GlaucomaNCT00672048
Partnership for Glaucoma
A study testing Computer Tablet, Continuing Education Course and Continuing education in people with Glaucoma, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to develop new ways of assisting patients with glaucoma and their eye doctors in using the recommendations from practice guidelines. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- What is being tested?
- Computer Tablet, Continuing Education Course and Continuing education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 721 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2007to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Diagnosis of open angle glaucoma with documented visual field loss.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama
Birmingham, Alabama, 35204
Duke University
Durham, North Carolina, 27705
About this study
Official title: Expanding Quality Care for Glaucoma Through a Provider-Patient Partnership
The purpose of this study is to develop new ways of assisting patients with glaucoma and their eye doctors in using the recommendations from practice guidelines.
Read the detailed description
Glaucoma is a leading cause of blindness and visual impairment in the United States, particularly among disadvantaged populations. Despite the presence of therapies proven in NEI, randomized controlled trials that can be delivered by more than 18,000 ophthalmologists and 34,000 optometrists, almost nothing is known about the content and quality of glaucoma care delivered by non-MD providers such as optometrists. With the numbers of people with glaucoma expected to more than double in the next twenty years in the face of no more than a 15% increase in the supply of eye care providers, methods to better support appropriate and high-quality care for chronic eye diseases such as glaucoma delivered by optometrists will become as critical, if not more so, as techniques to enhance quality care among ophthalmologists.
Our study is a community-based, randomized, controlled trial that evaluates the suitability and effectiveness of a technology-based (tablet computer) intervention within the context of a novel partnership between optometrists and patients with glaucoma to improve the process quality of care and ultimately outcomes of care. By using successfully implemented technology in novel applications,and by building on the success of ongoing community-based quality improvement projects in our region, the study provides a means for rapid translation into community care if the intervention is successful.
- Conditions
- Glaucoma
- Being tested
- Computer Tablet, Continuing Education Course, Continuing education
- Keywords
- glaucoma, optometrists
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer TabletOther
A tablet computer based software application designed to collect structured clinical information from providers and patients at the point of care.
Continuing Education CourseOther
Annual standard continuing education
Continuing educationOther
Annual standard continuing education materials
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Other: Computer Tablet; Other: Continuing Education Course |
| 2 | Other | Control group to receive annual continuing education Receives: Other: Continuing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if innovative technology will improve process quality of care & important outcomes of care by optometrists in a cost-efficient manner while simultaneously empowering & including patients as part of the care process.
Measured: Baseline, Year 1 and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- None (open label)
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Paul Lee, MD, JD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672048
- Sponsor's protocol ID
- Pro00002593
- Other IDs
- R01EY018405-01
- Status last verified
- Dec 2013
- First submitted
- 4 May 2008
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Silvey GM, Lobach DF, Macri JM, Hunt M, Kacmaz RO, Lee PP. User interface considerations for collecting data at the point of care in the tablet PC computing environment. AMIA Annu Symp Proc. 2006;2006:1096.
PubMed 17238715Silvey GM, Lobach DF, Macri JM, Hunt M, Kacmaz RO, Lee PP. Overcoming obstacles to collecting narrative data from eye care professionals at the point-of-care. AMIA Annu Symp Proc. 2005;2005:1116.
PubMed 16779403Kacmaz RO, Arbanas JM, Lee PP, Lobach DF. Assessment of relative importance of tablet computer features in supporting direct electronic documentation of encounters by eye care professionals. AMIA Annu Symp Proc. 2005;2005:1001.
PubMed 16779288Lobach DF, Silvey GM, Macri JM, Hunt M, Kacmaz RO, Lee PP. Identifying and overcoming obstacles to point-of-care data collection for eye care professionals. AMIA Annu Symp Proc. 2005;2005:465-9.
PubMed 16779083
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Quality Care for Glaucoma Through a Provider-Patient Partnership
- ClinicalTrials.gov ID
- NCT00672048
- Acronym / sponsor ID
- Pro00002593
- Conditions
- Glaucoma
- Keywords
- glaucoma, optometrists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Oct 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 May 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 develop new ways of assisting patients with glaucoma and their eye doctors in using the recommendations from practice guidelines.
Detailed description
Glaucoma is a leading cause of blindness and visual impairment in the United States, particularly among disadvantaged populations. Despite the presence of therapies proven in NEI, randomized controlled trials that can be delivered by more than 18,000 ophthalmologists and 34,000 optometrists, almost nothing is known about the content and quality of glaucoma care delivered by non-MD providers such as optometrists. With the numbers of people with glaucoma expected to more than double in the next twenty years in the face of no more than a 15% increase in the supply of eye care providers, methods to better support appropriate and high-quality care for chronic eye diseases such as glaucoma delivered by optometrists will become as critical, if not more so, as techniques to enhance quality care among ophthalmologists.
Our study is a community-based, randomized, controlled trial that evaluates the suitability and effectiveness of a technology-based (tablet computer) intervention within the context of a novel partnership between optometrists and patients with glaucoma to improve the process quality of care and ultimately outcomes of care. By using successfully implemented technology in novel applications,and by building on the success of ongoing community-based quality improvement projects in our region, the study provides a means for rapid translation into community care if the intervention is successful.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Computer Tablet, Other: Continuing Education Course |
| 2 | Other | Other: Continuing educationControl group to receive annual continuing education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of open angle glaucoma with documented visual field loss.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer TabletA tablet computer based software application designed to collect structured clinical information from providers and patients at the point of care. | Other | 1 |
| Continuing Education CourseAnnual standard continuing education | Other | 1 |
| Continuing educationAnnual standard continuing education materials | Other | 2 |
Primary outcome
To determine if innovative technology will improve process quality of care & important outcomes of care by optometrists in a cost-efficient manner while simultaneously empowering & including patients as part of the care process.
Time frame: Baseline, Year 1 and Year 2
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 Jan 2014.
- Background: PubMed 17238715Silvey GM, Lobach DF, Macri JM, Hunt M, Kacmaz RO, Lee PP. User interface considerations for collecting data at the point of care in the tablet PC computing environment. AMIA Annu Symp Proc. 2006;2006:1096.
- Background: PubMed 16779403Silvey GM, Lobach DF, Macri JM, Hunt M, Kacmaz RO, Lee PP. Overcoming obstacles to collecting narrative data from eye care professionals at the point-of-care. AMIA Annu Symp Proc. 2005;2005:1116.
- Background: PubMed 16779288Kacmaz RO, Arbanas JM, Lee PP, Lobach DF. Assessment of relative importance of tablet computer features in supporting direct electronic documentation of encounters by eye care professionals. AMIA Annu Symp Proc. 2005;2005:1001.
- Background: PubMed 16779083Lobach DF, Silvey GM, Macri JM, Hunt M, Kacmaz RO, Lee PP. Identifying and overcoming obstacles to point-of-care data collection for eye care professionals. AMIA Annu Symp Proc. 2005;2005:465-9.
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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.
Paul Lee, MD, JD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Tablet, Continuing Education Course and Continuing education in people with Glaucoma, run by Duke University 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 1 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 6 Jan 2014. 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?
To determine if innovative technology will improve process quality of care & important outcomes of care by optometrists in a cost-efficient manner while simultaneously empowering & including patients as part of the care process. (time frame: Baseline, Year 1 and Year 2). 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 NCT00672048, which also lists 4 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 6 Jan 2014.