Culturally Responsive CareCRN-PHCNCT07475494
Co-Designing Culturally Responsive Nursing Care in Primary Healthcare
A study testing Culturally Responsive Nursing Care Intervention in people with Culturally Responsive Care and Primary Health Care Providers, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Culturally Responsive Care, Primary Health Care Providers, Patient-centered Care
- What is being tested?
- Culturally Responsive Nursing Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 20 Apr 2026
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
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: 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.
Read more
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.
- Being tested
- Culturally Responsive Nursing Care Intervention
- Keywords
- Culturally Responsive Nursing, Cultural Competence, Cultural Safety, Person-Centered Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Responsive Nursing Care InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after completion of the intervention period (8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion18 Apr 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Culturally Responsive CareStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475494
- Sponsor's protocol ID
- CRN-PHC-001
- Acronym
- CRN-PHC
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 41486562Sumner 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 32506136Sumner 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-designing Culturally Responsive Nursing Care in Primary Healthcare: A Theory-Informed Double Diamond Intervention Development Study
- ClinicalTrials.gov ID
- NCT07475494
- Acronym / sponsor ID
- CRN-PHC / CRN-PHC-001
- Keywords
- Culturally Responsive Nursing, Cultural Competence, Cultural Safety, Person-Centered Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 16 Mar 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Culturally Responsive Nursing Care Intervention | Experimental | Behavioral: Culturally Responsive Nursing Care InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Culturally Responsive Nursing Care InterventionThe 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. | Behavioural | Culturally Responsive Nursing Care Intervention |
Primary outcome
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.
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.
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 16 Mar 2026.
- Results publication: PubMed 41486562Harrison 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.
- Results publication: PubMed 32506136Sumner 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.
- Results publication: PubMed 39405106Sumner 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Responsive Nursing Care Intervention in people with Culturally Responsive Care and Primary Health Care Providers, run by Cairo University.
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 6 inclusion and 4 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 16 Mar 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 Mostafa sh kandil, phd (0223645336, mostafa.shaban2020@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07475494, which also lists 3 linked publications.
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 16 Mar 2026.