Optimising General Practice Long COVID Care - an Educational Intervention.

NCT06765421 | Not Yet Recruiting

• 1 other identifier: R27255
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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)).

Conditions

Long COVID

Keywords

Feasibility Studies; General Practice; long COVID; Pilot Study; Medical Education

Outcome Measures

Primary Outcomes (1)

• 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.

  Focus groups (4 weeks), post intervention interviews (4 weeks).

Secondary Outcomes (3)

• Study engagement data

  12 weeks

• GP and patient demographics / medical details

  4 weeks

• Patients'scores on the COVID-19-YRS

  6 weeks

Study Arms (2)

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.

Behavioral: Intervention Group

Control group

NO INTERVENTION

Control group GPs will be asked to deliver care as usual for patients enrolled in the study.

Interventions

Intervention Group BEHAVIORAL

Intervention 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Walter Cullen, MD

  UCD NUI: University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Broughan, MSc

CONTACT

+353868928972; john.broughan@ucd.ie

Walter Cullen, MD

CONTACT

walter.cullen@ucd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 9, 2025
• Study Start: March 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2024-12