Interactive Study to Increase Glaucoma Adherence to Treatment

Glaucoma Clinical Trial

— I-SIGHT  

Official title:

I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794170
• Other study ID #: IRB00001335
• Secondary ID: R01EY016997I-SIG
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: May 9, 2014
• Start date: August 2008
• Est. completion date: September 2010

Study information

• Verified date: May 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glaucoma

Intervention

Behavioral:
• Telephone and Print based intervention
Thiss intervention consisted of tailored phone calls and follow-up mailings.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No