NCT06944678

Brief Summary

Increasing globalisation and international migration have led to greater cultural diversity in Western societies, including healthcare settings. Hospitals and healthcare environments have become meeting places for individuals from different cultural backgrounds. This diversity presents significant opportunities for improving healthcare, but also introduces complex challenges related to communication, trust and mutual understanding between healthcare professionals and patients. In this context, the concept of culturally competent care, i.e. the ability of healthcare professionals to provide respectful and appropriate care to patients by taking into account their cultural beliefs, values and practices, emerges as a crucial approach to address the specific needs of patients from different cultures. The concept of cultural competence was first introduced by Cross, who defines it as a set of behaviours, attitudes and policies that, when integrated into an organisation or among professionals, enable them to operate effectively in intercultural contexts.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Apr 2025May 2027

First Submitted

Initial submission to the registry

April 4, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

April 4, 2025

Last Update Submit

August 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Health workers' perceived utility of the cultural concordance system

    Assessed through thematic content analysis of semi-structured interviews.

    12 months

  • Socio-demographic characteristics of health workers

    Collected using a socio-demographic questionnaire.

    12 months

Secondary Outcomes (5)

  • Patients' perceptions of the cultural sensitivity of care received

    24 months

  • Socio-demographic characteristics of patients

    24 months

  • Barriers to implementation of the cultural concordance system

    24 months

  • Facilitators to implementation of the cultural concordance system

    24 months

  • Development of evidence-based recommendations to improve cultural concordance

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted by enrolling participants who adopt a cultural concordance system.

You may qualify if:

  • All nurses or caregivers involved in the concordance system cultural will be included, with direct experience in caring for foreign patients
  • All foreign patients admitted to hospital who speak a language other than the main language of the host country and who have been involved in the concordance system cultural will be included

You may not qualify if:

  • All patients with severe cognitive conditions that prevent participation and nurses or caregivers who do not work closely with assigned patients will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Study Officials

  • Cristina Pistacchio, PI

    Fondazione Policlinico A. Gemelli IRCCS, Rome

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 25, 2025

Study Start

April 10, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations