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NCT Number: NCT06765421

Optimising General Practice Long COVID Care - an 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.

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)).

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Key information

Conditions

Long COVID COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Intervention Group

Behavioral

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.

Primary outcomes

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.

Secondary outcomes

Study engagement data

Time frame: 12 weeks

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.
GP and patient demographics / medical details

Time frame: 4 weeks

Descriptive statistics and qualitative analysis of open-ended responses outlining practice, GP, and patient demographics, as well as patient medical details, will be conducted.
Patients'scores on the COVID-19-YRS

Time frame: 6 weeks

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.

Study contacts

Contact information is provided by the study sponsor or research team.

John M Broughan, MSc

CONTACT

[email protected]

+353868928972

Walter Cullen, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

HRB Primary Care Clinical Trials Network Ireland
Health Services Executive, Ireland
Irish College of General Practitioners
Mater Misericordiae University Hospital
National Rehabilitation Hospital, Dublin, Ireland (NRH)
South East Technological University, Ireland
St Vincent's University Hospital, Ireland

Registry information

Official study title

Optimising General Practice Long COVID Care - Feasibility Trial of a Pilot Educational Intervention.

Acronym: GP-COV-ED

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jan 9, 2025
Registry last updated: Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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