Glaucoma
Conditions
Keywords
Ophthalmology, Glaucoma, Medication Adherence, Motivational Interviewing, Tailored Education, Self Management
Brief summary
This study will test whether the Support, Educate, Empower (SEE) personalized Glaucoma Coaching Program improves eye drop medication adherence among glaucoma patients compared to enhanced standard care in a randomized controlled clinical trial. As a secondary outcome, the study will test whether glaucoma related distress decreases among SEE program participants compared to the control group. The study hypothesis is that glaucoma patients with poor adherence who receive motivational-interviewing based counseling and personalized education from a trained non-physician glaucoma coach through the SEE Program will improve their medication adherence compared to glaucoma patients standard care enhanced by additional educational handouts.
Interventions
BEHAVIORALPersonalized Glaucoma Coaching
This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
BEHAVIORALEnhanced Standard care
Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
Sponsors
National Eye Institute (NEI)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Taking greater or equal to 1 ocular hypotensive medication with a diagnosis of any kind of glaucoma, suspected glaucoma or ocular hypertension * Did not opt-out from recruitment letter
Exclusion criteria
* Do not speak English * Have a diagnosed serious mental illness (for example, Schizophrenia) * Diagnosed cognitive impairment * Do not instill their own eye drops * Had laser or incisional glaucoma surgery within three months of enrollment or scheduled during the six-month study period * Unable to attend all study visits * Active ocular infection or uveitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Electronically Monitored Medication Adherence Over Six Months | Up to 6 months | Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the percentage of doses taken on time divided by total doses prescribed over the six-month study period. The calculation censored participants at the time of withdrawal, loss to follow-up, or disengagement (attended the exit visit but may have gone some time before this visit without adherence monitor activity) and their adherence was calculated only during the reduced time on study. Additionally, times noted where monitors malfunctioned or went unused due to vacation or hospitalization were excluded. |
| Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period | Up to 6 months | Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the percentage of doses taken on time divided by total doses prescribed over the six-month study period. The calculation censored participants at the time of withdrawal, loss to follow-up, or disengagement (attended the exit visit but may have gone some time before this visit without adherence monitor activity) and their adherence was calculated only during the reduced time on study. Additionally, times noted where monitors malfunctioned or went unused due to vacation or hospitalization were excluded. Continuous percentage adherence was dichotomized to a binary outcome as \>= 80% vs \< 80% medication adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glaucoma-related Distress | 6 months | Glaucoma-related Distress will be measured by the Diabetes Distress Scale adapted for glaucoma, a 17-item scale where each item is assessed on a 6-point Likert scale. A composite score is calculated as a mean of the 17 items, ranging from 1 to 6, where a higher score indicates a higher distress level. Mean change in Glaucoma-related Distress will be compared between the intervention and control groups. Six-month change from baseline is calculated by subtracting the baseline value from the six-month score. Negative number for change indicates that participant distress decreased over time and a positive number for change would indicate that distress increased. |
Countries
United States
Participant flow
Pre-assignment details
236 participants were consented. 235 were randomized. The unrandomized individual was determined to be ineligible post-consenting.
Participants by arm
| Arm | Count |
|---|---|
| SEE Intervention - Personalized Glaucoma Coaching SEE Intervention - Personalized Glaucoma Coaching: This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder. | 117 |
| Enhanced Care Control Enhanced Care Control: Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period. | 118 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 17 | 7 |
| Overall Study | Removed due to determination of participant noncompliance | 2 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | SEE Intervention - Personalized Glaucoma Coaching | Enhanced Care Control | Total |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 11.5 | 68.2 years STANDARD_DEVIATION 10.4 | 67.3 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 101 Participants | 202 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 13 Participants | 27 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Black | 68 Participants | 71 Participants | 139 Participants |
| Race/Ethnicity, Customized Not Reported | 6 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 36 Participants | 68 Participants |
| Region of Enrollment United States | 117 Participants | 118 Participants | 235 Participants |
| Sex/Gender, Customized Female | 64 Participants | 60 Participants | 124 Participants |
| Sex/Gender, Customized Male | 53 Participants | 57 Participants | 110 Participants |
| Sex/Gender, Customized Not Reported | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 117 | 2 / 118 |
| other Total, other adverse events | 18 / 117 | 7 / 118 |
| serious Total, serious adverse events | 0 / 117 | 0 / 118 |
Outcome results
Primary
Mean Percent Electronically Monitored Medication Adherence Over Six Months
Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the percentage of doses taken on time divided by total doses prescribed over the six-month study period. The calculation censored participants at the time of withdrawal, loss to follow-up, or disengagement (attended the exit visit but may have gone some time before this visit without adherence monitor activity) and their adherence was calculated only during the reduced time on study. Additionally, times noted where monitors malfunctioned or went unused due to vacation or hospitalization were excluded.
