MedPath

Interactive Study to Increase Glaucoma Adherence to Treatment

Not Applicable
Completed
Conditions
Glaucoma
Registration Number
NCT00794170
Lead Sponsor
Emory University
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
312
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Atlanta VA Medical Center

🇺🇸

Atlanta, Georgia, United States

Grady Health System

🇺🇸

Atlanta, Georgia, United States

Atlanta VA Medical Center
🇺🇸Atlanta, Georgia, United States

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