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Interactive Study to Increase Glaucoma Adherence to Treatment (I-SIGHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Glanz, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00794170
First received: November 17, 2008
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Glaucoma
Behavioral: Telephone and Print based intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 312
Study Start Date: August 2008
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone and print based intervention
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
Thiss intervention consisted of tailored phone calls and follow-up mailings.
No Intervention: Usual care
The control group received usual care at each clinical site and interacted with study personnel only for data collection.

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794170

Locations
United States, Georgia
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30033
Grady Health System
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Karen Glanz, PhD, MPH Emory University
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Glanz, MD, Adjunct Professor of Public Health, Emory University
ClinicalTrials.gov Identifier: NCT00794170     History of Changes
Other Study ID Numbers: IRB00001335, R01 EY016997, I-SIGHT
Study First Received: November 17, 2008
Results First Received: August 15, 2012
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Treatment Compliance

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 20, 2014