Co-Designing Culturally Responsive Nursing Care in Primary Healthcare (CRN-PHC)

March 11, 2026 updated by: Mostafa Shaban, Cairo University

Co-designing Culturally Responsive Nursing Care in Primary Healthcare: A Theory-Informed Double Diamond Intervention Development Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

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.

Exclusion Criteria

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Culturally Responsive Nursing Care Intervention
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
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.
No Intervention: Usual Primary Healthcare Nursing Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the Culturally Responsive Nursing Care Intervention (Acceptability of Intervention Measure - AIM Score)
Time Frame: Immediately after completion of the intervention period (8 weeks).
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)
Time Frame: Immediately after completion of the intervention period (8 weeks).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

April 18, 2026

Study Completion (Estimated)

April 20, 2026

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRN-PHC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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