An observational study in Health Adult Subjects, Communication and Clinical Communication, sponsored by Universidad Loyola Andalucia. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Universidad Loyola Andalucia · Observational
This study aims to design and psychometrically validate a practical and agile observational instrument-the Healthcare Relationship Assessment scale (ERA scale)-to evaluate communication skills and person-centered care among undergraduate health sciences students (Nursing, Physiotherapy, Pharmacy, and Psychology) during their external clinical placements. Adapted from the theoretical framework of the CICAA scale, the instrument is designed to reduce evaluation burden for clinical mentors while maintaining high measurement reliability and validity.
erson-centered care requires healthcare professionals to master relational and communication competencies. Although clinical placements represent an ideal setting to train and assess these skills, existing tools like the CICAA scale present logistical challenges due to the extensive training and observation time required from clinical tutors. This sequential mixed-methods study comprises two phases: Qualitative phase: Semi-structured interviews with academic coordinators, clinical tutors, and recent graduates/students to refine item content, operational feasibility, and relevance based on the four CICAA dimensions (connecting, identifying/understanding health issues, agreeing on decisions/actions, and assisting in understanding and acting). Quantitative phase: A cross-sectional observational study where clinical tutors evaluate students at the end of their clinical placements using the ERA scale via Qualtrics. Psychometric evaluation will include Exploratory and Confirmatory Factor Analysis (CFI, TLI, RMSEA), internal consistency (Cronbach's alpha, McDonald's omega), inter-rater reliability, and response-process validity (paradata/response latencies).
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 300 is above the median of 104 across 132 observational studies indexed under Communication.
Browse Communication studies →Universidad Loyola Andalucia is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Undergraduate health sciences students from Nursing, Physiotherapy, Pharmacy, and Psychology degrees undergoing curricular external clinical placements across affiliated hospitals, primary healthcare centers, educational centers, and social health organizations, along with their assigned clinical tutors and academic practicum coordinators
Students (evaluated participants):
Clinical Tutors and Key Informants:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Undergraduate students enrolled in Nursing (years 1-4), Physiotherapy (years 3-4), Pharmacy (years 3-4), and Psychology (year 3) during their external clinical placements across affiliated health and social care centers. Their interpersonal communication and person-centered relational skills are evaluated observationally by their designated clinical tutors
Diagnostic Test: ERA Scale (Healthcare Relationship Assessment Scale)
An observational assessment tool adapted from the CICAA model to evaluate communication competencies and person-centered care in healthcare students during clinical practicum. The instrument is completed online via Qualtrics by clinical tutors once at the end of the student's clinical placement period (taking approximately 10 minutes).
Construct Validity and Internal Structure of the ERA Scale
Goodness-of-fit indices evaluated via Exploratory and Confirmatory Factor Analysis (CFI ≥ 0.95, TLI ≥ 0.95, RMSEA ≤ 0.06) based on tutor ratings of student communication and relationship skills
Time frame: At the completion of each student's clinical placement period (approximately end of semester / academic year, up to 10 months).
Inter-Rater Reliability of the ERA Scale
Degree of agreement between clinical observers evaluated using the Intraclass Correlation Coefficient (ICC) or weighted Kappa coefficient.
Time frame: Through the end of the academic evaluation cycle (up to 12 months).
No study locations are listed for this record.
Plan to share: No — In accordance with the study protocol approved by the institutional ethics committee and the participant informed consent agreements, raw individual participant data will remain strictly confidential and will not be shared with outside parties or third-party researchers. Study results will be disseminated exclusively as aggregated data
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Universidad Loyola Andalucia