Data SharingNCT05298514
Data Sharing Project Part 2
An observational study of Data Sharing and Information Dissemination, run by King's College London.
Trial summary
Patient data from clinical records are increasingly recognised as a valuable resource and a number of global initiatives exist to promote and enable the sharing of data. However, some mental health service-users have expressed concerns about the use of their data by services, but these have not been explored in depth… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Data Sharing, Information Dissemination, Mental Health
- What is being tested?
- Not applicable - qualitative research study
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Nov 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: We want to capture the views of a broad range of service users who have used mental health services or have experienced mental health problems from diverse backgrounds (ethnicity, age and clinical diagnoses).
Who may be able to join
- Individuals who have experience of using mental health services or experienced mental health difficulties in the past.
- Aged 18 and above.
- Able to give informed consent.
- Ability to speak fluent English.
Who cannot join
- If identified through C4C, participants whose care team specify concerns regarding taking part in the study.
- People in whom significant concerns have been raised relating to risk, where risk refers to the extent to which an individual poses a threat to themselves (e.g. self-harm or suicidal intent).
- Inability to give informed consent, as judged by the clinician responsible for a service user's ongoing care, where applicable.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigating Service User Opinions on Sharing Levels of Personal Information
Patient data from clinical records are increasingly recognised as a valuable resource and a number of global initiatives exist to promote and enable the sharing of data. However, some mental health service-users have expressed concerns about the use of their data by services, but these have not been explored in depth and the acceptable limits of data sharing remain unclear. The purpose of the study is to present different approaches to data sharing, with examples taken from across the world, varying in levels of anonymity and amounts of data stored and shared, with a view to extracting relevant principles directly from mental health service users. The primary objective of this study is to understand from service-users the limits of acceptable pseudonymised data sharing and data collection methods. This will inform the wider scientific community about any emerging questions and issues on pseudonymised clinical data sharing. We aim to explore the level of benefit service-users would accept, in exchange for the level of pseudonymised data they provide. Additionally, this study aims to investigate what service-users consider "identifiable" data, for example whether they consider demographic or location data or purely their real name to be identifiable. This study will ensure service-user views are an integral contribution to future pseudonymised data sharing systems, maximising applicability and acceptability. This study will use qualitative methods, in the form of focus groups, to gather service-user views. Focus groups will consider what participants believe to be identifiable data, who should get access, how should individuals and/or companies get access, how should data be protected and whether these answers change if pertaining to mental health information. Focus group data will be analysed using thematic analysis. Themes produced will be presented to participants in a second focus group. Participants will be encouraged to expand or change anything.
- Conditions
- Data Sharing, Information Dissemination, Mental Health
- Being tested
- Not applicable - qualitative research study
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable - qualitative research studyOther
We are not delivering interventions. This is a qualitative study in the form of focus groups.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health service user opinions on clinical data sharing as explored through qualitative focus groups questions
To understand the requirements of service users, on issues such as privacy, usability, and acceptability of different tiers of data sharing. Furthermore, to investigate what service-users consider "identifiable" data, for example whether they consider identifiable data to be demographic information, location data (consisting of relative and absolute data) or purely their real name.
This will be achieved by conducting a focus group in which the participants will be asked about hypothetical models of data sharing and their opinions on it. This will be guided by a topic guide asking the following questions:
- What is data? What would you consider to be personally identifiable information?
- Who gets access?
- How should individuals and/or companies get access?
- How should data be protected? The focus group will be audio-recorded, transcribed and analysed (via thematic analysis) to answer the primary outcome.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study startMay 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data SharingStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Til Wykes, Clinical Doc, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298514
- Sponsor's protocol ID
- LRS/DP-21/22-26411
- Other IDs
- 310873
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Service User Opinions on Sharing Levels of Personal Information
- ClinicalTrials.gov ID
- NCT05298514
- Acronym / sponsor ID
- LRS/DP-21/22-26411
- Conditions
- Data Sharing, Information Dissemination, Mental Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 28 Mar 2022 (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.
Patient data from clinical records are increasingly recognised as a valuable resource and a number of global initiatives exist to promote and enable the sharing of data. However, some mental health service-users have expressed concerns about the use of their data by services, but these have not been explored in depth and the acceptable limits of data sharing remain unclear. The purpose of the study is to present different approaches to data sharing, with examples taken from across the world, varying in levels of anonymity and amounts of data stored and shared, with a view to extracting relevant principles directly from mental health service users. The primary objective of this study is to understand from service-users the limits of acceptable pseudonymised data sharing and data collection methods. This will inform the wider scientific community about any emerging questions and issues on pseudonymised clinical data sharing. We aim to explore the level of benefit service-users would accept, in exchange for the level of pseudonymised data they provide. Additionally, this study aims to investigate what service-users consider "identifiable" data, for example whether they consider demographic or location data or purely their real name to be identifiable. This study will ensure service-user views are an integral contribution to future pseudonymised data sharing systems, maximising applicability and acceptability. This study will use qualitative methods, in the form of focus groups, to gather service-user views. Focus groups will consider what participants believe to be identifiable data, who should get access, how should individuals and/or companies get access, how should data be protected and whether these answers change if pertaining to mental health information. Focus group data will be analysed using thematic analysis. Themes produced will be presented to participants in a second focus group. Participants will be encouraged to expand or change anything.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We want to capture the views of a broad range of service users who have used mental health services or have experienced mental health problems from diverse backgrounds (ethnicity, age and clinical diagnoses).
Key inclusion criteria (4 listed)
- Individuals who have experience of using mental health services or experienced mental health difficulties in the past.
- Aged 18 and above.
- Able to give informed consent.
- Ability to speak fluent English.
Key exclusion criteria (3 listed)
- If identified through C4C, participants whose care team specify concerns regarding taking part in the study.
- People in whom significant concerns have been raised relating to risk, where risk refers to the extent to which an individual poses a threat to themselves (e.g. self-harm or suicidal intent).
- Inability to give informed consent, as judged by the clinician responsible for a service user's ongoing care, where applicable.
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 |
|---|---|---|
| Not applicable - qualitative research studyWe are not delivering interventions. This is a qualitative study in the form of focus groups. | Other | – |
Primary outcome
Mental health service user opinions on clinical data sharing as explored through qualitative focus groups questions
Time frame: Through study completion, an average of 1 year
To understand the requirements of service users, on issues such as privacy, usability, and acceptability of different tiers of data sharing. Furthermore, to investigate what service-users consider "identifiable" data, for example whether they consider identifiable data to be demographic information, location data (consisting of relative and absolute data) or purely their real name. This will be achieved by conducting a focus group in which the participants will be asked about hypothetical models of data sharing and their opinions on it. This will be guided by a topic guide asking the following questions: 1. What is data? What would you consider to be personally identifiable information? 2. Who gets access? 3. How should individuals and/or companies get access? 4. How should data be protected? The focus group will be audio-recorded, transcribed and analysed (via thematic analysis) to answer the primary outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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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.
Til Wykes, Clinical Doc principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
An observational study of Data Sharing and Information Dissemination, run by King's College London.
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 3 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 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Stephanie Luff (80423, stephanie.luff@slam.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health service user opinions on clinical data sharing as explored through qualitative focus groups questions (time frame: Through study completion, an average of 1 year). 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 28 Mar 2022.