Asthma Intermittent, UncontrolledNCT05829265
Feasibility of an Asthma Online Social Intervention
An observational study of Asthma Intermittent, Uncontrolled, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to test the feasibility and acceptability of an online intervention for people with troublesome asthma in primary care, involving a consultation with a primary care clinician to introduce and promote online peer support (i.e. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Asthma Intermittent, Uncontrolled
- What is being tested?
- A digital social intervention by primary care clinicians.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 526 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2022to 31 Aug 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Three to six general practices in North and East London will act as recruitment sites. In each practice, a GP or nurse will create a list of all adults with a diagnosis of asthma, who are not receiving palliative/end of life or institutional care. These adults will receive a text message inviting them to take part in the online questionnaire survey. Patients fulfilling the inclusion criteria will be identified, via the survey, and invited to receive the intervention. Eligible patients will be purposively sampled so that a range of ethnic/age groups, health literacy levels, ACT score ranges and co-existing conditions are represented in the cohort of patients receiving the intervention.
Who may be able to join
- Eligibility criteria for receiving the intervention in the feasibility study:
- Patients with a diagnosis of asthma indicated in online clinical records.
- Aged 16 years and above.
- Have expressed, in the questionnaire survey, interest in receiving a digital social intervention.
- Experience troublesome asthma (i.e. asthma control test (ACT) score of less than 20).
- Sufficiently fluent in English to take part in a consultation and subsequent data collection procedures.
- Competent to consent for themselves, as determined by a qualified primary care healthcare professional.
Who cannot join
- Patients who are
- Palliative or end-of-life.
- Receiving institutional long-term care (i.e. receiving total care in residential homes or living in nursing homes).
- Already a member of the ALUK OHC or other asthma OHCs/Facebook groups (general use of social media will not prevent participation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-randomised Feasibility Study Testing a Primary Care Intervention to Promote Engagement in an Online Health Community (OHC) for Adults With Troublesome Asthma
The goal of this observational study is to test the feasibility and acceptability of an online intervention for people with troublesome asthma in primary care, involving a consultation with a primary care clinician to introduce and promote online peer support (i.e. support from other patients with asthma within an established and safe OHC). The main questions this study aims to answer are:
- Is the intervention feasible and acceptable to patients?
- Can the research team recruit patients and collect health-related data to identify the impact of this intervention on patients and what are the challenges to pursue further research to evaluate this intervention in a trial?
Read the detailed description
This observational study will involve a non-randomised, mixed-methods, feasibility study, setting out to test and refine a digital social intervention for people with troublesome asthma in primary care. The feasibility study will consist of a number of steps, including a questionnaire survey to identify and recruit eligible patients, intervention delivery, collection of follow-up outcomes, and exit one-to-one interviews with a sample of patients and primary care clinicians. Provided the feasibility study is successful, there are plans to undertake a full randomised controlled trial.
The precise content of the survey is currently being co-developed with stakeholders. However, the research team envisages including questions about participants' demographic and socioeconomic data, asthma symptoms, control and self-management, quality of life, mental wellbeing, health literacy, and interest in digital social interventions. Completion of the survey should take around 15 minutes.
Eligible patients identified through the survey will be invited to receive the intervention (see 'Groups and Interventions' section below). The exact content of the intervention is still being co-developed with patients and clinicians. Clinicians delivering the intervention will be thoroughly trained (through an online workshop/session) on the practicalities of signing patients up to an OHC, including on seeking and recording consent and collecting baseline data. The precise content of training is still being developed in collaboration with various stakeholders.
A number of outcomes, both self-reported and non-self-reported by patients, will be collected (see 'Outcome measures' section below). The self-reported outcome variables will be collected, via an online form designed on RedCap software, at baseline and at six months following the intervention. For the baseline collection, clinicians will add patients' responses to the online form at the time of delivering the intervention. For the follow-up collection, participants will receive a link to the online form, via a text message from the practice with which participants are registered, for self-submission (form completion should take 10-15 minutes).
