- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07568977
A Tool of the Future for Strengthening Compassion in a Danish Hospital Setting.
A Tool of the Future for Strengthening Compassion in a Danish Hospital Setting
This study is a multi-phase, mixed-methods clinical investigation designed to examine the feasibility, validity, and organizational applicability of a structured measurement framework for assessing compassion in a Danish hospital setting. The study is conducted at Herlev and Gentofte Hospital and involves both patients and healthcare professionals across multiple clinical departments.
The study is structured in three sequential phases, each addressing distinct methodological and implementation components.
Phase 1 (Translation and Cultural Adaptation):
The initial phase involves the linguistic translation and cultural adaptation of three versions of the Sinclair Compassion Questionnaire (SCQ) and associated healthcare professional measures. This process follows established international guidelines for cross-cultural validation, including forward translation, back-translation, expert panel review, and pilot testing. Cognitive interviewing techniques are used to evaluate comprehension, relevance, and cultural appropriateness among both patients and healthcare professionals. Particular attention is given to semantic equivalence and the contextual meaning of key constructs across languages and professional groups.
Phase 1b (Psychometric Validation):
Following adaptation, the instruments are administered to a patient sample recruited from departments of anesthesia, surgery, and intensive care. Data collected in this phase are used to assess the psychometric properties of the translated instruments, including internal consistency, construct validity, factor structure, and measurement invariance. Statistical analyses include confirmatory factor analysis and reliability testing. The aim of this phase is to ensure that the instruments demonstrate robust measurement properties within the Danish healthcare context.
Phase 2 (Observational Implementation Study):
In the second phase, the validated instruments are implemented across four hospital departments, including medical, nephrology, orthopedic surgery, and emergency care. Data are collected from both patients and healthcare professionals to allow for multi-perspective analysis. In addition to questionnaire data, contextual variables such as demographic characteristics, professional background, and organizational factors are recorded. Administrative data, including sick leave and workforce indicators, are incorporated where available.
This phase employs a cross-sectional observational design with embedded comparative analyses across departments and professional groups. Multilevel modeling approaches are used to account for clustering within departments and to explore variation at individual and organizational levels. The design enables identification of patterns and differences across settings without introducing experimental manipulation.
Phase 3 (Contextualized Implementation and Development):
The third phase involves the application of findings from earlier phases to inform targeted implementation strategies. Rather than introducing a predefined intervention, this phase adopts an adaptive approach in which context-specific initiatives are selected or developed based on identified needs. This may include integration of existing training programs, workflow adjustments, or development of new tools. The implementation process is supported by interdisciplinary collaboration, including expertise in clinical practice, education, and organizational development.
Data Collection and Management:
Data are collected using secure electronic platforms compliant with Danish data protection regulations. All participant data are handled in accordance with GDPR requirements. Identifiable data are stored separately from research data, and access is restricted to authorized personnel. Data quality assurance procedures include validation checks and standardized data entry protocols.
Participant Involvement:
Patients are recruited during their contact with hospital departments and provide self-reported data through questionnaires. Healthcare professionals participate by completing self-assessment measures. Participation is voluntary, and no experimental interventions are administered.
Statistical Considerations:
The study uses both descriptive and inferential statistical methods. Psychometric analyses are conducted in Phase 1b, while Phase 2 includes regression analyses and multilevel modeling to examine associations between variables. Missing data are handled using appropriate statistical techniques, such as multiple imputation where relevant.
Ethical Considerations:
The study adheres to ethical guidelines for clinical research involving human participants. Informed consent is obtained from all participants. Participation does not influence clinical care or employment conditions. The study design minimizes participant burden by integrating data collection into existing clinical workflows where possible.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Compassion in healthcare is increasingly recognized as a multidimensional construct that influences patient experiences, clinical effectiveness, and workforce sustainability. However, the integration of compassion into routine clinical assessment remains limited due to a lack of standardized, context-sensitive measurement approaches. This study is designed to operationalize compassion within a hospital setting by systematically introducing and evaluating structured measurement instruments in real-world clinical practice.
The study is conducted at Herlev and Gentofte Hospital and follows a prospective, mixed-methods design with both cross-sectional and longitudinal components. It includes multiple clinical departments to ensure representation across different specialties, care intensities, and patient pathways. This diversity enables the assessment of compassion across heterogeneous contexts, including acute care, outpatient services, and longer-term treatment trajectories.
