Clinical trial NCT00694876: Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India
Official title: Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Noncompliance
Health Literacy
Glaucoma
Keywords: Health Literacy
Patient Nonadherence
Patient Noncompliance
Follow Up
India
Glaucoma
Lead sponsor: Robin, Alan L., M.D.
Sponsor class: INDIV
First posted: 2008-06-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Glaucoma Patients from Aravind Eye Hospital at Madurai, Tamil Nadu, India

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.

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 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

Primary outcomes:
measure: Association between TOFHLA and REALM and the probability of return for follow-up visit
timeFrame: 1 year from enrollemnt
Secondary outcomes:
measure: Association between religion, caste, education, socio-economic status, employment, and available time for doctor visits and the probability of return for follow-up visit.
timeFrame: 1 year from enrollment
measure: 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.
timeFrame: 1 year from enrollment
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Loyola University Chicago, Stritch School of Medicine
name: Benjamin R Curran, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland; Johns Hopkins University, Wilmer Institute and Bloomberg School of Public Health
name: Alan L Robin, MD
role: STUDY_DIRECTOR
affiliation: Aravind Eye Hospital, CMO
name: Ramaswami Krishnadas, DO, DNB
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Scott D Smith, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Juzych MS, Randhawa S, Shukairy A, Kaushal P, Gupta A, Shalauta N. Functional health literacy in patients with glaucoma in urban settings. Arch Ophthalmol. 2008 May;126(5):718-24. doi: 10.1001/archopht.126.5.718.
citation: Muir KW, Santiago-Turla C, Stinnett SS, Herndon LW, Allingham RR, Challa P, Lee PP. Health literacy and adherence to glaucoma therapy. Am J Ophthalmol. 2006 Aug;142(2):223-6. doi: 10.1016/j.ajo.2006.03.018.
citation: Friedman DS, Hahn SR, Gelb L, Tan J, Shah SN, Kim EE, Zimmerman TJ, Quigley HA. Doctor-patient communication, health-related beliefs, and adherence in glaucoma results from the Glaucoma Adherence and Persistency Study. Ophthalmology. 2008 Aug;115(8):1320-7, 1327.e1-3. doi: 10.1016/j.ophtha.2007.11.023. Epub 2008 Mar 5.