Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT04505969
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2020-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Aimed to Assess the Needs of Subjects With Sickle Cell Disease and Healthcare Professionals Managing Sickle Cell Disease Patients in Selected Nigerian Centres
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abubakarabdulkareem8@gmail.com', 'phone': '+2348066664042', 'title': 'Study Principal investigator', 'organization': 'Barau Dikko Teaching Hospital, Kaduna State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Challenges due to the COVID-19 pandemics impacted on the conduction of the study. Recruitment target was lower than expectations, timelines were extended and the protocol was amended.'}}, 'adverseEventsModule': {'description': 'Information not collected, not applicable', 'eventGroups': [{'id': 'EG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working in a SCD clinic having at least 5 years of experience with SCD patients', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Level of Satisfaction on SCD Current Treatment and Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '0.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents.'}, {'type': 'PRIMARY', 'title': 'Rating of the Overall Service Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.37', 'spread': '0.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very poor) to 5 (very good). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents.'}, {'type': 'PRIMARY', 'title': 'Level of Satisfaction About Nursing Care in Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.22', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point, at the enrollment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents.'}, {'type': 'PRIMARY', 'title': 'Rating of the Facilities to Manage SCD Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '0.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very poor) to 5 (very good). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'type': 'PRIMARY', 'title': 'Level of Satisfaction on Responsibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.22', 'spread': '0.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Healthcare professionals have been asked to indicate their satisfaction about their responsibility in the clinic, using a Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'type': 'PRIMARY', 'title': 'Level of Global Satisfaction on the Work With SCD Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.17', 'spread': '0.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Level of Appreciation of the Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.25', 'spread': '0.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on Protection From Injuries and Professional Risks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'spread': '0.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on the Management of the Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.17', 'spread': '0.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on the Instruction Given by Doctor About Pain Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.33', 'spread': '0.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrollment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients or parents of children with SCD', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SCD patients or parents of children with SCD'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on the Support Received at the Time of the Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.33', 'spread': '0.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on the Involvement by Doctors in Decisions That Affect the Course of Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.35', 'spread': '0.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrollment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on the Services Provided in the Lab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '0.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on the Communication About Sickle Cell Disease and Its Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.25', 'spread': '0.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction in Communicating With Lab Technicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.07', 'spread': '0.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction in Communicating With Nurses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SCD Patients', 'description': 'SCD patients or parents of children with SCD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.19', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrollment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on the Relationship You Have With the Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.49', 'spread': '0.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on Involvement in the Decision-making Process of Your Centre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.06', 'spread': '0.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on Professional Career Advancement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '0.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}, {'type': 'SECONDARY', 'title': 'Level of Satisfaction on the Decision-making Autonomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Professionals', 'description': 'Healthcare professionals working with SCD patients'}], 'classes': [{'categories': [{'measurements': [{'value': '4.11', 'spread': '0.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SCD Patients or Parents of Children With SCD', 'description': 'SCD patients or parents/legally designated representatives of children with SCD attending the selected facilities'}, {'id': 'FG001', 'title': 'Healthcare Professionals Working in a SCD Clinic', 'description': 'Healthcare professionals working in a SCD clinic having at least 5 years of experience with SCD patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'After obtaining the informed consent, SCD patients, parents/legally designated representatives have been asked to complete a questionnaire.\n\nThe investigator gave instructions to complete, but questionnaires were self-completed.\n\nParticipants had time to complete the questionnaire in a private setting and returned completed questionnaires in a closed box, that was safeguarded by the investigators.', 'groupId': 'FG000', 'numSubjects': '108'}, {'comment': 'After obtaining the informed consent, healthcare professionals were asked to complete a questionnaire.The investigator gave instructions, but questionnaires were self-completed.\n\nParticipants had time to complete the questionnaire in a private setting and returned completed questionnaires in a closed box, that was safeguarded by the investigators.