Long COVIDGP-COV-EDNCT06765421
Optimising General Practice Long COVID Care - an Educational Intervention.
A study testing Intervention Group in people with Long COVID, run by University College Dublin.
Trial summary
This trial will evaluate the feasibility of a pilot educational intervention for GPs that aims to enhance care and care outcomes among patients with long COVID at six general practices in the Ireland East region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Aged 18 years or older at the time of enrolment.
- Registration: Are registered as patients at the study's participating practices.
- COVID-19 Diagnosis:
- Previously received a positive COVID-19 PCR or antigen test, or
- Previously been clinically diagnosed with COVID-19 by a healthcare provider.
- Persistent Symptoms:
- o Have spoken with their general practitioner (GP) about experiencing persistent symptoms lasting four weeks or more since their COVID-19 diagnosis.
- Consent: Willing and able to provide informed consent to participate in the study.
Who cannot join
- 1. Vulnerability: Deemed by participating GPs to be a vulnerable individual whose best interests are served by not participating in the study, such as (but not limited to):
- People with language difficulties that prevent meaningful communication.
- Individuals with a recognised or diagnosed intellectual, physical, or mental impairment.
- Older adults considered particularly vulnerable.
- Individuals residing in institutions (e.g., care homes or prisons).
- Individuals with an unequal relationship with the researcher(s) (e.g., hierarchical dependence).
- Members of marginalised or disadvantaged groups for whom participation may present undue burden or risk.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Walter Cullen, MD contact
About this study
Official title: Optimising General Practice Long COVID Care - Feasibility Trial of a Pilot Educational Intervention.
This trial will evaluate the feasibility of a pilot educational intervention for GPs that aims to enhance care and care outcomes among patients with long COVID at six general practices in the Ireland East region.
Our first objective is to conduct focus groups with key stakeholders (GPs, other health professionals, patients, families/carers) that will inform the contents of an education intervention. The second objective will be to implement this educational intervention, and the third objective will be to determine whether the intervention is feasible.
Read more
Study outcomes will include:
- Qualitative findings from co-design focus groups and post-intervention semi-structured interviews with GPs.
- Practice and patient study recruitment and retention data.
- GP / Practice characteristics: age \& gender, practice location, general and COVID-19 patient population figures.
- Patient characteristics: Patient age, gender, COVID-19 vaccination status, and medical history details.
- Patient scores on a self-report measure assessing the symptoms, symptom severity, functional impact, and overall health (COVID-19 Yorkshire Rehabilitation Scale (C-19-YRS)).
- Conditions
- Long COVID
- Being tested
- Intervention Group
- Keywords
- Feasibility Studies, General Practice, long COVID, Pilot Study, Medical Education
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Intervention group activity involves three components:
- Intervention group GPs will be provided with a long COVID 'toolkit'. The toolkit will be prepared by the study team in collaboration with expert clinicians and public and patient representatives as a resource for GPs to use in patient care.
- GPs will attend an expert clinician / patient led long COVID educational session grounded in the findings of the toolkit.
- Applying learnings to date, each GP will conduct case reviews of eight patients with long COVID attending their practice and provide patient care as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | GP practices in the intervention group will be provided with a 'long COVID Toolkit for GPs', they will be invited to attend an long COVID educational webinar, and they will be asked to perform a detailed case review of patients enrolled in the study. Receives: Behavioral: Intervention Group |
| Control group | No intervention | Control group GPs will be asked to deliver care as usual for patients enrolled in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data from focus groups and post-intervention interviews
Qualitative analyses will be used to capture focus group and intervention participants' study related views and experiences, with emphasis on accounts illustrating the intervention's feasibility.
Measured: Focus groups (4 weeks), post intervention interviews (4 weeks).
Secondary outcomes (3)
Study engagement data
Descriptive statistics will assess trends relating to study invitation, commencement, and completion. Qualitative analysis will examine reasons for study exclusion, non-commencement, and non-completion.
Measured: 12 weeks
GP and patient demographics / medical details
Descriptive statistics and qualitative analysis of open-ended responses outlining practice, GP, and patient demographics, as well as patient medical details, will be conducted.
