Optimising General Practice Long COVID Care - an Educational Intervention.

Официальное название

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

Обзор

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)).

Вмешательства

• Поведенческое Intervention Group
  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 p

Первичные конечные точки

• Qualitative data from focus groups and post-intervention interviews [Срок оценки: Focus groups (4 weeks), post intervention interviews (4 weeks).]

Вторичные конечные точки (3)

• Study engagement data [Срок оценки: 12 weeks]
• GP and patient demographics / medical details [Срок оценки: 4 weeks]
• Patients'scores on the COVID-19-YRS [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06765421 · R27255

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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