Time frame: Up to 6 months
Population: Data is shown for participants who provided data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SEE Intervention - Personalized Glaucoma Coaching | Mean Percent Electronically Monitored Medication Adherence Over Six Months | 77.6 percent adherence | Standard Deviation 19.7 |
| Enhanced Care Control | Mean Percent Electronically Monitored Medication Adherence Over Six Months | 58.0 percent adherence | Standard Deviation 25.2 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period
Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the percentage of doses taken on time divided by total doses prescribed over the six-month study period. The calculation censored participants at the time of withdrawal, loss to follow-up, or disengagement (attended the exit visit but may have gone some time before this visit without adherence monitor activity) and their adherence was calculated only during the reduced time on study. Additionally, times noted where monitors malfunctioned or went unused due to vacation or hospitalization were excluded. Continuous percentage adherence was dichotomized to a binary outcome as \>= 80% vs \< 80% medication adherence.
Time frame: Up to 6 months
Population: Data is shown for participants who provided data for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SEE Intervention - Personalized Glaucoma Coaching | Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period | Adherence >= 80% | 62 Participants |
| SEE Intervention - Personalized Glaucoma Coaching | Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period | Adherence < 80% | 51 Participants |
| Enhanced Care Control | Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period | Adherence >= 80% | 27 Participants |
| Enhanced Care Control | Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period | Adherence < 80% | 87 Participants |
p-value: <0.001Chi-squared
Secondary
Change in Glaucoma-related Distress
Glaucoma-related Distress will be measured by the Diabetes Distress Scale adapted for glaucoma, a 17-item scale where each item is assessed on a 6-point Likert scale. A composite score is calculated as a mean of the 17 items, ranging from 1 to 6, where a higher score indicates a higher distress level. Mean change in Glaucoma-related Distress will be compared between the intervention and control groups. Six-month change from baseline is calculated by subtracting the baseline value from the six-month score. Negative number for change indicates that participant distress decreased over time and a positive number for change would indicate that distress increased.
Time frame: 6 months
Population: Data is reported for people who came to the exit visit and provided both baseline and 6-month data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SEE Intervention - Personalized Glaucoma Coaching | Change in Glaucoma-related Distress | Baseline | 2.5 score on a scale | Standard Deviation 0.9 |
| SEE Intervention - Personalized Glaucoma Coaching | Change in Glaucoma-related Distress | 6 months | 1.9 score on a scale | Standard Deviation 0.8 |
| SEE Intervention - Personalized Glaucoma Coaching | Change in Glaucoma-related Distress | 6 month change from Baseline | -0.6 score on a scale | Standard Deviation 0.9 |
| Enhanced Care Control | Change in Glaucoma-related Distress | Baseline | 2.4 score on a scale | Standard Deviation 0.8 |
| Enhanced Care Control | Change in Glaucoma-related Distress | 6 months | 2.2 score on a scale | Standard Deviation 0.9 |
| Enhanced Care Control | Change in Glaucoma-related Distress | 6 month change from Baseline | -0.2 score on a scale | Standard Deviation 0.7 |
95% CI: [-0.5, -0.1]