Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational - glaucoma | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VA Medical Resource Use and Costs | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Newly Prescribed Glaucoma Therapy | 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 . |
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.
Exclusion Criteria:
Exclusion criteria for patients At Screener:
"How confident are you that you always remember to use your glaucoma medications?"
And "In the past 4 weeks, did you ever forget to take your medicine?"
Inclusion criteria for companions at screener:
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:
Exclusion criteria for patients post randomization:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kelly W. Muir, MD MHSc | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31157555 | Result | 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. | |
| 33487050 | Result | 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. |
| Label | URL |
|---|---|
| Intervention Arm Content Video testimonial from a glaucoma patient | View source |
Not provided
There is not a plan to make IPD available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | proportion of doses | Randomization to 6 Months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Vascular disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly Muir | Durham VA Medical Center, Durham, NC | 919-286-0411 | 174035 | Kelly.Muir@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2018 | May 15, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dose monitoring and reminder | Behavioral | 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. |
|
|
| Educational - general | Behavioral | The control information session will include review of a Powerpoint presentation on general eye health, including but not specific to glaucoma. |
|
| Dose monitoring | Behavioral | 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. |
|
|
| 6 months |
| 12 Months |
| Total Cost at 6 Months | 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. | 6 months |
| VA Healthcare Workflow Effectiveness | 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. | 12 months |
| Cost-effectiveness Compared to Usual Care for Cost Per Blindness Averted | Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted | 12 months |
| Within-Trial Cost-Effectiveness of Adherence | 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) | 6 months |
| VA Workflow Effectiveness | The investigators will investigate the overall workload impacts to the VA healthcare system. | 12 months |
| 33892170 | Result | 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. |
| 36002073 | Result | 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. |
| 36603568 | Result | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Doses Per Day of Monitored Medication | Participants will be randomized at the first informational session in a 1:1 allocation to the intervention or to the control arm. Randomization will be stratified according to if a companion is or is not enrolled in the study with the participant and according to whether the glaucoma medication housed by the AdhereTech bottle is prescribed to be take once daily or more than once daily. | Count of Participants | Participants |
|
| Companion Status | Participants will be randomized at the first informational session in a 1:1 allocation to the intervention or to the control arm. Randomization will be stratified according to if a companion is or is not enrolled in the study with the participant and according to whether the glaucoma medication housed by the AdhereTech bottle is prescribed to be take once daily or more than once daily. | Count of Participants | Participants |
|
| OG000 | 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. |
| OG001 | 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. |
|
|
|
| Secondary | VA Medical Resource Use and Costs | 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. | 100 Intervention 100 Control | Posted | Mean | Standard Deviation | USD | 6 months |
|
|
|
| Other Pre-specified | Number of Participants With Newly Prescribed Glaucoma Therapy | 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 . | 200 randomized Veterans who are patients of the Durham VA Eye Clinic with medically-treated glaucoma. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Other Pre-specified | Total Cost at 6 Months | 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. | 100 Intervention (hypothetical cohort) 100 Control (hypothetical cohort) | Posted | Number | USD | 6 months |
|
|
|
| Other Pre-specified | VA Healthcare Workflow Effectiveness | 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. | 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. | Posted | 12 months |
|
|
| Other Pre-specified | Cost-effectiveness Compared to Usual Care for Cost Per Blindness Averted | Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted | 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. | Posted | 12 months |
|
|
| Other Pre-specified | Within-Trial Cost-Effectiveness of Adherence | 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) | Posted | Number | USD | 6 months |
|
|
|
| Other Pre-specified | VA Workflow Effectiveness | The investigators will investigate the overall workload impacts to the VA healthcare system. | 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. | Posted | 12 months |
|
|
| 4 |
| 100 |
| 3 |
| 100 |
| 1 |
| 100 |
| EG001 | 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. | 2 | 100 | 2 | 100 | 0 | 100 |
Not provided
Not provided
Not provided