A sample of patients and clinicians will be invited to participate in a one-to-one, semi-structured interview. Clinicians will be interviewed shortly after delivering the intervention to all recruited patients, whereas patients will be interviewed at the end of the feasibility study (i.e. after the completion of the follow-up period). An interview topic guide composed of open-ended questions and prompts will be used to elicit experiences of delivering/receiving the intervention. Based on individual participants' preferences, interviews will take place either in person (within private meeting or consultation spaces in the general practices) or virtually (via Zoom platform). Interviews should last approximately 30-90 minutes, depending on how much each participant has to share, and will be audio recorded through digital recorders or by using the Cloud function in Zoom. Basic demographic data will be collected at the time of the interview.
- Conditions
- Asthma Intermittent, Uncontrolled
- Being tested
- A digital social intervention by primary care clinicians.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A digital social intervention by primary care clinicians.Behavioural
The intervention in this study will involve a structured consultation with a primary care clinician (e.g. a general practitioner (GP) or practice nurse) to promote online peer support, followed by engagement with the OHC of the Asthma + Lung UK (ALUK) charity. The intervention will either be delivered in person (in the general practices) or virtually. The aim is for the intervention to involve a face-to-face, one-off consultation, lasting approximately 30 minutes, during which a primary care clinician will:
- Signpost and sign patients up to the ALUK OHC, by thoroughly explaining terms of conditions of use and providing log in details.
- Introduce norms and values for passive (just reading) and active (writing OHC posts) participation.
- Encourage seeking and offering self-management information and support, by emphasising that the OHC could be used ad hoc (e.g. when feeling unwell, or when there are information or emotional needs).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group in the feasibility study. | There will only be one group in the feasibility study (i.e. all 50 patients recruited will receive the intervention). Receives: Behavioral: A digital social intervention by primary care clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients on the asthma register in the recruited practices
The number of patients on the asthma register will be measured in each recruited general practice, by extracting this information from practice records.
Measured: Baseline
Number of: survey respondents, patients willing and unwilling to receive the intervention, participants who withdraw or have missing data
Number of survey respondents and patients willing and unwilling to receive the intervention will be calculated from survey data, whereas number of participants who withdraw or have missing data will be obtained from the study's database.
Measured: Through study completion, an average of 1 year
Characteristics of: survey respondents, patients willing and unwilling to receive the intervention, participants who withdraw or have missing data
Characteristics of survey respondents and patients willing and unwilling to receive the intervention will be obtained from survey data, whereas characteristics of participants who withdraw or have missing data will be obtained from the study's database.
Measured: Through study completion, an average of 1 year
Recruitment rate (i.e. proportion of asthma register and/or survey respondents interested in and eligible for the intervention)
This proportion will be calculated based on the survey data and clinical records in the general practices used as recruitment sites.
Measured: Through study completion, an average of 1 year
Uptake rate (i.e. proportion of eligible patients consenting to the intervention and/or actively or passively engaging in the online health community (OHC) for the duration of the study)
The proportion of patients consenting to the study will be calculated based on data from the survey and the study's database, whereas the proportion of patients engaging with the OHC will be calculated based on OHC activity data.
Measured: Through study completion, an average of 1 year
Retention rate (i.e. proportion of patients providing valid measures at the end of the follow-up period)
This proportion will be based on data from the study's database.
Measured: Through study completion, an average of 1 year
Proportion of missing data (by outcome measure)
This proportion will be based on data from the study's database.
Measured: Through study completion, an average of 1 year
Experience of patients receiving the intervention
Experiences of patients will be obtained via qualitative interviews with patients.
Measured: Patient experiences will be obtained through study completion (an average of 1 year).
Experience of clinicians delivering the intervention
Experiences of clinicians will be obtained via qualitative interviews with clinicians.
Measured: Clinician experiences will be obtained up to 24 weeks from study's commencement.
Secondary outcomes (24)
Control of asthma
Control of asthma will be self-reported by patients through an Asthma Control Test (ACT) questionnaire.
Measured: Baseline and at three months from intervention receipt.
Adherence to medications
Adherence to medications will be self-reported by patients through a MARS-10 questionnaire.
Measured: Baseline and at three months from intervention receipt.
Number of asthma exacerbations over last 3 months
Asthma exacerbations will be self-reported by patients through a bespoke question.
