Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India

November 29, 2012 updated by: Robin, Alan L., M.D.
The purpose of this study is to determine how health literacy impacts glaucoma patient adherence (as measured by following up with the doctor) in Tamil Nadu, India. We hypothesize that individuals with better health literacy will have higher rates of follow-up with their ophthalmologist.

Study Overview

Status

Completed

Conditions

Detailed Description

Many studies have shown the importance of health literacy on patient adherence in the United States (Juzych, M, et al., 2008; Muir, KW, et al., 2006). Low adherence in glaucoma patients leads to increased intraocular pressure, optic nerve damage, and blindness. To date, no research has been done with health literacy and patient adherence in the developing world.

We will use TOFHLA and REALM to assess the health literacy of glaucoma patients in Tamil Nadu, India. We will also survey other demographic information and patient knowledge of glaucoma. This information will be compared with follow-up rates to identify barriers to patient adherence.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625 020
        • Aravind Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Glaucoma Patients from Aravind Eye Hospital at Madurai, Tamil Nadu, India

Description

Inclusion Criteria:

  • Better than 20/100 corrected vision in better eye
  • Must live within 50 miles of Aravind Eye Hospital
  • Clinical diagnosis of primary glaucoma
  • Paying patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Adequate Health Literacy (as determined by TOFHLA)
2
Inadequate Health Literacy (as determined by TOFHLA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association between TOFHLA and REALM and the probability of return for follow-up visit
Time Frame: 1 year from enrollemnt
1 year from enrollemnt

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between religion, caste, education, socio-economic status, employment, and available time for doctor visits and the probability of return for follow-up visit.
Time Frame: 1 year from enrollment
1 year from enrollment
Association between marital status, number of dependents, family history of glaucoma, travel, need for an escort, understanding of glaucoma, and paying status and the probability of return for follow-up visit.
Time Frame: 1 year from enrollment
1 year from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robin, Alan L., M.D.

Investigators

  • Principal Investigator: Benjamin R Curran, BS, Loyola University Chicago, Stritch School of Medicine
  • Study Director: Alan L Robin, MD, University of Maryland; Johns Hopkins University, Wilmer Institute and Bloomberg School of Public Health
  • Study Director: Ramaswami Krishnadas, DO, DNB, Aravind Eye Hospital, CMO
  • Study Director: Scott D Smith, MD, MPH, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 7, 2008

First Submitted That Met QC Criteria

June 7, 2008

First Posted (Estimate)

June 11, 2008

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Health Literacy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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