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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Emory University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00794170
First received: November 17, 2008
Last updated: May 25, 2010
Last verified: May 2010
History of Changes
  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-based

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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Administrative data on prescription drug renewals, appointment compliance and medication taking (e.g. physician notes) [ Time Frame: Baseline, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-report data on compliance knowledge, attitudes, and behaviors [ Time Frame: Baseline, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 312
Study Start Date: August 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Telephone-based
    The intervention will be 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 will utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients.
Detailed Description:

The intervention will be 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 will utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients. We will evaluate 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
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, PhD, MPH, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00794170     History of Changes
Other Study ID Numbers: I-SIGHT, R01 EY016997
Study First Received: November 17, 2008
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Treatment Compliance

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013