Primary Open Angle GlaucomaNCT01409421
RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence
A study testing motivational interviewing and three phone calls to remind patients to take their eye drops in people with Primary Open Angle Glaucoma, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The investigators are studying motivational interviewing (MI). MI is a counseling method to help people adopt healthy behaviors. The investigators will test whether MI improves patients' accurate use of glaucoma eye drops. The investigators will train eye clinic staff called glaucoma educators to use MI. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- motivational interviewing and three phone calls to remind patients to take their eye drops
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Jan 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- community-dwelling adults with primary or secondary open-angle glaucoma, and
- a current prescription for monotherapy topical glaucoma medication.
Who cannot join
- patient-reported inability to administer eye drops that cannot be addressed successfully through in-person instruction at the clinic,
- cognitive impairment at a level that would in the judgment of the referring physician interfere with study participation,
- referring physician's determination that glaucoma surgery is likely within the next 6 months,
- any active medical, psychological, or substance use disorder that would in the referring physician's judgment significantly interfere with study participation (e.g., comorbid congestive heart failure (CHF) resulting in a recent hospitalization; active psychosis due to uncontrolled bipolar disorder; etc.), or
- no visual field test within the past 6 months (data required for the randomization approach described below).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lions Eye Institute, UC Denver
Aurora, Colorado, 80045
Devers Eye Institute
Portland, Oregon, 97210
About this study
Official title: An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence
The investigators are studying motivational interviewing (MI). MI is a counseling method to help people adopt healthy behaviors. The investigators will test whether MI improves patients' accurate use of glaucoma eye drops. The investigators will train eye clinic staff called glaucoma educators to use MI. Up to 250 patients at 3 clinics will be recruited. All patients will receive their usual eye care. Based on chance, some patients will also be supported by a glaucoma educator. The groups will be compared on medication adherence using micro-electro-mechanical system(MEMS). MEMS are electronic bottle caps that track when a medication bottle is opened. Patients will be aware that their medication use is tracked. The groups will also be compared on treatment value, outcomes, and cost. The investigators will also collect data on variables that may predict medication adherence.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- motivational interviewing, three phone calls to remind patients to take their eye drops
- Keywords
- adherence, glaucoma, motivational interviewing
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingBehavioural
counseling intervention
three phone calls to remind patients to take their eye dropsBehavioural
reminder phone calls
| Study group | Role | What they receive |
|---|---|---|
| motivational interviewing | Experimental | 3 phone and 3 in person counseling support sessions with glaucoma educator Receives: Behavioral: motivational interviewing |
| reminder calls | Active comparator | behavioral: three phone calls to remind patients to take their eye drops Receives: Behavioral: three phone calls to remind patients to take their eye drops |
| standard care | No intervention | standard care for glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcomes - MEMS-based Medication Adherence and Persistence:
Compare adherence and persistence between the intervention and control groups. (Medication Event Monitoring Systems)that record the date and time a pill bottle is opened we are evaluating the percentage of prescribed doses taken during ain one-week intervals, but will augment it by also considering a more fine-grained percentage of prescribed doses taken in required dosing window (defined as within 3 hours before or after the scheduled time) as a second primary outcome measure.
Measured: 1 month
Secondary outcomes (1)
Counselor-Rated Medication Adherence
we will supplement MEMS-based adherence metrics with a counselor rating of adherence completed by the glaucoma educator during each in-person or telephone contact with intervention group participants. The interview also measures patients' perceived reasons for nonadherence, including treatment cost, lack of commitment based on low perceived benefits of treatment, and fear of potential adverse drug events (ADEs)
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Malik Kahook, MD, Principal investigator, Lions Eye Inst. UC DenverPaul F Cook, Ph.D, Principal investigator, UC Denver, College of NursingJeffery Kammer, MD, Principal investigator, Vanderbilt University- OpthamologySteve Mansberger, MD, Principal investigator, Devers Eye Inst. Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409421
- Sponsor's protocol ID
- 11-0122
- Other IDs
- 2517807
- Status last verified
- Sep 2015
- First submitted
- 2 Aug 2011
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cook PF, Schmiege SJ, Mansberger SL, Kammer J, Fitzgerald T, Kahook MY. Predictors of adherence to glaucoma treatment in a multisite study. Ann Behav Med. 2015 Feb;49(1):29-39. doi: 10.1007/s12160-014-9641-8.
