Clinical trial NCT06765421: Optimising General Practice Long COVID Care - an Educational Intervention.
Official title: Optimising General Practice Long COVID Care - Feasibility Trial of a Pilot Educational Intervention.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long COVID
Keywords: Feasibility Studies
General Practice
long COVID
Pilot Study
Medical Education
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: HRB Primary Care Clinical Trials Network Ireland
name: Mater Misericordiae University Hospital
name: Clinical Research Centre, School of Medicine, University College Dublin
name: School of Medicine, University College Dublin
name: School of Economics, University College Dublin
name: Irish College of General Practitioners
name: St Vincent's University Hospital
name: Health Services Executive, Ireland
name: South East Technological University, Ireland
name: National Rehabilitation Hospital, Dublin, Ireland
First posted: 2025-01-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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)).


Eligibility criteria: Inclusion Criteria:

1. Age: Aged 18 years or older at the time of enrolment.
2. Registration: Are registered as patients at the study's participating practices.
3. 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.
4. Persistent Symptoms:

   o Have spoken with their general practitioner (GP) about experiencing persistent symptoms lasting four weeks or more since their COVID-19 diagnosis.
5. Consent: Willing and able to provide informed consent to participate in the study.

Exclusion Criteria:

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.

Primary outcomes:
measure: Qualitative data from focus groups and post-intervention interviews
timeFrame: Focus groups (4 weeks), post intervention interviews (4 weeks).
Secondary outcomes:
measure: Study engagement data
timeFrame: 12 weeks
measure: GP and patient demographics / medical details
timeFrame: 4 weeks
measure: Patients'scores on the COVID-19-YRS
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: UCD NUI: University College Dublin
name: Walter Cullen, MD
role: PRINCIPAL_INVESTIGATOR
References: