Interactive Study to Increase Glaucoma Adherence to Treatment

NCT ID: NCT00794170

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-09-30

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

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telephone and Print based intervention

Intervention Type: BEHAVIORAL

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

Usual care

The control group received usual care at each clinical site and interacted with study personnel only for data collection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telephone and Print based intervention

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

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Karen Glanz, MD

Adjunct Professor of Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Glanz, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Atlanta VA Medical Center

Atlanta, Georgia, United States

Grady Health System

Atlanta, Georgia, United States

Countries

United States

References

Glanz K, Beck AD, Bundy L, Primo S, Lynn MJ, Cleveland J, Wold JA, Echt KV. Impact of a health communication intervention to improve glaucoma treatment adherence. Results of the interactive study to increase glaucoma adherence to treatment trial. Arch Ophthalmol. 2012 Oct;130(10):1252-8. doi: 10.1001/archophthalmol.2012.1607.

Reference Type: DERIVED

PMID: 22688429 (View on PubMed)

Other Identifiers

R01EY016997

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I-SIGHT

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00001335

Identifier Type: -

Identifier Source: org_study_id