Glaucoma
Conditions
Keywords
Treatment Compliance
Brief summary
Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention.
Detailed description
The intervention is telephone-based and individually-tailored to participants' compliance knowledge, attitudes, and behaviors; psychosocial predictors of compliance; health literacy; race and culture; and prescribed medication regimen. The intervention calls utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients. We evaluated the intervention in a randomized controlled trial with telephone interviews administered to all participants at baseline, 6, 9, and 12-months
Interventions
BEHAVIORALTelephone and Print based intervention
Thiss intervention consisted of tailored phone calls and follow-up mailings.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Receive treatment at the Atlanta VA Medical Center or Grady Eye clinic for their eye condition * Be between the ages of 18-80 * Be Caucasian or African American * Possess a telephone (home telephone or cellular phone) * Speak and understand English * Be diagnosed with open angle glaucoma, be glaucoma suspect, or be ocular hypertensive for at least one year * Be prescribed daily doses of topical treatments for at least one year * Be able to read or have someone who can help the participant with reading written materials that we give to the participant
Exclusion criteria
* Having eye surgery within 3 months of baseline interview and enrollment * Being legally blind (20/200 or worse)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) | Baseline and 12 months | The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telephone and Print Based Intervention This was a tailored phone call followed up by print materials. | 157 |
| Usual Care control | 155 |
| Total | 312 |
Baseline characteristics
| Characteristic | Telephone and Print Based Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 66 Participants | 60 Participants | 126 Participants |
| Age, Categorical Between 18 and 65 years | 91 Participants | 95 Participants | 186 Participants |
| Region of Enrollment United States | 157 participants | 155 participants | 312 participants |
| Sex: Female, Male Female | 59 Participants | 58 Participants | 117 Participants |
| Sex: Female, Male Male | 98 Participants | 97 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 157 | 0 / 155 |
| serious Total, serious adverse events | 0 / 157 | 0 / 155 |
Outcome results
Primary
Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)
The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.
Time frame: Baseline and 12 months
Population: The two treatment groups were compared on change in the percent of adherent patients between baseline and follow-up using a longitudinal logistic regression model fit using a generalized linear model. A p-value less than 0.05 was considered statistically significant. No statistical comparison was done.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telephone and Print Intervention | Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) | 150 participants |
| Usual Care | Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) | 152 participants |