Optimising General Practice Long COVID Care - an Educational Intervention.

Not Applicable

Not yet recruiting

• Conditions: Long COVID

• Registration Number: NCT06765421
• Lead Sponsor: University College Dublin

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)).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Study Start: 2025-03
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Qualitative data from focus groups and post-intervention interviews	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 Outcome Measures

Name	Time	Method
Study engagement data	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	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	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.