Health TrialsbyHealthPanel

Optimising General Practice Long COVID Care - an Educational Intervention.

ConditionLong COVID
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College Dublin

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age: Aged 18 years or older at the time of enrolment.

Registration: Are registered as patients at the study's participating practices.

Previously received a positive COVID-19 PCR or antigen test, or

Previously been clinically diagnosed with COVID-19 by a healthcare provider.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
4 weeks
3

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.

Time frame
6 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College Dublin

Lead sponsor

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: