CClinicalTrials.gg
Not yet recruitingNCT07475494CRN-PHCUpdated Mar 16, 2026

Co-Designing Culturally Responsive Nursing Care in Primary Healthcare

An interventional study of Culturally Responsive Nursing Care Intervention in Culturally Responsive Care, Primary Health Care Providers and Patient-centered Care, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Cairo University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Culturally Responsive Care
  • Primary Health Care Providers
  • Patient-centered Care

Keywords

  • Culturally Responsive Nursing
  • Cultural Competence
  • Cultural Safety
  • Person-Centered Care
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralCulturally 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Harrison R, Newman B, Chauhan A, Holland K, Philibert C, Emerick J, Oataway K, Manias E, Wilson C. Care My Way: Co-Designing a Patient-Held Resource to Improve Information Sharing Between Primary and Specialist Care for People With Cancer. Health Expect. 2026 Feb;29(1):e70498. doi: 10.1111/hex.70498. PubMed 41486562 ↗
  • 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. PubMed 32506136 ↗
  • 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. PubMed 39405106 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07475494
Lead sponsor
Cairo University
Responsible party
Mostafa Shaban (Principal Investigator, Cairo University) — Principal investigator
First posted
Mar 16, 2026
Start date
Mar 20, 2026 (estimated)
Primary completion
Apr 18, 2026 (estimated)
Completion
Apr 20, 2026 (estimated)
Last update
Mar 16, 2026

Study contacts

Mostafa sh kandil, phd
Contact
mostafa.shaban2020@cu.edu.eg
0223645336

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion