Trial Outcomes & Findings for Improve Glaucoma Medication Adherence (NCT NCT03052257)

Last Updated: 2024-05-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

Randomization to 6 Months

Results posted on

2024-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention 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.	Control 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.
Overall Study STARTED	100	100
Overall Study COMPLETED	95	97
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improve Glaucoma Medication Adherence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=100 Participants 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.	Control n=100 Participants 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 n=200 Participants Total of all reporting groups
Age, Continuous	67.9 years STANDARD_DEVIATION 8.6 • n=5 Participants	67.1 years STANDARD_DEVIATION 8.1 • n=7 Participants	67.5 years STANDARD_DEVIATION 8.33 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	91 Participants n=7 Participants	187 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants	96 Participants n=7 Participants	186 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	66 Participants n=5 Participants	73 Participants n=7 Participants	139 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	21 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Doses Per Day of Monitored Medication One Dose Per Day	44 Participants n=5 Participants	43 Participants n=7 Participants	87 Participants n=5 Participants
Doses Per Day of Monitored Medication More Than One Dose Per Day	56 Participants n=5 Participants	57 Participants n=7 Participants	113 Participants n=5 Participants
Companion Status Companion at Randomization	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Companion Status No Companion at Randomization	80 Participants n=5 Participants	79 Participants n=7 Participants	159 Participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to 6 Months

Population: 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

Outcome measures

Outcome measures
Measure	Intervention n=95 Participants 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.	Control n=97 Participants 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.
Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule	.84 proportion of doses Interval 0.78 to 0.9	0.62 proportion of doses Interval 0.56 to 0.67

SECONDARY outcome

Timeframe: 6 months

Population: 100 Intervention 100 Control

The investigators will investigate the overall budget impacts to the VA healthcare system. The main intervention costs are labor inputs, consisting of the one-time fixed labor cost of training and the variable labor cost of conducting the adherence intervention. The VA healthcare system also incurs costs, such as administration, utilities, and custodial services that cannot be directly attributed to a given health care service but nonetheless should be included in the cost analysis.

Outcome measures

Outcome measures
Measure	Intervention n=100 Participants 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.	Control n=100 Participants 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.
VA Medical Resource Use and Costs	10947 USD Standard Deviation 19341	12939 USD Standard Deviation 25199

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: 200 randomized Veterans who are patients of the Durham VA Eye Clinic with medically-treated glaucoma.

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 .

Outcome measures

Outcome measures
Measure	Intervention n=100 Participants 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.	Control n=100 Participants 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.
Number of Participants With Newly Prescribed Glaucoma Therapy	23 Participants	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: 100 Intervention (hypothetical cohort) 100 Control (hypothetical cohort)

The proportion of participants attaining equal or \>80% adherence as measured by electronic monitor, total intervention and medical resource costs, and incremental cost effectiveness ratios comparing intervention to control at 6 months.

Outcome measures

Outcome measures
Measure	Intervention n=100 Participants 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.	Control n=100 Participants 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 Cost at 6 Months	1,149,600 USD	1,298,700 USD

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Workflow changed significantly over the course of the study such that this outcome became not feasible to assess. Over the time that participants were enrolled, we had multiple staff and doctor changes, not to mention the pandemic.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: While the long-term goal of this research program is to reduce glaucoma-related blindness in Veterans; in the course of the study period no participants went blind. We were unable to calculate this hypothesized outcome.

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Will the intervention be cost-effectiveness compared to usual care? Total cost was calculated by adding the mean medical resource cost per patient to the cost of the intervention ($549) or the control ($48), then multiplying the total by the number of patients per group (100)

Outcome measures

Outcome measures
Measure	Intervention n=100 Participants 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.	Control n=100 Participants 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.
Within-Trial Cost-Effectiveness of Adherence	1,149,600 USD	1,298,700 USD

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

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

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 3 serious events

Other events: 1 other events

Deaths: 4 deaths

Control

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=100 participants at risk 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.	Control n=100 participants at risk 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.
General disorders Death	3.0% 3/100 • Number of events 3 • 12 months	2.0% 2/100 • Number of events 2 • 12 months

Other adverse events

Other adverse events
Measure	Intervention n=100 participants at risk 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.	Control n=100 participants at risk 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.
Vascular disorders Hospitalization	1.0% 1/100 • Number of events 1 • 12 months	0.00% 0/100 • 12 months

Additional Information

Dr. Kelly Muir

Durham VA Medical Center, Durham, NC

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place