GlaucomaGlaucomaAppNCT02659709

Interest in Electronic Applications for Patients With Glaucoma

An observational study of Glaucoma, run by Wills Eye at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluation interest in use of smartphone- and tablet-based application (app) for participants with glaucoma, ocular hypertension, those at risk and their caregivers. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Glaucoma
What is being tested?: Interest in medical education through social media
Type of treatment: Pill or oral medicine, Medical device
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Jun 2015to Oct 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Glaucoma patients or care givers

Who may be able to join

Anyone affected by glaucoma
Family and friends of someone with glaucoma

Who cannot join

unable to complete survey

Trial locations and contacts

1 site in 1 country.

United States1 site

Wills Eye Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Interest of Patients and Their Caregivers in A Smartphone- and Tablet-Based Application for Patients With Glaucoma

To evaluation interest in use of smartphone- and tablet-based application (app) for participants with glaucoma, ocular hypertension, those at risk and their caregivers.

Read the detailed description

This study is designed to determine the amount of interest in an educational application (app) on social media for glaucoma patients and their caregivers.

The purpose of this App is to enhance understanding of glaucoma by using short video tutorials. The App will include glaucoma eye drop medication reminders, a short video tutorial which aims to improve understanding of how visual field testing should be performed, how to administer eye drops and a feature that will enable participants to store and organize testing results using a mobile device.

Conditions: Glaucoma
Being tested: Interest in medical education through social media
Keywords: Glaucoma, Smartphone, Tablet, Application, Eye Drops
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interest in medical education through social mediaDevice
Also called Glaucoma App Interest
Measuring interest in social media technology designed to educate glaucoma patients about disease, testing, and treatments with reminders for taking medications.

Study groups in NCT02659709
Study group	Role	What they receive
Glaucoma Patients and Caregivers		Glaucoma patients and caregivers will complete a 20 item questionnaire providing demographic information, glaucoma eye drop compliance, interest in medication reminders, availability to smartphone, tablet and social media technology and interest in using a glaucoma application on social media. Receives: Device: Interest in medical education through social media

What is being measured

The primary outcome is the main question the study is designed to answer.

Patients Owning Smartphone/Tablet Technology
Responses collected from participants about owning access to social media via smartphone or tablet technology obtained by completing a 20 item questionnaire.
Measured: 1 hour
Patients Having Access to Social Media Via Smartphone or Tablet in the Home
Responses collected from participants about their personal access, through other members in the home, to social media via smartphone or tablet technology obtained by completing a 20 item questionnaire.
Measured: 1 hour

Secondary outcomes (2)

Glaucoma Medication Compliance
Responses collected from participants about compliance to using their glaucoma drops as prescribed obtained by completing a 20 item questionnaire.
Measured: 1 hour
Use of Medication Reminder
Responses collected from participants about use of medication reminders for their glaucoma drops obtained by completing a 20 item questionnaire.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Oct 2016

First posted20 Jan 2016 (estimated)
Study startJun 2015
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02659709
Sponsor's protocol ID: 14-413E
Acronym: GlaucomaApp
Status last verified: Jun 2019
First submitted: 6 Aug 2015
Last updated: 5 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Waisbourd M, Dhami H, Zhou C, Hsieh M, Abichandani P, Pro MJ, Moster MR, Katz LJ, Hark LA, Myers JS. The Wills Eye Glaucoma App: Interest of Patients and Their Caregivers in a Smartphone-based and Tablet-based Glaucoma Application. J Glaucoma. 2016 Sep;25(9):e787-91. doi: 10.1097/IJG.0000000000000504.
PubMed 27552513

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
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Glaucoma Drop Aids Part 2
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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma

All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interest of Patients and Their Caregivers in A Smartphone- and Tablet-Based Application for Patients With Glaucoma
ClinicalTrials.gov ID: NCT02659709
Acronym / sponsor ID: GlaucomaApp / 14-413E
Conditions: Glaucoma
Keywords: Glaucoma, Smartphone, Tablet, Application, Eye Drops
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Wills EyeUniversity, hospital or other
Study start: Jun 2015
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 20 Jan 2016 (estimated)
Results: Posted 5 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluation interest in use of smartphone- and tablet-based application (app) for participants with glaucoma, ocular hypertension, those at risk and their caregivers.

Detailed description

This study is designed to determine the amount of interest in an educational application (app) on social media for glaucoma patients and their caregivers.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Glaucoma Patients and Caregivers	–	Device: Interest in medical education through social mediaGlaucoma patients and caregivers will complete a 20 item questionnaire providing demographic information, glaucoma eye drop compliance, interest in medication reminders, availability to smartphone, tablet and social media technology and interest in using a glaucoma application on social media.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Glaucoma patients or care givers

Key inclusion criteria (2 listed)

Anyone affected by glaucoma
Family and friends of someone with glaucoma

Key exclusion criteria (1 listed)

unable to complete survey

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
Interest in medical education through social mediaAlso: Glaucoma App InterestMeasuring interest in social media technology designed to educate glaucoma patients about disease, testing, and treatments with reminders for taking medications.	Device	Glaucoma Patients and Caregivers

Primary outcome

Patients Owning Smartphone/Tablet Technology
Time frame: 1 hour
Responses collected from participants about owning access to social media via smartphone or tablet technology obtained by completing a 20 item questionnaire.
Patients Having Access to Social Media Via Smartphone or Tablet in the Home
Time frame: 1 hour
Responses collected from participants about their personal access, through other members in the home, to social media via smartphone or tablet technology obtained by completing a 20 item questionnaire.

2 secondary outcomes

Glaucoma Medication Compliance
Time frame: 1 hour
Use of Medication Reminder
Time frame: 1 hour

Results and safety

Results posted to the registry on 5 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glaucoma Patients and Caregivers	50	50

Primary outcome: Patients Owning Smartphone/Tablet Technology

Time frame: 1 hour. Count of participants. Unit: Participants

Measure	Glaucoma Smartphone Application n = 50
Value	34

Population analysed: Participants responding Yes to owning a smartphone or tablet.

Primary outcome: Patients Having Access to Social Media Via Smartphone or Tablet in the Home

Time frame: 1 hour. Count of participants. Unit: Participants

Measure	Glaucoma Smartphone Application n = 50
Value	39

Population analysed: Participants responding Yes to anyone in the house owning a smartphone or tablet.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 hour. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glaucoma Smartphone Application	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): Participants were recruited from single urban eye care hospital. Results did not distinguish between glaucoma patients and caregivers. Participation did not include testing of the application.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27552513Waisbourd M, Dhami H, Zhou C, Hsieh M, Abichandani P, Pro MJ, Moster MR, Katz LJ, Hark LA, Myers JS. The Wills Eye Glaucoma App: Interest of Patients and Their Caregivers in a Smartphone-based and Tablet-based Glaucoma Application. J Glaucoma. 2016 Sep;25(9):e787-91. doi: 10.1097/IJG.0000000000000504.
Individual participant dataSharing planned: No

Related trials for Glaucoma

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma

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.

Jonathan S Myers, MD principal investigator

Wills Eye Hospital

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 Glaucoma, run by Wills Eye 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 2 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: finished, as of the sponsor's last update on 5 Aug 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patients Owning Smartphone/Tablet Technology (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 NCT02659709, 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 5 Aug 2019.