Patient NoncomplianceNCT00694876
Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India
An observational study of Patient Noncompliance and Health Literacy, run by Robin, Alan L., M.D. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Patient Noncompliance, Health Literacy, Glaucoma
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2008to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma Patients from Aravind Eye Hospital at Madurai, Tamil Nadu, India
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Patient Noncompliance, Health Literacy, Glaucoma
- Keywords
- Health Literacy, Patient Nonadherence, Patient Noncompliance, Follow Up, India, Glaucoma
- Medical subject headings
- Patient Compliance, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adequate Health Literacy (as determined by TOFHLA) | |
| 2 | Inadequate Health Literacy (as determined by TOFHLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between TOFHLA and REALM and the probability of return for follow-up visit
Measured: 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.
Measured: 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.
Measured: 1 year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient NoncomplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robin, Alan L., M.D.
- Responsible party
- Sponsor
- Investigators
- Benjamin R Curran, BS, Principal investigator, Loyola University Chicago, Stritch School of MedicineAlan L Robin, MD, Study director, University of Maryland; Johns Hopkins University, Wilmer Institute and Bloomberg School of Public HealthRamaswami Krishnadas, DO, DNB, Study director, Aravind Eye Hospital, CMOScott D Smith, MD, MPH, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694876
- Sponsor's protocol ID
- Health Literacy
- Status last verified
- Nov 2012
- First submitted
- 7 Jun 2008
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18474786Muir 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.
PubMed 16876500Friedman 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.
PubMed 18321582
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India
- ClinicalTrials.gov ID
- NCT00694876
- Acronym / sponsor ID
- Health Literacy
- Conditions
- Patient Noncompliance, Health Literacy, Glaucoma
- Keywords
- Health Literacy, Patient Nonadherence, Patient Noncompliance, Follow Up, India, Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Robin, Alan L., M.D.
- Study start
- Jun 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adequate Health Literacy (as determined by TOFHLA) |
| 2 | – | –Inadequate Health Literacy (as determined by TOFHLA) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma Patients from Aravind Eye Hospital at Madurai, Tamil Nadu, India
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between TOFHLA and REALM and the probability of return for follow-up visit
Time frame: 1 year from enrollemnt
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Background: PubMed 18474786Juzych 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.
- Background: PubMed 16876500Muir 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.
- Background: PubMed 18321582Friedman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin R Curran, BS principal investigator
Loyola University Chicago, Stritch School of Medicine
Alan L Robin, MD study director
University of Maryland; Johns Hopkins University, Wilmer Institute and Bloomberg School of Public Health
Ramaswami Krishnadas, DO, DNB study director
Aravind Eye Hospital, CMO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Noncompliance and Health Literacy, run by Robin, Alan L., M.D. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between TOFHLA and REALM and the probability of return for follow-up visit (time frame: 1 year from enrollemnt). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.