Health Adult SubjectsCOPS-ERANCT07911241
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
An observational study of Health Adult Subjects and Communication, run by Universidad Loyola Andalucia.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects, Communication, Clinical Communication
- What is being tested?
- ERA Scale (Healthcare Relationship Assessment Scale)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Sep 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
None listed.
Who cannot join
- Students not actively undertaking clinical placements during the study evaluation periods.
- Refusal to provide informed consent or withdrawal of consent at any point during data collection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of an Instrument for the Assessment of the Healthcare Relationship (ERA Scale) in Health Sciences Students During Clinical Placements
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.
Read the detailed description
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).
- Conditions
- Health Adult Subjects, Communication, Clinical Communication
- Being tested
- ERA Scale (Healthcare Relationship Assessment Scale)
- Keywords
- Psychometrics, Validation Study, Health Sciences Education, Soft Skills
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERA Scale (Healthcare Relationship Assessment Scale)Diagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Health Sciences Students | 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 Receives: Diagnostic Test: ERA Scale (Healthcare Relationship Assessment Scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the completion of each student's clinical placement period (approximately end of semester / academic year, up to 10 months).
Secondary outcomes (1)
Inter-Rater Reliability of the ERA Scale
Degree of agreement between clinical observers evaluated using the Intraclass Correlation Coefficient (ICC) or weighted Kappa coefficient.
Measured: Through the end of the academic evaluation cycle (up to 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad Loyola Andalucia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Deusto
- Responsible party
- Sponsor
- Investigators
- Raquel Ruiz-Íñiguez, PhD, Principal investigator, Universidad Loyola Andalucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911241
- Sponsor's protocol ID
- 260903 CE26897
- Acronym
- COPS-ERA
- Status last verified
- Nov 2026
- First submitted
- 26 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Instrument for the Assessment of the Healthcare Relationship (ERA Scale) in Health Sciences Students During Clinical Placements
- ClinicalTrials.gov ID
- NCT07911241
- Acronym / sponsor ID
- COPS-ERA / 260903 CE26897
- Conditions
- Health Adult Subjects, Communication, Clinical Communication
- Keywords
- Psychometrics, Validation Study, Health Sciences Education, Soft Skills
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidad Loyola AndaluciaUniversity, hospital or other
- Collaborators
- University of Deusto
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Sciences Students | – | Diagnostic Test: ERA Scale (Healthcare Relationship Assessment Scale)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Students not actively undertaking clinical placements during the study evaluation periods.
- Refusal to provide informed consent or withdrawal of consent at any point during data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Diagnostic test | Health Sciences Students |
Primary outcome
Construct Validity and Internal Structure of the ERA Scale
Time frame: At the completion of each student's clinical placement period (approximately end of semester / academic year, up to 10 months).
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
1 secondary outcome
Inter-Rater Reliability of the ERA Scale
Time frame: Through the end of the academic evaluation cycle (up to 12 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raquel Ruiz-Íñiguez, PhD principal investigator
Universidad Loyola Andalucia
Questions about this trial
What is this clinical trial studying?
An observational study of Health Adult Subjects and Communication, run by Universidad Loyola Andalucia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel Ruiz-Íñiguez, PhD (+34 955 641 600, rruiz@uloyola.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct Validity and Internal Structure of the ERA Scale (time frame: At the completion of each student's clinical placement period (approximately end of semester / academic year, up to 10 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.