Measured: Baseline and at three months from intervention receipt.
Health-related quality of life
Health-related quality of life will be self-reported by patients through an EQ-5D-5L questionnaire.
Measured: Baseline and at three months from intervention receipt.
Primary and secondary care use over last 3 months
Care use will be self-reported by patients through a bespoke question.
Measured: Baseline and at three months from intervention receipt.
Time off work to seek care and/or due to asthma over last 3 months
Time off work will be self-reported by patients through a bespoke question.
Measured: Baseline and at three months from intervention receipt.
Depression
Depression will be self-reported by patients through a PHQ-8 questionnaire.
Measured: Baseline and at three months from intervention receipt.
Anxiety
Anxiety will be self-reported by patients through a GAD-7 questionnaire.
Measured: Baseline and at three months from intervention receipt.
Self-efficacy
Self-efficacy will be self-reported by patients through the General Self-Efficacy Scale.
Measured: Baseline and at three months from intervention receipt.
Amount of OHC engagement
Amount of engagement with OHC will be self-reported by patients through a bespoke question.
Measured: Three months post intervention receipt.
Type (passive versus active) of OHC engagement
Type of engagement with OHC will be self-reported by patients through a bespoke question.
Measured: Three months post intervention receipt.
Number of asthma exacerbations over last 3 months
Exacerbations will be obtained from general practice records and data from the British Health Service (NHS)
Measured: Baseline and at three months from intervention receipt
Primary and secondary healthcare service utilisation over last 3 months
Number of consultations in general practices, as well as number of hospital attendances and admissions, will be obtained from general practice records and data from NHS.
Measured: Baseline and at three months from intervention receipt
Costs associated with primary and secondary healthcare service utilisation over last 3 months
Costs associated with primary care and hospital attendances, as obtained from general practice records and NHS data, will be calculated through economic models.
Measured: Baseline and at three months from intervention receipt
Amount of time spent on the OHC
Amount of time spent on the OHC will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
Number of communities joined
Number of communities joined will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
Number of logins to the OHC
Number of logins will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
Number of likes on pages/posts within the OHC platform
Number of likes will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
Time spent on pages within the OHC
Time spent on pages will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
Public posts of the 50 participants within the OHC
Public posts will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
Time of each public post in the OHC by the 50 participants
Time of posts will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
Discussion thread of each public post in the OHC by the 50 participants
Discussion threads of each post will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
User details in each discussion thread in the OHC in which one of the 50 participants was involved
User details in each discussion thread will be provided to the research team by the manager of the ALUK OHC
Measured: Three months post intervention receipt
Time to deliver the intervention
This will be recorded by clinicians at the time of delivering the intervention.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start9 Dec 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma Intermittent, UncontrolledStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, City, University of London, University of Cambridge, University of Edinburgh, University of Nottingham, University of Surrey, St George's, University of London, Asthma UK
- Responsible party
- Sponsor
- Investigators
- Anna De Simoni, PhD, Principal investigator, Clinical Reader in Primary Care Research, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829265
- Sponsor's protocol ID
- 314672
- Status last verified
- Dec 2024
- First submitted
- 21 Feb 2023
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from individual participants will not be shared. Participants will not be individually identifiable from any research outputs. 'Pseudonymisation of data' will be the policy for ensuring confidentiality. All participants will be coded, by allocating them unique participation codes. The association between participation codes and names will be contained on a Word/Excel document and will be stored on a password-protected computer at Queen Mary University of London. Any electronic documents or hard copies of data collected from participants will only be accessible to the research team. Only members of the research team will have access to associations between names and participation codes. Every attempt will be made to pool/aggregate or coarsely categorise potentially identifiable information in any dissemination of research findings.
Publications
Karampatakis GD, Wood HE, Griffiths CJ, Taylor SJC, Toffolutti V, Bird VJ, Lea NC, Ashcroft RE, Day B, Coulson NS, Panzarasa P, Li X, Sheikh A, Relton C, Sastry N, Watson JS, Marsh V, Mant J, Mihaylova B, Walker N, De Simoni A. Non-randomised feasibility study testing a primary care intervention to promote engagement in an online health community for adults with troublesome asthma: protocol. BMJ Open. 2023 Jul 11;13(7):e073503. doi: 10.1136/bmjopen-2023-073503.