PubMed 25248302
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence
- ClinicalTrials.gov ID
- NCT01409421
- Acronym / sponsor ID
- 11-0122
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- adherence, glaucoma, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Aug 2011 (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 investigators are studying motivational interviewing (MI). MI is a counseling method to help people adopt healthy behaviors. The investigators will test whether MI improves patients' accurate use of glaucoma eye drops. The investigators will train eye clinic staff called glaucoma educators to use MI. Up to 250 patients at 3 clinics will be recruited. All patients will receive their usual eye care. Based on chance, some patients will also be supported by a glaucoma educator. The groups will be compared on medication adherence using micro-electro-mechanical system(MEMS). MEMS are electronic bottle caps that track when a medication bottle is opened. Patients will be aware that their medication use is tracked. The groups will also be compared on treatment value, outcomes, and cost. The investigators will also collect data on variables that may predict medication adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| motivational interviewing | Experimental | Behavioral: motivational interviewing3 phone and 3 in person counseling support sessions with glaucoma educator |
| reminder calls | Active comparator | Behavioral: three phone calls to remind patients to take their eye dropsbehavioral: three phone calls to remind patients to take their eye drops |
| standard care | No intervention | –standard care for glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- community-dwelling adults with primary or secondary open-angle glaucoma, and
- a current prescription for monotherapy topical glaucoma medication.
Key exclusion criteria (5 listed)
- patient-reported inability to administer eye drops that cannot be addressed successfully through in-person instruction at the clinic,
- cognitive impairment at a level that would in the judgment of the referring physician interfere with study participation,
- referring physician's determination that glaucoma surgery is likely within the next 6 months,
- any active medical, psychological, or substance use disorder that would in the referring physician's judgment significantly interfere with study participation (e.g., comorbid congestive heart failure (CHF) resulting in a recent hospitalization; active psychosis due to uncontrolled bipolar disorder; etc.), or
- no visual field test within the past 6 months (data required for the randomization approach described below).
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 |
|---|---|---|
| motivational interviewingcounseling intervention | Behavioural | motivational interviewing |
| three phone calls to remind patients to take their eye dropsreminder phone calls | Behavioural | reminder calls |
Primary outcome
Primary Outcomes - MEMS-based Medication Adherence and Persistence:
Time frame: 1 month
Compare adherence and persistence between the intervention and control groups. (Medication Event Monitoring Systems)that record the date and time a pill bottle is opened we are evaluating the percentage of prescribed doses taken during ain one-week intervals, but will augment it by also considering a more fine-grained percentage of prescribed doses taken in required dosing window (defined as within 3 hours before or after the scheduled time) as a second primary outcome measure.
1 secondary outcome
Counselor-Rated Medication Adherence
Time frame: 1 Month
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 1 Oct 2015.
- Derived from this study: PubMed 25248302Cook PF, Schmiege SJ, Mansberger SL, Kammer J, Fitzgerald T, Kahook MY. Predictors of adherence to glaucoma treatment in a multisite study. Ann Behav Med. 2015 Feb;49(1):29-39. doi: 10.1007/s12160-014-9641-8.
Related trials for Primary Open Angle Glaucoma
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Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
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The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
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Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
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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 Kahook, MD principal investigator
Lions Eye Inst. UC Denver
Paul F Cook, Ph.D principal investigator
UC Denver, College of Nursing
Jeffery Kammer, MD principal investigator
Vanderbilt University- Opthamology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing and three phone calls to remind patients to take their eye drops in people with Primary Open Angle Glaucoma, run by University of Colorado, Denver at 2 sites 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 2 inclusion and 5 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 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Outcomes - MEMS-based Medication Adherence and Persistence: (time frame: 1 month). 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 NCT01409421, which also lists 1 linked publication.
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 1 Oct 2015.