Меню
Идёт набор NCT07707453

The COMET Study: a Prospective COhort of MEdical residenTs to Assess Professional, Personal and Psychological Trajectories of Residents in General Internal Medicine

Наблюдательное Burnout Syndrome Depression Disorder Insomnia Perceived Stress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Burnout Syndrome, Depression Disorder, Insomnia, Perceived Stress. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Introduction. Switzerland, like most Western countries, faces a paradox: an ageing, multimorbid population needs general internal medicine (GIM) physicians more than ever, yet fewer young doctors choose - and stay in - the specialty. Career decisions during residency are intertwined with well-being, mental and physical health, and work-life balance, and distress in training has been associated with depression, burnout, attrition and poorer patient care. Longitudinal data following GIM residents across these domains, and linking them to actual career trajectories, are lacking. The COMET study establishes a multicentre prospective cohort of GIM residents to fill this gap. Methods and analysis. COMET is a prospective, open, multicentre cohort conducted in the departments of (general) internal medicine of Fribourg Hospital (HFR, four sites), Bern University Hospital (Inselspital) and Lausanne University Hospital (CHUV). All GIM residents providing direct patient care are eligible (≈334 residents; expected enrolment ≥267, assuming 80% participation). Participants complete an annual online survey (REDCap; French or German) at baseline and for at least four years, covering sociodemographics; job characteristics; career intentions and 24 factors for or against a GIM career; well-being (Physician Well-Being Index, Professional Fulfillment Index, quality of life, work-life balance); mental health (CES-D, Perceived Stress Scale, Maslach Burnout Inventory, Questionnaire of Cognitive and Affective Empathy); and physical health (step counts, physical activity, fatigue, sleep, healthcare utilisation). Primary endpoints are the longitudinal course of well-being and distress (PWBI, PFI, CES-D) and residents' career trajectory. Analyses combine descriptive statistics, mixed-effects and regression models, and comparisons with the population-based CoLaus\|PsyCoLaus cohort.

Первичные конечные точки

  • Change from baseline in psychological distress measured by the Physician Well-Being Index (PWBI) [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in professional fulfilment measured by the Professional Fulfillment Index (PFI) - professional fulfilment subscale [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in burnout measured by the Professional Fulfillment Index (PFI) - burnout composite [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in depressive symptoms measured by the Center for Epidemiologic Studies-Depression scale (CES-D) [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Percentage of participants remaining in general internal medicine training or practice [Срок оценки: Annually at years 1, 2, 3, 4 and 5]
  • Intention to leave direct patient care, measured on a single-item 5-point scale [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
Вторичные конечные точки (12)
  • Change from baseline in self-rated work-life balance (single-item 5-point scale) [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS-10) [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in work exhaustion measured by the Professional Fulfillment Index (PFI) - work-exhaustion subscale [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in interpersonal disengagement measured by the Professional Fulfillment Index (PFI) - interpersonal-disengagement subscale [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in cognitive empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - cognitive empathy subscale [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in affective empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - affective empathy subscale [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in daily step count (smartphone-derived) [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in self-reported physical activity measured by the International Physical Activity Questionnaire - short form (IPAQ-SF) [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in fatigue measured by the Chalder Fatigue Scale [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in insomnia severity measured by the Insomnia Severity Index (ISI) [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Mean rating of each of 31 career pull and push factors (adapted Hauer questionnaire) [Срок оценки: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Difference in CES-D depressive-symptom score between residents and age-matched general-population participants (CoLaus|PsyCoLaus) [Срок оценки: Baseline]

Критерии участия

Критерии включения

Resident physician in general internal medicine employed at a participating study site or annex centre during the recruitment period Written informed consent

Критерии исключения

Not providing direct patient care Severe mental or physical condition precluding informed consent or compliance with the protocol

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 3 центра
  • Inselspital - University Hospital — Bern
  • HFR - Hôpital Cantonal — Fribourg
  • CHUV - University Hospital — Lausanne

Идентификаторы

NCT: NCT07707453 · CERV-VD Project-ID 2024-00444

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