Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:51 AM
Study NCT ID:
NCT07475494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Co-Designing Culturally Responsive Nursing Care in Primary Healthcare
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of the Culturally Responsive Nursing Care Intervention (Acceptability of Intervention Measure - AIM Score)', 'timeFrame': 'Immediately after completion of the intervention period (8 weeks).', 'description': '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.'}, {'measure': 'Feasibility of the Culturally Responsive Nursing Care Intervention (Feasibility of Intervention Measure - FIM Score)', 'timeFrame': 'Immediately after completion of the intervention period (8 weeks).', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Culturally Responsive Nursing', 'Cultural Competence', 'Cultural Safety', 'Person-Centered Care'], 'conditions': ['Culturally Responsive Care', 'Primary Health Care Providers', 'Patient-centered Care']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Harrison R,Newman B,Chauhan A,Holland K,Philibert C,Emerick J,Oataway K,Manias E,Wilson C'}, {'pmid': '32506136', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '39405106', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThe 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.\n\nFollowing 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nAdults aged 18 years or older.\n\nPatients receiving care in participating primary healthcare centres.\n\nAble to communicate in the language used for the study interviews and consultations.\n\nWilling and able to provide informed consent.\n\nPrimary healthcare nurses working in participating centres with at least one year of clinical experience in primary care.\n\nNurses willing to participate in training and implementation of the culturally responsive nursing care intervention.\n\nExclusion Criteria\n\nIndividuals unable to provide informed consent.\n\nPatients with severe cognitive impairment that would prevent participation in interviews or care planning discussions.\n\nPatients who are not receiving routine care within the participating primary healthcare centres.\n\nHealthcare professionals other than nurses involved in patient care.'}, 'identificationModule': {'nctId': 'NCT07475494', 'acronym': 'CRN-PHC', 'briefTitle': 'Co-Designing Culturally Responsive Nursing Care in Primary Healthcare', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Co-designing Culturally Responsive Nursing Care in Primary Healthcare: A Theory-Informed Double Diamond Intervention Development Study', 'orgStudyIdInfo': {'id': 'CRN-PHC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Culturally Responsive Nursing Care Intervention', 'description': "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.", 'interventionNames': ['Behavioral: Culturally Responsive Nursing Care Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Primary Healthcare Nursing Care', 'description': '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': [{'name': 'Culturally Responsive Nursing Care Intervention', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Culturally Responsive Nursing Care Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa sh kandil, phd', 'role': 'CONTACT', 'email': 'mostafa.shaban2020@cu.edu.eg', 'phone': '0223645336'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mostafa Shaban', 'investigatorAffiliation': 'Cairo University'}}}}