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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robin, Alan L., M.D.
ClinicalTrials.gov Identifier:
NCT00694876
First received: June 7, 2008
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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
Patient Noncompliance
Health Literacy
Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India

Resource links provided by NLM:


Further study details as provided by Robin, Alan L., M.D.:

Primary Outcome Measures:
  • Association between TOFHLA and REALM and the probability of return for follow-up visit [ Time Frame: 1 year from enrollemnt ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: June 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adequate Health Literacy (as determined by TOFHLA)
2
Inadequate Health Literacy (as determined by TOFHLA)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694876

Locations
India
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
  More Information

Publications:
Responsible Party: Robin, Alan L., M.D.
ClinicalTrials.gov Identifier: NCT00694876     History of Changes
Other Study ID Numbers: Health Literacy
Study First Received: June 7, 2008
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Keywords provided by Robin, Alan L., M.D.:
Health Literacy
Patient Nonadherence
Patient Noncompliance
Follow Up
India
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014