MAGIC: Improve Glaucoma Medication Adherence

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03052257
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 42.7
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 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: Aug 9, 2017
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

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 Names: 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 Names: Smart bottle

Outcome Measures

Primary Outcome Measures

1. Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule [Randomization to 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. 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.

Other Outcome Measures

1. Evaluation of Newly Prescribed Glaucoma Therapy [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 Compared to Usual Care for Cost Per Percentage Improvement in Medication Adherence [12 months]

   Will the intervention be cost-effectiveness compared to usual care for cost per percentage improvement in medication adherence

3. VA Budget Impacts [12 months]

   The investigators will investigate the overall budget impacts to the VA healthcare system.

4. VA Healthcare Workflow Effectiveness [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 Compared to Usual Care for Cost Per Blindness Averted [12 months]

   Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted

6. Cost-effectiveness Compared to Usual Care for Cost Per Quality-adjusted-life Years Saved. [12 months]

   Will the intervention be cost-effectiveness compared to usual care for cost per quality-adjusted-life years saved?

7. VA Workflow Effectiveness [12 months]

   The investigators will investigate the overall workload impacts to the VA healthcare system.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Kelly W. Muir, MD MHSc, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 9, 2018

More Information

Additional Information:

• Intervention Arm Content Video testimonial from a glaucoma patient

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03052257
• Other Study ID Numbers: IIR 15-113
• First Posted: Feb 14, 2017
• Last Update Posted: Apr 22, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Glaucoma

Study Results

Participant Flow

Arm/Group Title	Intervention	Control
Arm/Group Description	Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a 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). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.	Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.
Period Title: Overall Study
STARTED	100	100
COMPLETED	95	97
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a 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). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.	Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.	Total of all reporting groups
Overall Participants	100	100	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.9 (8.6)	67.1 (8.1)	67.5 (8.33)
Sex: Female, Male (Count of Participants)
Female	4 4%	9 9%	13 6.5%
Male	96 96%	91 91%	187 93.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 10%	4 4%	14 7%
Not Hispanic or Latino	90 90%	96 96%	186 93%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 3%	4 4%	7 3.5%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	1 1%	1 0.5%
Black or African American	66 66%	73 73%	139 69.5%
White	30 30%	21 21%	51 25.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 1%	1 1%	2 1%
Region of Enrollment (Count of Participants)
United States	100 100%	100 100%	200 100%
Doses Per Day of Monitored Medication (Count of Participants)
One Dose Per Day	44 44%	43 43%	87 43.5%
More Than One Dose Per Day	56 56%	57 57%	113 56.5%
Companion Status (Count of Participants)
Companion at Randomization	20 20%	21 21%	41 20.5%
No Companion at Randomization	80 80%	79 79%	159 79.5%

Outcome Measures

1. Primary Outcome

Title	Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule
Description	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.
Time Frame	Randomization to 6 Months

Outcome Measure Data

Analysis Population Description

95 Intervention: Of the 100 randomized to Intervention - 2 subjects withdrew after randomization and 3 subjects excluded for not having at least 25 weeks of adherence data 97 Control: Of the 100 randomized to Control - 1 subject excluded by PI for not taking medication and 2 subjects excluded for not having at least 25 weeks of adherence data

Arm/Group Title	Intervention	Control
Arm/Group Description	Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a 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). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.	Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.
Measure Participants	95	97
Least Squares Mean (95% Confidence Interval) [proportion of doses]	.84	0.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95%; 0.15 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04
	Estimation Comments

2. Other Pre-specified Outcome

Title	Evaluation of Newly Prescribed Glaucoma Therapy
Description	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 .
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Other Pre-specified Outcome

Title	Cost-effectiveness Compared to Usual Care for Cost Per Percentage Improvement in Medication Adherence
Description	Will the intervention be cost-effectiveness compared to usual care for cost per percentage improvement in medication adherence
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	VA Budget Impacts
Description	The investigators will investigate the overall budget impacts to the VA healthcare system.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	VA Healthcare Workflow Effectiveness
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Cost-effectiveness Compared to Usual Care for Cost Per Blindness Averted
Description	Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Cost-effectiveness Compared to Usual Care for Cost Per Quality-adjusted-life Years Saved.
Description	Will the intervention be cost-effectiveness compared to usual care for cost per quality-adjusted-life years saved?
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	VA Workflow Effectiveness
Description	The investigators will investigate the overall workload impacts to the VA healthcare system.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	12 months
Arm/Group Title	Intervention		Control
Arm/Group Description	Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a 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). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.		Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/100 (4%)		2/100 (2%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/100 (3%)		2/100 (2%)
General disorders
Death	3/100 (3%)	3	2/100 (2%)	2
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/100 (1%)		0/100 (0%)
Vascular disorders
Hospitalization	1/100 (1%)	1	0/100 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.