GlaucomaNCT00454922
Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
A study testing education in people with Glaucoma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication, which may result in loss of vision, is known to be prevalent. Available information regarding adherence to prescribed medical therapy suggests that some apparent treatment failures may actually be due to non-adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary or secondary open angle glaucoma.
- Currently on monotherapy drop treatment for glaucoma.
- Age > 18 years.
- Patient has presented for care at the Rocky Mountain Lions Eye Institute Glaucoma Center.
Who cannot join
- Inability to independently administer eye drops due to physical disability as reported by the patient.
- Cognitive impairment that would interfere with the ability to self-administer medications as evidenced by a TICS score < 16.
- Patients who demonstrate > 80% adherence to glaucoma treatment during the 30 day run-in period.
- It is anticipated that the patient will require glaucoma surgery within the next six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045
About this study
Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication, which may result in loss of vision, is known to be prevalent. Available information regarding adherence to prescribed medical therapy suggests that some apparent treatment failures may actually be due to non-adherence. The investigators' specific aim is to conduct a study that will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma therapy. The investigators' hypothesis is that patient education and counseling delivered by a trained glaucoma educator, through both planned visits and telephone contacts, will increase adherence to topical glaucoma therapy.
- Conditions
- Glaucoma
- Being tested
- standard of care, education
- Keywords
- glaucoma, patient educator
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careBehavioural
no intervention
educationOther
meet with trained glaucoma educator 6 times over life of study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | education Receives: Other: education |
| 2 | Placebo comparator | standard of care Receives: Behavioral: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome is adherence.
Measured: 6 months
Secondary outcomes (2)
differences between patients randomized to standard of care and education intervention.
Measured: 6 months
differences between dropouts and non-dropouts.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2012
- Study completionJan 2012
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Y. Kahook, MD, Principal investigator, Rocky Mountain Lions Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454922
- Sponsor's protocol ID
- 07-0106
- Status last verified
- Oct 2008
- First submitted
- 29 Mar 2007
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00454922
- Acronym / sponsor ID
- 07-0106
- Conditions
- Glaucoma
- Keywords
- glaucoma, patient educator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Apr 2007 (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.
Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication, which may result in loss of vision, is known to be prevalent. Available information regarding adherence to prescribed medical therapy suggests that some apparent treatment failures may actually be due to non-adherence. The investigators' specific aim is to conduct a study that will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma therapy. The investigators' hypothesis is that patient education and counseling delivered by a trained glaucoma educator, through both planned visits and telephone contacts, will increase adherence to topical glaucoma therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: educationeducation |
| 2 | Placebo comparator | Behavioral: standard of carestandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of primary or secondary open angle glaucoma.
- Currently on monotherapy drop treatment for glaucoma.
- Age > 18 years.
- Patient has presented for care at the Rocky Mountain Lions Eye Institute Glaucoma Center.
Key exclusion criteria (4 listed)
- Inability to independently administer eye drops due to physical disability as reported by the patient.
- Cognitive impairment that would interfere with the ability to self-administer medications as evidenced by a TICS score < 16.
- Patients who demonstrate > 80% adherence to glaucoma treatment during the 30 day run-in period.
- It is anticipated that the patient will require glaucoma surgery within the next six months.
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 |
|---|---|---|
| standard of careno intervention | Behavioural | 2 |
| educationmeet with trained glaucoma educator 6 times over life of study | Other | 1 |
Primary outcome
primary outcome is adherence.
Time frame: 6 months
2 secondary outcomes
differences between patients randomized to standard of care and education intervention.
Time frame: 6 months
differences between dropouts and non-dropouts.
Time frame: 6 months
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 6 Dec 2012.
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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.
Malik Y. Kahook, MD principal investigator
Rocky Mountain Lions Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Glaucoma, run by University of Colorado, Denver 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 4 inclusion and 4 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 6 Dec 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 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. Some participants in this study may receive a placebo. 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?
primary outcome is adherence. (time frame: 6 months). 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 6 Dec 2012.