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

Sponsor
Robin, Alan L., M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT00694876
Collaborator
(none)
250
1
28
8.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India
    Study Start Date :
    Jun 1, 2008
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Oct 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Adequate Health Literacy (as determined by TOFHLA)

    2

    Inadequate Health Literacy (as determined by TOFHLA)

    Outcome Measures

    Primary Outcome Measures

    1. Association between TOFHLA and REALM and the probability of return for follow-up visit [1 year from enrollemnt]

    Secondary Outcome Measures

    1. Association between religion, caste, education, socio-economic status, employment, and available time for doctor visits and the probability of return for follow-up visit. [1 year from enrollment]

    2. 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. [1 year from enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aravind Eye Hospital Madurai Tamil Nadu India 625 020

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Robin, Alan L., M.D.
    ClinicalTrials.gov Identifier:
    NCT00694876
    Other Study ID Numbers:
    • Health Literacy
    First Posted:
    Jun 11, 2008
    Last Update Posted:
    Nov 30, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Robin, Alan L., M.D.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2012