoma prevalence rates among Veterans to estimate overall workload impacts to the VA healthcare system.

  5. Cost-effectiveness [ Time Frame: 12 months ]
    Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted

  6. Cost-effectiveness [ Time Frame: 12 months ]
    Will the intervention be cost-effectiveness compared to usual care for cost per quality-adjusted-life years saved?

  7. VA Workflow Effectiveness [ Time Frame: 12 months ]
    The investigators will investigate the overall workload impacts to the VA healthcare system.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Exclusion criteria for patients At Screener:

  • "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

Inclusion criteria for companions at screener:

  • 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.

Exclusion criteria for companions: Unable or unwilling to attend baseline visit and intervention or control arm educational session with patient participant.

Exclusion criteria for patients or companions:

  • Lacks proficiency in English,
  • Lacks either a cell phone or landline phone.

Exclusion criteria for patients post randomization:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052257


Contacts
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Contact: Miriam Kirshner, MSW (919) 286-0411 ext 4018 Miriam.Kirshner@va.gov
Contact: Kelly W Muir, MD MHSc (919) 286-6936 Kelly.Muir@va.gov

Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705
Contact: Miriam Kirshner, MSW    919-286-0411 ext 4018    Miriam.Kirshner@va.gov   
Sub-Investigator: Hayden B Bosworth, PhD         
Principal Investigator: Kelly W. Muir, MD MHSc         
Sub-Investigator: Maren K Olsen, PhD         
Sub-Investigator: Matthew L Maciejewski, PhD         
Sub-Investigator: Sharon Fekrat, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Kelly W. Muir, MD MHSc Durham VA Medical Center, Durham, NC

Additional Information:
Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03052257     History of Changes
Other Study ID Numbers: IIR 15-113
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
Glaucoma
Disease management
Smart bottle

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases