Interactive Study to Increase Glaucoma Adherence to Treatment

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.

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Key information

Conditions

Glaucoma Behavior Eye Diseases Health Behavior Ocular Hypertension Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta VA Medical Center, Atlanta, Georgia, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telephone and Print based intervention

Behavioral

Thiss intervention consisted of tailored phone calls and follow-up mailings.

Primary outcomes

Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: I-SIGHT

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Nov 19, 2008
Registry last updated: Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed