NCT07475494

Brief Summary

Primary healthcare nurses frequently care for patients from diverse cultural backgrounds. Cultural beliefs and expectations about illness, treatment, and communication can influence how patients understand health information and participate in care decisions. When these cultural perspectives are not adequately recognized during clinical encounters, misunderstandings may occur, potentially affecting patient engagement, trust in healthcare providers, and adherence to care plans. This study aims to develop and pilot test a culturally responsive nursing care intervention designed for use in primary healthcare settings. The intervention focuses on improving communication between nurses and patients by supporting nurses in exploring patients' cultural perspectives, health priorities, and personal experiences of illness during routine consultations. The goal is to promote shared understanding and collaborative care planning. The intervention will be developed using a participatory co-design process involving patients, family caregivers, and primary healthcare nurses. Participants will share their experiences and contribute ideas for improving culturally responsive care. These insights will be used to create a structured nursing care approach that can be integrated into routine primary healthcare consultations. Following development, the intervention will be pilot tested with a small group of nurses and patients in primary healthcare centres. The pilot phase will assess whether the intervention is feasible to implement in routine practice and acceptable to both patients and nurses. Participants will provide feedback on their experiences with the intervention through surveys and interviews. The findings from this study will inform the development of culturally responsive nursing practices that support improved communication, patient engagement, and personalised care in primary healthcare settings.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

29 days

First QC Date

March 8, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Culturally Responsive NursingCultural CompetenceCultural SafetyPerson-Centered Care

Outcome Measures

Primary Outcomes (2)

  • Acceptability of the Culturally Responsive Nursing Care Intervention (Acceptability of Intervention Measure - AIM Score)

    Acceptability of the intervention will be measured using the Acceptability of Intervention Measure (AIM), a validated four-item implementation outcome scale. Each item is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater perceived acceptability of the intervention among participants.

    Immediately after completion of the intervention period (8 weeks).

  • Feasibility of the Culturally Responsive Nursing Care Intervention (Feasibility of Intervention Measure - FIM Score)

    Feasibility will be assessed using the Feasibility of Intervention Measure (FIM), a validated four-item implementation outcome scale. Each item is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater perceived feasibility of implementing the intervention in routine primary healthcare practice.

    Immediately after completion of the intervention period (8 weeks).

Study Arms (2)

Culturally Responsive Nursing Care Intervention

EXPERIMENTAL

Participants in this arm will receive a culturally responsive nursing care intervention delivered by trained primary healthcare nurses during routine consultations. The intervention focuses on structured nurse-patient conversations that explore patients' cultural perspectives, illness experiences, personal health priorities, and social contexts. Nurses will use a guided conversation framework to support shared understanding and collaborative care planning. The intervention will be implemented over a series of routine primary healthcare consultations and aims to improve communication, patient engagement, and culturally responsive care delivery.

Behavioral: Culturally Responsive Nursing Care Intervention

Usual Primary Healthcare Nursing Care

NO INTERVENTION

Participants in this arm will receive usual nursing care provided in routine primary healthcare consultations. Usual care may include health assessment, patient education, chronic disease monitoring, and care coordination according to existing clinical practices within the healthcare centre. No structured culturally responsive communication framework will be used.

Interventions

The culturally responsive nursing care intervention is a structured approach designed to support nurses in integrating patients' cultural perspectives and personal health priorities into routine care conversations. Nurses participating in the intervention will receive training on culturally responsive communication and patient-centred care principles. During consultations, nurses will use guided conversational prompts to explore patients' illness experiences, cultural beliefs influencing health behaviours, and individual care priorities. This information will be used to collaboratively develop personalised care plans aligned with both clinical recommendations and patients' cultural and social contexts.

Culturally Responsive Nursing Care Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older.
  • Patients receiving care in participating primary healthcare centres.
  • Able to communicate in the language used for the study interviews and consultations.
  • Willing and able to provide informed consent.
  • Primary healthcare nurses working in participating centres with at least one year of clinical experience in primary care.
  • Nurses willing to participate in training and implementation of the culturally responsive nursing care intervention.

You may not qualify if:

  • Individuals unable to provide informed consent.
  • Patients with severe cognitive impairment that would prevent participation in interviews or care planning discussions.
  • Patients who are not receiving routine care within the participating primary healthcare centres.
  • Healthcare professionals other than nurses involved in patient care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Harrison R,Newman B,Chauhan A,Holland K,Philibert C,Emerick J,Oataway K,Manias E,Wilson C

    RESULT
  • Sumner J, Chong LS, Bundele A, Wei Lim Y. Co-Designing Technology for Aging in Place: A Systematic Review. Gerontologist. 2021 Sep 13;61(7):e395-e409. doi: 10.1093/geront/gnaa064.

  • Sumner J, Tan SY, Wang Y, Keck CHS, Xin Lee EW, Chew EHH, Yip AW. Co-Designing Remote Patient Monitoring Technologies for Inpatients: Systematic Review. J Med Internet Res. 2024 Oct 15;26:e58144. doi: 10.2196/58144.

Central Study Contacts

Mostafa sh kandil, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking is not applied in this study due to the nature of the intervention, which involves direct interaction between nurses and patients during routine primary healthcare consultations. Both participants and care providers are aware of the intervention being delivered.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be assigned to one of two parallel groups: an intervention group receiving culturally responsive nursing care delivered by trained primary healthcare nurses and a control group receiving usual nursing care. The intervention focuses on structured nurse-patient conversations that explore cultural perspectives, personal illness experiences, and individual care priorities to support collaborative care planning. The study will evaluate the feasibility and acceptability of implementing the intervention in routine primary healthcare consultations.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 16, 2026

Study Start

March 20, 2026

Primary Completion

April 18, 2026

Study Completion

April 20, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share