NCT00694876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

2.3 years

First QC Date

June 7, 2008

Last Update Submit

November 29, 2012

Conditions

Keywords

Health LiteracyPatient NonadherencePatient NoncomplianceFollow UpIndiaGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Association between TOFHLA and REALM and the probability of return for follow-up visit

    1 year from enrollemnt

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

1

Adequate Health Literacy (as determined by TOFHLA)

2

Inadequate Health Literacy (as determined by TOFHLA)

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

Location

Related Publications (3)

  • 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.

    PMID: 18474786BACKGROUND
  • 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.

    PMID: 16876500BACKGROUND
  • 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.

    PMID: 18321582BACKGROUND

MeSH Terms

Conditions

Patient ComplianceGlaucoma

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorOcular HypertensionEye Diseases

Study Officials

  • Benjamin R Curran, BS

    Loyola University Chicago, Stritch School of Medicine

    PRINCIPAL INVESTIGATOR
  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2008

First Posted

June 11, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations