Eye DiseasesNCT04404803
Motivations and Barriers to Participating in Ophthalmology Research Projects
An observational study of Eye Diseases, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The primary objective of this project is to understand the reasons why patients agree / disagree to take part in ophthalmology research. This will be done by asking participants to complete a Research Questionnaire. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eye Diseases
- What is being tested?
- questionnaire
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2019to Jan 2024
- Phase
- Observational
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria explicitly state otherwise.
Who may be able to join
- Over 16 years old
- Willing to participate by completing the questionnaire
- Must be able to speak and read English
Who cannot join
- Under 16 years of age
- Not willing to complete the questionnaire
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Monika Cien
Manchester, M13 9WL
Monika Cien, 01617011765 ext. 11765, monika.cien@mft.nhs.uk
About this study
The primary objective of this project is to understand the reasons why patients agree / disagree to take part in ophthalmology research. This will be done by asking participants to complete a Research Questionnaire.
- Conditions
- Eye Diseases
- Being tested
- questionnaire
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Patients will be asked to complete a questionnaire about the reasons why they agree / decline to take part in research.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of motivations to participating in ophthalmology research.
Questionnaire
Measured: 5 years
Assessment of barriers in participating in ophthalmology research
Questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start21 Jan 2019
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404803
- Sponsor's protocol ID
- B00366
- Status last verified
- Apr 2023
- First submitted
- 22 Nov 2018
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivations and Barriers to Participating in Ophthalmology Research Projects
- ClinicalTrials.gov ID
- NCT04404803
- Acronym / sponsor ID
- B00366
- Conditions
- Eye Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 28 May 2020 (actual)
- 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 primary objective of this project is to understand the reasons why patients agree / disagree to take part in ophthalmology research. This will be done by asking participants to complete a Research Questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria explicitly state otherwise.
Key inclusion criteria (3 listed)
- Over 16 years old
- Willing to participate by completing the questionnaire
- Must be able to speak and read English
Key exclusion criteria (2 listed)
- Under 16 years of age
- Not willing to complete the questionnaire
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 |
|---|---|---|
| questionnairePatients will be asked to complete a questionnaire about the reasons why they agree / decline to take part in research. | Other | – |
Primary outcome
Assessment of motivations to participating in ophthalmology research.
Time frame: 5 years
Questionnaire
Assessment of barriers in participating in ophthalmology research
Time frame: 5 years
Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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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.
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 Eye Diseases, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 2 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 26 Apr 2023. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monika Cien (01617011765 ext. 11765, monika.cien@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of motivations to participating in ophthalmology research. (time frame: 5 years). 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?
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 26 Apr 2023.