PubMed 37433727Karampatakis GD, Wood HE, Griffiths CJ, Lea NC, Ashcroft RE, Day B, Walker N, Coulson NS, De Simoni A. Ethical and Information Governance Considerations for Promoting Digital Social Interventions in Primary Care. J Med Internet Res. 2023 Sep 27;25:e44886. doi: 10.2196/44886.
PubMed 37756051
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomised Feasibility Study Testing a Primary Care Intervention to Promote Engagement in an Online Health Community (OHC) for Adults With Troublesome Asthma
- ClinicalTrials.gov ID
- NCT05829265
- Acronym / sponsor ID
- 314672
- Conditions
- Asthma Intermittent, Uncontrolled
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, City, University of London, University of Cambridge, University of Edinburgh, University of Nottingham, University of Surrey, St George's, University of London, Asthma UK
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 25 Apr 2023 (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 goal of this observational study is to test the feasibility and acceptability of an online intervention for people with troublesome asthma in primary care, involving a consultation with a primary care clinician to introduce and promote online peer support (i.e. support from other patients with asthma within an established and safe OHC). The main questions this study aims to answer are:
- Is the intervention feasible and acceptable to patients?
- Can the research team recruit patients and collect health-related data to identify the impact of this intervention on patients and what are the challenges to pursue further research to evaluate this intervention in a trial?
Detailed description
This observational study will involve a non-randomised, mixed-methods, feasibility study, setting out to test and refine a digital social intervention for people with troublesome asthma in primary care. The feasibility study will consist of a number of steps, including a questionnaire survey to identify and recruit eligible patients, intervention delivery, collection of follow-up outcomes, and exit one-to-one interviews with a sample of patients and primary care clinicians. Provided the feasibility study is successful, there are plans to undertake a full randomised controlled trial.
The precise content of the survey is currently being co-developed with stakeholders. However, the research team envisages including questions about participants' demographic and socioeconomic data, asthma symptoms, control and self-management, quality of life, mental wellbeing, health literacy, and interest in digital social interventions. Completion of the survey should take around 15 minutes.
Eligible patients identified through the survey will be invited to receive the intervention (see 'Groups and Interventions' section below). The exact content of the intervention is still being co-developed with patients and clinicians. Clinicians delivering the intervention will be thoroughly trained (through an online workshop/session) on the practicalities of signing patients up to an OHC, including on seeking and recording consent and collecting baseline data. The precise content of training is still being developed in collaboration with various stakeholders.
A number of outcomes, both self-reported and non-self-reported by patients, will be collected (see 'Outcome measures' section below). The self-reported outcome variables will be collected, via an online form designed on RedCap software, at baseline and at six months following the intervention. For the baseline collection, clinicians will add patients' responses to the online form at the time of delivering the intervention. For the follow-up collection, participants will receive a link to the online form, via a text message from the practice with which participants are registered, for self-submission (form completion should take 10-15 minutes).
A sample of patients and clinicians will be invited to participate in a one-to-one, semi-structured interview. Clinicians will be interviewed shortly after delivering the intervention to all recruited patients, whereas patients will be interviewed at the end of the feasibility study (i.e. after the completion of the follow-up period). An interview topic guide composed of open-ended questions and prompts will be used to elicit experiences of delivering/receiving the intervention. Based on individual participants' preferences, interviews will take place either in person (within private meeting or consultation spaces in the general practices) or virtually (via Zoom platform). Interviews should last approximately 30-90 minutes, depending on how much each participant has to share, and will be audio recorded through digital recorders or by using the Cloud function in Zoom. Basic demographic data will be collected at the time of the interview.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group in the feasibility study. | – | Behavioral: A digital social intervention by primary care clinicians.There will only be one group in the feasibility study (i.e. all 50 patients recruited will receive the intervention). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three to six general practices in North and East London will act as recruitment sites. In each practice, a GP or nurse will create a list of all adults with a diagnosis of asthma, who are not receiving palliative/end of life or institutional care. These adults will receive a text message inviting them to take part in the online questionnaire survey. Patients fulfilling the inclusion criteria will be identified, via the survey, and invited to receive the intervention. Eligible patients will be purposively sampled so that a range of ethnic/age groups, health literacy levels, ACT score ranges and co-existing conditions are represented in the cohort of patients receiving the intervention.
