Interactive Study to Increase Glaucoma Adherence to Treatment

Study Overview
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Brief Summary
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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
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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

Official Title
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I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation

Conditions
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Glaucoma

Intervention / Treatment
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* Behavioral: Telephone and Print based intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone and print based intervention<br>The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials. | Behavioral: Telephone and Print based intervention<br>* Thiss intervention consisted of tailored phone calls and follow-up mailings.<br>|
| No Intervention: Usual care<br>The control group received usual care at each clinical site and interacted with study personnel only for data collection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Compliance