Interactive Study to Increase Glaucoma Adherence to Treatment - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00794170

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 18-month follow-up than participants who receive the control group intervention.

Condition	Intervention
Glaucoma	Behavioral: Telephone-based

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

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

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, 12 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self-report data on compliance knowledge, attitudes, and behaviors [ Time Frame: Baseline, 6, 12 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	August 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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 every six months for 18 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

Contacts

Contact: Karen Glanz, PhD, MPH	404-727-7536	kglanz@sph.emory.edu
Contact: Lucja T Bundy, MA, EdM	404-727-5527	lbundy@sph.emory.edu

Locations

United States, Georgia
Atlanta VA Medical Center	Recruiting
Atlanta, Georgia, United States, 30033
Contact: Katharina Echt, PhD 404-321-6111 ext 1-6323 kecht@emory.edu
Contact: Lucja T Bundy, MA, EdM 404-727-5527 lbundy@sph.emory.edu
Sub-Investigator: Katharina Echt, PhD
Grady Health System	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Susan Primo, OD, MPH 404-778-3317 Susan.Primo@emoryhealthcare.org
Contact: Lucja T Bundy, MA, EdM 404-727-5527 lbundy@sph.emory.edu
Sub-Investigator: Susan Primo, OD, MPH

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Karen Glanz, PhD, MPH

Emory University

More Information

Responsible Party:	Emory University ( Karen Glanz, PhD, MPH )
Study ID Numbers:	I-SIGHT, R01 EY016997
Study First Received:	November 17, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00794170
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Treatment Compliance

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 14, 2009