Key inclusion criteria (7 listed)
- Patients with a diagnosis of asthma indicated in online clinical records.
- Aged 16 years and above.
- Have expressed, in the questionnaire survey, interest in receiving a digital social intervention.
- Experience troublesome asthma (i.e. asthma control test (ACT) score of less than 20).
- Sufficiently fluent in English to take part in a consultation and subsequent data collection procedures.
Key exclusion criteria (4 listed)
- Patients who are
- Palliative or end-of-life.
- Receiving institutional long-term care (i.e. receiving total care in residential homes or living in nursing homes).
- Already a member of the ALUK OHC or other asthma OHCs/Facebook groups (general use of social media will not prevent participation).
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 |
|---|---|---|
| A digital social intervention by primary care clinicians.The intervention in this study will involve a structured consultation with a primary care clinician (e.g. a general practitioner (GP) or practice nurse) to promote online peer support, followed by engagement with the OHC of the Asthma + Lung UK (ALUK) charity. The intervention will either be delivered in person (in the general practices) or virtually. The aim is for the intervention to involve a face-to-face, one-off consultation, lasting approximately 30 minutes, during which a primary care clinician will: * Signpost and sign patients up to the ALUK OHC, by thoroughly explaining terms of conditions of use and providing log in details. * Introduce norms and values for passive (just reading) and active (writing OHC posts) participation. * Encourage seeking and offering self-management information and support, by emphasising that the OHC could be used ad hoc (e.g. when feeling unwell, or when there are information or emotional needs). | Behavioural | Intervention group in the feasibility study. |
Primary outcome
Number of patients on the asthma register in the recruited practices
Time frame: Baseline
The number of patients on the asthma register will be measured in each recruited general practice, by extracting this information from practice records.
Number of: survey respondents, patients willing and unwilling to receive the intervention, participants who withdraw or have missing data
Time frame: Through study completion, an average of 1 year
Number of survey respondents and patients willing and unwilling to receive the intervention will be calculated from survey data, whereas number of participants who withdraw or have missing data will be obtained from the study's database.
Characteristics of: survey respondents, patients willing and unwilling to receive the intervention, participants who withdraw or have missing data
Time frame: Through study completion, an average of 1 year
Characteristics of survey respondents and patients willing and unwilling to receive the intervention will be obtained from survey data, whereas characteristics of participants who withdraw or have missing data will be obtained from the study's database.
Recruitment rate (i.e. proportion of asthma register and/or survey respondents interested in and eligible for the intervention)
Time frame: Through study completion, an average of 1 year
This proportion will be calculated based on the survey data and clinical records in the general practices used as recruitment sites.
Uptake rate (i.e. proportion of eligible patients consenting to the intervention and/or actively or passively engaging in the online health community (OHC) for the duration of the study)
Time frame: Through study completion, an average of 1 year
The proportion of patients consenting to the study will be calculated based on data from the survey and the study's database, whereas the proportion of patients engaging with the OHC will be calculated based on OHC activity data.
Retention rate (i.e. proportion of patients providing valid measures at the end of the follow-up period)
Time frame: Through study completion, an average of 1 year
This proportion will be based on data from the study's database.
Proportion of missing data (by outcome measure)
Time frame: Through study completion, an average of 1 year
This proportion will be based on data from the study's database.
Experience of patients receiving the intervention
Time frame: Patient experiences will be obtained through study completion (an average of 1 year).
Experiences of patients will be obtained via qualitative interviews with patients.
Experience of clinicians delivering the intervention
Time frame: Clinician experiences will be obtained up to 24 weeks from study's commencement.
Experiences of clinicians will be obtained via qualitative interviews with clinicians.
24 secondary outcomes
Control of asthma
Time frame: Baseline and at three months from intervention receipt.
Adherence to medications
Time frame: Baseline and at three months from intervention receipt.