Measured: 4 weeks
Patients'scores on the COVID-19-YRS
Descriptive and inferential statistics outlining aggregated baseline and six-week follow-up scores on the The Covid-19 Yorkshire Rehabilitation Scale (C-19-YRS) will be calculated. The C19-YRS has four subscales concerned with the severity of patients' key symptoms, functional limitations, overall health, and additional symptoms. Each item is rated on a 0-10 numerical rating scale, where 0 represents the symptom not being present, and 10 represents the symptom being extremely severe or life disturbing.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- HRB Primary Care Clinical Trials Network Ireland, Mater Misericordiae University Hospital, Irish College of General Practitioners, St Vincent's University Hospital, Ireland, Health Service Executive, Ireland, South East Technological University, Ireland, National Rehabilitation Hospital, Dublin, Ireland (NRH)
- Responsible party
- Sponsor
- Investigators
- Walter Cullen, MD, Principal investigator, UCD NUI: University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765421
- Sponsor's protocol ID
- R27255
- Acronym
- GP-COV-ED
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising General Practice Long COVID Care - Feasibility Trial of a Pilot Educational Intervention.
- ClinicalTrials.gov ID
- NCT06765421
- Acronym / sponsor ID
- GP-COV-ED / R27255
- Conditions
- Long COVID
- Keywords
- Feasibility Studies, General Practice, long COVID, Pilot Study, Medical Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- HRB Primary Care Clinical Trials Network Ireland, Mater Misericordiae University Hospital, Irish College of General Practitioners, St Vincent's University Hospital, Ireland, Health Service Executive, Ireland, South East Technological University, Ireland, National Rehabilitation Hospital, Dublin, Ireland (NRH)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 9 Jan 2025 (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.
This trial will evaluate the feasibility of a pilot educational intervention for GPs that aims to enhance care and care outcomes among patients with long COVID at six general practices in the Ireland East region.
Our first objective is to conduct focus groups with key stakeholders (GPs, other health professionals, patients, families/carers) that will inform the contents of an education intervention. The second objective will be to implement this educational intervention, and the third objective will be to determine whether the intervention is feasible.
Study outcomes will include:
- Qualitative findings from co-design focus groups and post-intervention semi-structured interviews with GPs.
- Practice and patient study recruitment and retention data.
- GP / Practice characteristics: age \& gender, practice location, general and COVID-19 patient population figures.
- Patient characteristics: Patient age, gender, COVID-19 vaccination status, and medical history details.
- Patient scores on a self-report measure assessing the symptoms, symptom severity, functional impact, and overall health (COVID-19 Yorkshire Rehabilitation Scale (C-19-YRS)).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention GroupGP practices in the intervention group will be provided with a 'long COVID Toolkit for GPs', they will be invited to attend an long COVID educational webinar, and they will be asked to perform a detailed case review of patients enrolled in the study. |
| Control group | No intervention | –Control group GPs will be asked to deliver care as usual for patients enrolled in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: Aged 18 years or older at the time of enrolment.
- Registration: Are registered as patients at the study's participating practices.
- COVID-19 Diagnosis:
- Persistent Symptoms:
- o Have spoken with their general practitioner (GP) about experiencing persistent symptoms lasting four weeks or more since their COVID-19 diagnosis.
Key exclusion criteria (7 listed)
- 1. Vulnerability: Deemed by participating GPs to be a vulnerable individual whose best interests are served by not participating in the study, such as (but not limited to):
- People with language difficulties that prevent meaningful communication.
- Individuals with a recognised or diagnosed intellectual, physical, or mental impairment.
- Older adults considered particularly vulnerable.
- Individuals residing in institutions (e.g., care homes or prisons).
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 |
|---|---|---|
| Intervention GroupIntervention group activity involves three components: 1. Intervention group GPs will be provided with a long COVID 'toolkit'. The toolkit will be prepared by the study team in collaboration with expert clinicians and public and patient representatives as a resource for GPs to use in patient care. 2. GPs will attend an expert clinician / patient led long COVID educational session grounded in the findings of the toolkit. 3. Applying learnings to date, each GP will conduct case reviews of eight patients with long COVID attending their practice and provide patient care as appropriate. | Behavioural | Intervention group |
Primary outcome
Qualitative data from focus groups and post-intervention interviews
Time frame: Focus groups (4 weeks), post intervention interviews (4 weeks).
Qualitative analyses will be used to capture focus group and intervention participants' study related views and experiences, with emphasis on accounts illustrating the intervention's feasibility.
3 secondary outcomes
Study engagement data
Time frame: 12 weeks
GP and patient demographics / medical details
Time frame: 4 weeks
Patients'scores on the COVID-19-YRS
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Walter Cullen, MD contact
Walter Cullen, MD principal investigator
UCD NUI: University College Dublin
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Long COVID, run by University College Dublin.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M Broughan, MSc (+353868928972, john.broughan@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative data from focus groups and post-intervention interviews (time frame: Focus groups (4 weeks), post intervention interviews (4 weeks).). 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 9 Jan 2025.