Participants include adult patients receiving care within participating departments and healthcare professionals employed in those units. Recruitment will occur consecutively to minimize selection bias and to reflect routine clinical populations. Healthcare professionals from various disciplines-including nursing staff, physicians, and allied health professionals-will be included to capture interdisciplinary perspectives on compassionate care delivery.
The study consists of several phases. The initial phase focuses on cultural and linguistic adaptation of the included measurement tools to ensure relevance and comprehensibility within a Danish healthcare context. This process includes translation, back-translation, and pilot testing with representative users. Feedback from this phase will inform minor adjustments to optimize clarity and usability.
The main data collection phase involves systematic administration of validated questionnaires to both patients and healthcare professionals. Patients will be invited to complete assessments in close temporal proximity to their care experience to reduce recall bias. Healthcare professionals will complete self-assessments at predefined intervals. Data collection will be facilitated through secure electronic platforms, with options for paper-based completion if needed to ensure inclusivity.
A longitudinal component is incorporated through repeated measurements over time. This allows for evaluation of temporal stability, responsiveness to organizational changes, and potential trends within and across departments. It also enables examination of how compassion-related measures evolve in relation to workplace conditions and clinical environments.
In parallel, a qualitative sub-study will be conducted to enrich interpretation of quantitative findings. Semi-structured interviews and focus groups with a purposive sample of patients and healthcare professionals will explore lived experiences, perceptions of compassionate care, and contextual factors influencing these experiences. This component will provide insight into mechanisms, barriers, and facilitators that are not captured through quantitative instruments alone.
Implementation processes will be systematically evaluated using principles from implementation science. Key domains include feasibility, acceptability, appropriateness, and integration into existing workflows. The study will examine how the introduction of compassion measurement tools interacts with organizational structures, leadership support, and daily clinical practice. Attention will also be given to potential unintended consequences, such as increased administrative burden or response fatigue.
Data analysis will include psychometric evaluation of measurement tools (e.g., internal consistency, construct validity, factor structure) and statistical modeling to explore patterns and associations within the data. Multilevel analytical approaches will be used to account for clustering at departmental levels. Longitudinal analyses will assess changes over time and potential predictors of variation in measured outcomes.
All data will be handled in compliance with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Participation is voluntary, and informed consent will be obtained from all participants. Data will be anonymized prior to analysis, and results will be reported at an aggregated level to ensure confidentiality.
By embedding structured assessment of compassion into routine clinical settings, this study aims to generate actionable knowledge on how compassion can be systematically understood, monitored, and supported in healthcare organizations. The findings are expected to contribute to the development of scalable approaches for integrating relational aspects of care into quality improvement frameworks, thereby supporting both patient-centered care and sustainable working conditions for healthcare professionals.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Camilla B. Sørensen, MD
- Numero di telefono: +45 21 35 77 43
- Email: camilla.birgitte.sorensen@regionh.dk
Backup dei contatti dello studio
- Nome: Nanja H. Hansen, Psychologist
- Numero di telefono: +45 21 35 77 43
- Email: nanja.holland.hansen@regionh.dk
Luoghi di studio
-
-
-
Herlev, Danimarca, 2630
- Reclutamento
- Herlev Gentofte Hospital
-
Contatto:
- Camilla Birgitte Soerensen, MD
- Numero di telefono: 004525671293
- Email: Camilla.Birgitte.Soerensen@regionh.dk
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Patients:
Inclusion Criteria:
- A patient at either the a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department (ED) d. Department of Orthopedic Surgery.Rheumatology and Orthopedics or e. Perioperative and Intensive Care Department
- Age 18-100+
- All genders
- Danish speaking
- Must have had contact with at least one healthcare professional before completing the questionnaire.
Exclusion Criteria:
- Patient exclusion criteria:
- Age 0-17
- Non-Danish speaking
- Not a patient at the a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department (ED) d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care)
- No contact with a healthcare professional
- Has answered the questionnaire before
Healthcare professionals:
HCP inclusion criteria
- Employed in one of the five departments included (phase 1b and 2): a. Department of Nephrology, b. Department of Internal Medicine c. Emergency Department, d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care.
