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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694876
• Other study ID #: Health Literacy
• Status: Completed
• Phase: N/A
• First received: June 7, 2008
• Last updated: November 29, 2012
• Start date: June 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2012
• Source: Robin, Alan L., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Health Literacy
• Patient Noncompliance

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Robin, Alan L., M.D.

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between TOFHLA and REALM and the probability of return for follow-up visit		1 year from enrollemnt	No
Secondary	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	No
Secondary	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	No