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

15 de julio de 2026 actualizado por: Marco Mancinetti, University of Fribourg

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Tipo de estudio

De observación

Inscripción (Estimado)

800

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Suiza
      • Bern, Suiza
        • Reclutamiento
        • Inselspital - University Hospital
        • Contacto:
      • Fribourg, Suiza, 1700
        • Reclutamiento
        • HFR - Hôpital cantonal
        • Contacto:
      • Lausanne, Suiza
        • Reclutamiento
        • CHUV - University Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

resident physicians in general internal medicine at approximately 22 Swiss hospital and ambulatory centres (~1,300 eligible)

Descripción

Inclusion Criteria:

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

Exclusion Criteria:

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Residents in General Internal Medicine (GIM)
All residents in GIM in the participating centers in Switzerland

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in psychological distress measured by the Physician Well-Being Index (PWBI)
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The Physician Well-Being Index (resident version) comprises 7 yes/no items referring to the past month. Total score ranges from 0 to 7; higher scores indicate greater distress (worse outcome). A score of 3 or higher identifies residents at risk of distress
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
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The professional fulfilment subscale of the Professional Fulfillment Index comprises 6 items scored 0-4 on 5-point scales (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater professional fulfilment (better outcome); scores of 3.0 or higher indicate professional fulfilment
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
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The burnout composite of the Professional Fulfillment Index comprises 10 items (4 work-exhaustion and 6 interpersonal-disengagement items) scored 0-4 on 5-point scales (past two weeks); the composite score is the item mean, ranging from 0 to 4. Higher scores indicate more severe burnout (worse outcome); scores of 1.33 or higher indicate burnout
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)
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The Center for Epidemiologic Studies-Depression scale comprises 20 items scored 0-3 by symptom frequency over the past week. Total score ranges from 0 to 60; higher scores indicate more depressive symptoms (worse outcome). A score of 16 or higher indicates clinically relevant depressive symptoms.
Baseline and annually at years 1, 2, 3, 4 and 5
Percentage of participants remaining in general internal medicine training or practice
Periodo de tiempo: Annually at years 1, 2, 3, 4 and 5
Proportion (%) of participants who, at each annual follow-up survey, report continuing postgraduate training or clinical activity in general internal medicine, versus having switched to another specialty or having left clinical medicine, assessed by structured self-report items (current work position and current specialty goal) of the annual COMET online survey
Annually at years 1, 2, 3, 4 and 5
Intention to leave direct patient care, measured on a single-item 5-point scale
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
Single self-report item of the annual COMET survey rating the likelihood of leaving direct patient care within five years, from 1 (none) to 5 (high). Higher scores indicate a stronger intention to quit (worse outcome)
Baseline and annually at years 1, 2, 3, 4 and 5

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in self-rated work-life balance (single-item 5-point scale)
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
Single self-report item rating the current balance between personal and professional life on a 5-point scale from 1 (very good) to 5 (very bad), as used by Keeton et al. Higher scores indicate a worse perceived work-life balance.
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)
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The 10-item Perceived Stress Scale, referring to the past month, with items scored 0-4. Total score ranges from 0 to 40; higher scores indicate greater perceived stress (worse outcome)
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
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The work-exhaustion subscale of the Professional Fulfillment Index comprises 4 items scored 0-4 (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater work exhaustion (worse outcome).
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
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
he interpersonal-disengagement subscale of the Professional Fulfillment Index comprises 6 items scored 0-4 (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater interpersonal disengagement (worse outcome)
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
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The cognitive empathy subscale of the QCAE comprises 19 items rated on 4-point agreement scales (1-4). Total score ranges from 19 to 76; higher scores indicate greater cognitive empathy (better outcome)
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
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The affective empathy subscale of the QCAE comprises 12 items rated on 4-point agreement scales (1-4). Total score ranges from 12 to 48; higher scores indicate greater affective empathy.
Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in daily step count (smartphone-derived)
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
Average number of steps per day, reported by participants from the default health application of their smartphone as monthly averages for the current month and the two previous months (unit: steps/day). Higher values indicate more physical activity
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)
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The IPAQ short form comprises 7 items covering vigorous activity, moderate activity, walking and sitting time over the past 7 days; responses are converted to metabolic equivalent of task (MET)-minutes per week according to the IPAQ scoring protocol. Higher values indicate more physical activity
Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in fatigue measured by the Chalder Fatigue Scale
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The Chalder Fatigue Scale comprises 11 items scored 0-3 (Likert scoring). Total score ranges from 0 to 33; higher scores indicate more severe fatigue (worse outcome).
Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in insomnia severity measured by the Insomnia Severity Index (ISI)
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
The Insomnia Severity Index comprises 7 items scored 0-4, referring to sleep problems over the past two weeks. Total score ranges from 0 to 28; higher scores indicate more severe insomnia (worse outcome)
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)
Periodo de tiempo: Baseline and annually at years 1, 2, 3, 4 and 5
Each of 31 factors potentially influencing a career in internal medicine is rated on a 5-point bipolar scale from 1 (very pushed away) to 5 (very attracted toward), adapted from Hauer et al. Mean scores per factor (range 1-5) describe the relative weight of attracting and repelling factors; higher scores indicate a more attracting influence.
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)
Periodo de tiempo: Baseline
Difference in mean Center for Epidemiologic Studies-Depression scale score (20 items, total 0-60; higher = more depressive symptoms) between COMET participants and participants aged 18-35 of the population-based CoLaus|PsyCoLaus cohort, using the identical instrument (unit: score points)
Baseline
Difference in QCAE empathy scores between residents and Swiss medical students
Periodo de tiempo: Baseline and year 5
Difference in mean QCAE cognitive (19-76) and affective (12-48) empathy subscale scores between COMET participants and published values from a national cohort of Swiss medical students, using the identical instrument (unit: score points; higher = greater empathy)
Baseline and year 5

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Fribourg

Colaboradores

University of Lausanne Hospitals
Hôpital Fribourgeois
Insel Gruppe AG, University Hospital Bern

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2025

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2031

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de julio de 2026

Publicado por primera vez (Actual)

16 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CERV-VD Project-ID 2024-00444

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Depends on the demand - as noted on the Research Project Collaboration Guidelines

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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