- All genders
- Danish speaking
- Must have engaged with a patient
HCP exclusion criteria
- Not employed in one of the five departments included (a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department, d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care)
- Not Danish speaking
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Department cohorts
Cohort 1 with 5 subgroups
|
Patients are given the SCQ, healthcare providers are given the SCQ-ability and the SCQ-competence and the CBI
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sinclair Compassion Scale (SCQ)
Lasso di tempo: September 1st 2025 - July 31st 2027
|
An overall score is obtained by summing all individual items and calculating a single mean score, in which a higher final score is indicative of a greater experience of compassion.
|
September 1st 2025 - July 31st 2027
|
|
Sinclair Compassion Questionnaire -Health Care Professional Ability Self Assessment (SCQ-HCPASA)
Lasso di tempo: February 16th 2026 - July 31st 2027
|
The Sinclair Compassion Questionnaire -Health Care Professional Ability Self Assessment (SCQ-HCPASA) is a self-report questionnaire which measures health care professionals ability to provide compassionate care to their patients.
|
February 16th 2026 - July 31st 2027
|
|
Sinclair Compassion Questionnaire Health Care Professional Competence Self Assessment (SCQ-HCPCSA)
Lasso di tempo: February 16th 2026 - July 31st 2027
|
The Sinclair Compassion Questionnaire Health Care Professional Competence Self Assessment (SCQ-HCPCSA) is a self-report questionnaire that measures healthcare providers own competence in providing compassionate care
|
February 16th 2026 - July 31st 2027
|
|
Copenhagen Burnout Inventory (CBI)
Lasso di tempo: February 16th 2026 - July 31st 2027
|
The Copenhagen Burnout Inventory (CBI) is a self report questionnaire that measures healthcare professionels own experience of personal and work-related burnout.
|
February 16th 2026 - July 31st 2027
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Camilla B Sorensen, MD, Herlev Gentofte Hospital
- Investigatore principale: Nanja H Hansen, Psychologist, Herlev Gentofte Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CompassionHGH-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Bruciato
-
Fundacion Arturo Lopez PerezNon ancora reclutamentoSindrome da burnout | Burnout professionale
-
The Fourth Hospital of ShijiazhuangCompletatoBurnout professionaleCina
-
University Hospital, Basel, SwitzerlandCompletato
-
Ankara Yildirim Beyazıt UniversityAnkara Etlik City HospitalReclutamentoBurnout occupazionale | Abilità comunicative | Consapevolezza emotivaTurchia (Türkiye)
-
Second Affiliated Hospital, School of Medicine,...Non ancora reclutamentoBurnout occupazionale
-
Region SkaneLund University; Swedish Council for Working Life and Social Research; County Councils...Completato
-
University of PadovaUniversity of ChileCompletato
-
Hasanuddin UniversityCompletatoAuto-efficacia e Burnout Accademico tra gli Studenti di Scienze Motorie in Indonesia (BURNOUT-SE-26)Sindrome da burnout | AutoefficaciaIndonesia
-
University of Colorado, DenverMayo Clinic; Physicians FoundationReclutamento
-
Firstbeat Technologies OyTampere University; University of Jyvaskyla; Aisti Health OyAttivo, non reclutanteStress occupazionale | Burnout occupazionaleFinlandia
Prove cliniche su Sinclair Compassion Scale
-
Fondation Ophtalmologique Adolphe de RothschildCompletato
-
Cambridge Health AllianceReclutamento
-
Nanyang Technological UniversityHCA Hospice CareSconosciutoCure di fine vitaSingapore
-
Sunnybrook Health Sciences CentreCompletatoBurnout, Professionista | Stress Traumatico Secondario | Compassione StanchezzaCanada
-
Koç University HospitalCompletatoCompassione Stanchezza
-
University of CoimbraFundação para a Ciência e a TecnologiaSconosciuto
-
Robert SimpsonNon ancora reclutamentoSclerosi multipla | Auto compassioneCanada
-
London Metropolitan UniversityCompletatoDisturbi del dolore sessualeRegno Unito
-
University College DublinMater Misericordiae University Hospital; Irish Cancer SocietyReclutamentoDisagio psicologico | Recidiva del cancroIrlanda
-
University of BathNational Institute for Health Research, United Kingdom; Oxford Health NHS Foundation... e altri collaboratoriNon ancora reclutamentoRiduzione dello stress basato sull’empatia nel personale sanitario