Interactive Study to Increase Glaucoma Adherence to Treatment

NCT00794170 | Completed Results

• 3 other identifiers: IRB00001335R01EY016997I-SIGHT
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma

Keywords

Treatment Compliance

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 12 months

Study Arms (2)

Telephone and print based intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

Telephone and Print based intervention BEHAVIORAL

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

Telephone and print based intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having eye surgery within 3 months of baseline interview and enrollment
• Being legally blind (20/200 or worse)

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

• 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.

  PMID: 22688429 DERIVED

MeSH Terms

Conditions

Glaucoma; Patient Compliance

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

There may have been a selection bias that contributed to a placebo effect in the control group. The "control" patients may have already been motivated to seek knowledge or involvement in management of glaucoma.

Results Point of Contact

• Title: Karen Glanz
• Organization: University of Pennsylvania

kglanz@upenn.edu

215-898-0613

Study Officials

• Karen Glanz, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor of Public Health

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

US (2)