Number of asthma exacerbations over last 3 months
Time frame: Baseline and at three months from intervention receipt.
Health-related quality of life
Time frame: Baseline and at three months from intervention receipt.
Primary and secondary care use over last 3 months
Time frame: Baseline and at three months from intervention receipt.
Time off work to seek care and/or due to asthma over last 3 months
Time frame: Baseline and at three months from intervention receipt.
Depression
Time frame: Baseline and at three months from intervention receipt.
Anxiety
Time frame: Baseline and at three months from intervention receipt.
Self-efficacy
Time frame: Baseline and at three months from intervention receipt.
Amount of OHC engagement
Time frame: Three months post intervention receipt.
Type (passive versus active) of OHC engagement
Time frame: Three months post intervention receipt.
Number of asthma exacerbations over last 3 months
Time frame: Baseline and at three months from intervention receipt
Primary and secondary healthcare service utilisation over last 3 months
Time frame: Baseline and at three months from intervention receipt
Costs associated with primary and secondary healthcare service utilisation over last 3 months
Time frame: Baseline and at three months from intervention receipt
Amount of time spent on the OHC
Time frame: Three months post intervention receipt
Number of communities joined
Time frame: Three months post intervention receipt
Number of logins to the OHC
Time frame: Three months post intervention receipt
Number of likes on pages/posts within the OHC platform
Time frame: Three months post intervention receipt
Time spent on pages within the OHC
Time frame: Three months post intervention receipt
Public posts of the 50 participants within the OHC
Time frame: Three months post intervention receipt
Time of each public post in the OHC by the 50 participants
Time frame: Three months post intervention receipt
Discussion thread of each public post in the OHC by the 50 participants
Time frame: Three months post intervention receipt
User details in each discussion thread in the OHC in which one of the 50 participants was involved
Time frame: Three months post intervention receipt
Time to deliver the intervention
Time frame: Baseline
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 24 Dec 2024.
- Background: PubMed 37433727Karampatakis GD, Wood HE, Griffiths CJ, Taylor SJC, Toffolutti V, Bird VJ, Lea NC, Ashcroft RE, Day B, Coulson NS, Panzarasa P, Li X, Sheikh A, Relton C, Sastry N, Watson JS, Marsh V, Mant J, Mihaylova B, Walker N, De Simoni A. Non-randomised feasibility study testing a primary care intervention to promote engagement in an online health community for adults with troublesome asthma: protocol. BMJ Open. 2023 Jul 11;13(7):e073503. doi: 10.1136/bmjopen-2023-073503.
- Background: PubMed 37756051Karampatakis GD, Wood HE, Griffiths CJ, Lea NC, Ashcroft RE, Day B, Walker N, Coulson NS, De Simoni A. Ethical and Information Governance Considerations for Promoting Digital Social Interventions in Primary Care. J Med Internet Res. 2023 Sep 27;25:e44886. doi: 10.2196/44886.
- Individual participant dataSharing planned: No. Data from individual participants will not be shared. Participants will not be individually identifiable from any research outputs. 'Pseudonymisation of data' will be the policy for ensuring confidentiality. All participants will be coded, by allocating them unique participation codes. The association between participation codes and names will be contained on a Word/Excel document and will be stored on a password-protected computer at Queen Mary University of London. Any electronic documents or hard copies of data collected from participants will only be accessible to the research team. Only members of the research team will have access to associations between names and participation codes. Every attempt will be made to pool/aggregate or coarsely categorise potentially identifiable information in any dissemination of research findings.
Related trials for Asthma Intermittent, Uncontrolled
Recruiting
Εffectiveness of a Digital Social Intervention in Primary Care
Asthma Intermittent, Uncontrolled
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.
Anna De Simoni, PhD principal investigator
Clinical Reader in Primary Care Research, Queen Mary University of London
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 Asthma Intermittent, Uncontrolled, run by Queen Mary University of London 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 7 inclusion and 4 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 24 Dec 2024. 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 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?
Number of patients on the asthma register in the recruited practices (time frame: Baseline). The study lists 9 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 NCT05829265, which also lists 2 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 24 Dec 2024.