Peer GroupI-CareNCT04809961
Longitudinal Observation of NHS Staff Wellbeing Following Introduction of the I-care Peer Support App
An observational study of Peer Group, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peer Group
- What is being tested?
- I-care app
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 1 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All staff within a single UK Health Trust with an android mobile phone will be considered eligible to use the app.
Who may be able to join
- All staff within a single UK Health Trust with an android mobile phone will be considered eligible to use the app
Who cannot join
- Not employed within the designated Trust
- Under 18 years of age
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Observation of United Kingdom NHS Staff Wellbeing Following Introduction of the I-care Peer Support App
The coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities affected by coronavirus. There is a need to find innovative solutions to facilitate support in the post-COVID-19 era and some innovations are emerging to fill this void but an evidence, long-term, sustainable, solution is yet to be proposed. In response, a digital app has been co-developed by UK researchers and healthcare staff with the intent to facilitate a virtual peer support mechanism for National Health Service (NHS) staff.
Read the detailed description
Rationale: The coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities affected by coronavirus. There is a need to find innovative solutions to facilitate support in the post-COVID-19 era and some innovations are emerging to fill this void but an evidence, long-term, sustainable, solution is yet to be proposed. In response, a digital app has been co-developed by UK researchers and healthcare staff with the intent to facilitate a virtual peer support mechanism for National Health Service (NHS) staff.
Aim: The main aim of this research is to determine the acceptability and efficacy of the newly developed I-care app to facilitate peer-support for NHS staff wellbeing.
Methods: A mixed methods study with concurrent process evaluation will be conducted to explore the acceptability and efficacy of an app-based peer support platform for use by anyone working within Solent NHS Trust with access to an android mobile phone device. Data will be generated from quantitative app usage, binary survey responses, and qualitative interviews.
Populations: All staff within Solent NHS Trust with an android mobile phone will be considered eligible to use the app.
Duration: Data will be collected at one, three, six, and 12-months post app launch.
Expected outcomes: As the innovation developed has spanned biomedical, behavioural and computing science a range of exploratory methods are proposed to establish the reach and uptake of the innovation, early indication of a potential causal model explaining how the innovation could lead to benefit, identification of key components of the innovation as identified by end users, and estimation of overall acceptability and efficacy.
- Conditions
- Peer Group
- Being tested
- I-care app
- Keywords
- peer support, healthcare workforce, wellbeing, digital health, app
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-care appOther
A smart phone app to enable healthcare worker peer support for improved workplace wellbeing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellbeing
Most frequent response (A/B/C).
Measured: 12 months
Secondary outcomes (1)
Engagement
Number of participants who have provided a rating
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion1 Jul 2022
Why it stopped: Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer GroupStudies 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Solent NHS Trust
- Responsible party
- Sponsor
- Investigators
- Lindsey Cherry, PhD, Principal investigator, University of Southampton & Solent NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809961
- Sponsor's protocol ID
- 61764
- Acronym
- I-Care
- Status last verified
- Nov 2022
- First submitted
- 2 Feb 2021
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observation of United Kingdom NHS Staff Wellbeing Following Introduction of the I-care Peer Support App
- ClinicalTrials.gov ID
- NCT04809961
- Acronym / sponsor ID
- I-Care / 61764
- Conditions
- Peer Group
- Keywords
- peer support, healthcare workforce, wellbeing, digital health, app
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Solent NHS Trust
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 22 Mar 2021 (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 coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities affected by coronavirus. There is a need to find innovative solutions to facilitate support in the post-COVID-19 era and some innovations are emerging to fill this void but an evidence, long-term, sustainable, solution is yet to be proposed. In response, a digital app has been co-developed by UK researchers and healthcare staff with the intent to facilitate a virtual peer support mechanism for National Health Service (NHS) staff.
Detailed description
Rationale: The coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities affected by coronavirus. There is a need to find innovative solutions to facilitate support in the post-COVID-19 era and some innovations are emerging to fill this void but an evidence, long-term, sustainable, solution is yet to be proposed. In response, a digital app has been co-developed by UK researchers and healthcare staff with the intent to facilitate a virtual peer support mechanism for National Health Service (NHS) staff.
Aim: The main aim of this research is to determine the acceptability and efficacy of the newly developed I-care app to facilitate peer-support for NHS staff wellbeing.
Methods: A mixed methods study with concurrent process evaluation will be conducted to explore the acceptability and efficacy of an app-based peer support platform for use by anyone working within Solent NHS Trust with access to an android mobile phone device. Data will be generated from quantitative app usage, binary survey responses, and qualitative interviews.
Populations: All staff within Solent NHS Trust with an android mobile phone will be considered eligible to use the app.
Duration: Data will be collected at one, three, six, and 12-months post app launch.
Expected outcomes: As the innovation developed has spanned biomedical, behavioural and computing science a range of exploratory methods are proposed to establish the reach and uptake of the innovation, early indication of a potential causal model explaining how the innovation could lead to benefit, identification of key components of the innovation as identified by end users, and estimation of overall acceptability and efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All staff within a single UK Health Trust with an android mobile phone will be considered eligible to use the app.
Key inclusion criteria (1 listed)
- All staff within a single UK Health Trust with an android mobile phone will be considered eligible to use the app
Key exclusion criteria (3 listed)
- Not employed within the designated Trust
- Under 18 years of age
- Unable or unwilling to provide informed consent
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 |
|---|---|---|
| I-care appA smart phone app to enable healthcare worker peer support for improved workplace wellbeing. | Other | – |
Primary outcome
Wellbeing
Time frame: 12 months
Most frequent response (A/B/C).
1 secondary outcome
Engagement
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- 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.
Lindsey Cherry, PhD principal investigator
University of Southampton & Solent NHS Trust
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 Peer Group, run by University of Southampton 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 1 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: withdrawn, as of the sponsor's last update on 16 Nov 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Wellbeing (time frame: 12 months). 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 16 Nov 2022.