GlaucomaPhase 4NCT00376974
The Effect of Education on Patient Compliance
A Phase 4 study testing American Academy of Ophthalmology Glaucoma Educational Tape in people with Glaucoma, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
Trial summary
With patient education, the compliance with glaucoma medications will increase. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Glaucoma
- What is being tested?
- American Academy of Ophthalmology Glaucoma Educational Tape
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2006
- Phase
- Phase 4
- 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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glaucoma patients coming in for routine examination
Who cannot join
- If glaucoma was unstable and treatment regimen required a change
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Patient Education on Glaucoma Medication Compliance
With patient education, the compliance with glaucoma medications will increase.
Read the detailed description
We divided glaucoma patients into two groups; one watched a video the others did not. We checked their intraocular pressures before and after the intervention to see if there was a difference
- Conditions
- Glaucoma
- Being tested
- American Academy of Ophthalmology Glaucoma Educational Tape
- Keywords
- glaucoma, compliance, intraocular pressure, video
- Medical subject headings
- Glaucoma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Academy of Ophthalmology Glaucoma Educational TapeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Secondary outcomes (1)
Score on glaucoma educational test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startMar 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Investigators
- Silvia Orengo-Nania, m.d., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376974
- Sponsor's protocol ID
- 2006-1
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2006
- Last updated
- 15 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Education on Glaucoma Medication Compliance
- ClinicalTrials.gov ID
- NCT00376974
- Acronym / sponsor ID
- 2006-1
- Conditions
- Glaucoma
- Keywords
- glaucoma, compliance, intraocular pressure, video
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- Mar 2005
- Study completion
- May 2006
- First posted
- 15 Sep 2006 (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.
With patient education, the compliance with glaucoma medications will increase.
Detailed description
We divided glaucoma patients into two groups; one watched a video the others did not. We checked their intraocular pressures before and after the intervention to see if there was a difference
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Glaucoma patients coming in for routine examination
Key exclusion criteria (1 listed)
- If glaucoma was unstable and treatment regimen required a change
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| American Academy of Ophthalmology Glaucoma Educational Tape | Behavioural | – |
Primary outcome
Intraocular pressure
1 secondary outcome
Score on glaucoma educational test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2006.
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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.
Silvia Orengo-Nania, m.d. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing American Academy of Ophthalmology Glaucoma Educational Tape in people with Glaucoma, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 2006. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Intraocular pressure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2006.