\n\nParticipants received information about the time and venue for a 45-60 minutes focus group discussion, led by the study principal investigator.', 'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '4 four clinical centres in Kaduna and Katsina state, Nigeria were involved in the enrollement: Barau Dikko Teaching Hospital Kaduna State University (BDTH), Ahmadu Bello University Teaching Hospital Zaria (ABUTH), National Hospital Abuja (NHA), Federal Medical Centre Katsina (FMC). Centres were selected to be easily accessible to the principal investigator and his collaborators.\n\nA random and purposive sampling technique was adopted. Recruitment started in August 2020 and ended in October 2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SCD Patients or Parents of Children With SCD', 'description': 'SCD patients or parents/legally designated representatives of children with SCD attending the selected facilities'}, {'id': 'BG001', 'title': 'Healthcare Professionals Working in a SCD Clinic', 'description': 'Healthcare professionals working in a SCD clinic having at least 5 years of experience with SCD patients'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'unknown', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Nigeria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-03-04', 'size': 449799, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-20T10:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2020-08-06', 'resultsFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-23', 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Satisfaction on SCD Current Treatment and Management', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.'}, {'measure': 'Rating of the Overall Service Quality', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very poor) to 5 (very good). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.'}, {'measure': 'Level of Satisfaction About Nursing Care in Clinic', 'timeFrame': 'Single-point, at the enrollment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.'}, {'measure': 'Rating of the Facilities to Manage SCD Patients', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very poor) to 5 (very good). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'measure': 'Level of Satisfaction on Responsibility', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Healthcare professionals have been asked to indicate their satisfaction about their responsibility in the clinic, using a Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}, {'measure': 'Level of Global Satisfaction on the Work With SCD Patients', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied)'}], 'secondaryOutcomes': [{'measure': 'Level of Appreciation of the Work', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'measure': 'Level of Satisfaction on Protection From Injuries and Professional Risks', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'measure': 'Level of Satisfaction on the Management of the Clinic', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients'}, {'measure': 'Level of Satisfaction on the Instruction Given by Doctor About Pain Control', 'timeFrame': 'Single-point assessment, at the enrollment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients or parents of children with SCD'}, {'measure': 'Level of Satisfaction on the Support Received at the Time of the Diagnosis', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'measure': 'Level of Satisfaction on the Involvement by Doctors in Decisions That Affect the Course of Disease', 'timeFrame': 'Single-point assessment, at the enrollment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.'}, {'measure': 'Level of Satisfaction on the Services Provided in the Lab', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'measure': 'Level of Satisfaction on the Communication About Sickle Cell Disease and Its Treatment', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'measure': 'Level of Satisfaction in Communicating With Lab Technicians', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.'}, {'measure': 'Level of Satisfaction in Communicating With Nurses', 'timeFrame': 'Single-point assessment, at the enrollment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents'}, {'measure': 'Level of Satisfaction on the Relationship You Have With the Patients', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}, {'measure': 'Level of Satisfaction on Involvement in the Decision-making Process of Your Centre', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}, {'measure': 'Level of Satisfaction on Professional Career Advancement', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}, {'measure': 'Level of Satisfaction on the Decision-making Autonomy', 'timeFrame': 'Single-point assessment, at the enrolment', 'description': 'Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle Cell Disease', "healthcare professionals' needs", "patients'needs", 'questionnaires'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '25667774', 'type': 'BACKGROUND', 'citation': 'Adewoyin AS. Management of sickle cell disease: a review for physician education in Nigeria (sub-saharan Africa). Anemia. 2015;2015:791498. doi: 10.1155/2015/791498. Epub 2015 Jan 18.'}, {'pmid': '22099364', 'type': 'BACKGROUND', 'citation': 'Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, Williams TN. Sickle cell disease in Africa: a neglected cause of early childhood mortality. Am J Prev Med. 2011 Dec;41(6 Suppl 4):S398-405. doi: 10.1016/j.amepre.2011.09.013.'}, {'pmid': '25303249', 'type': 'BACKGROUND', 'citation': 'King L, Knight-Madden J, Reid M. Newborn screening for sickle cell disease in Jamaica: a review - past, present and future. West Indian Med J. 2014 Mar;63(2):147-50. doi: 10.7727/wimj.2013.107. Epub 2014 Apr 11.'}, {'pmid': '24114193', 'type': 'BACKGROUND', 'citation': 'Galadanci N, Wudil BJ, Balogun TM, Ogunrinde GO, Akinsulie A, Hasan-Hanga F, Mohammed AS, Kehinde MO, Olaniyi JA, Diaku-Akinwumi IN, Brown BJ, Adeleke S, Nnodu OE, Emodi I, Ahmed S, Osegbue AO, Akinola N, Opara HI, Adegoke SA, Aneke J, Adekile AD. Current sickle cell disease management practices in Nigeria. Int Health. 2014 Mar;6(1):23-8. doi: 10.1093/inthealth/iht022. Epub 2013 Oct 10.'}, {'pmid': '27336011', 'type': 'BACKGROUND', 'citation': 'Green NS, Mathur S, Kiguli S, Makani J, Fashakin V, LaRussa P, Lyimo M, Abrams EJ, Mulumba L, Mupere E. Family, Community, and Health System Considerations for Reducing the Burden of Pediatric Sickle Cell Disease in Uganda Through Newborn Screening. Glob Pediatr Health. 2016 Apr 7;3:2333794X16637767. doi: 10.1177/2333794X16637767. eCollection 2016.'}, {'pmid': '25365928', 'type': 'BACKGROUND', 'citation': 'Makani J, Soka D, Rwezaula S, Krag M, Mghamba J, Ramaiya K, Cox SE, Grosse SD. Health policy for sickle cell disease in Africa: experience from Tanzania on interventions to reduce under-five mortality. Trop Med Int Health. 2015 Feb;20(2):184-7. doi: 10.1111/tmi.12428. Epub 2014 Nov 17.'}, {'pmid': '26477868', 'type': 'BACKGROUND', 'citation': 'McGann PT, Grosse SD, Santos B, de Oliveira V, Bernardino L, Kassebaum NJ, Ware RE, Airewele GE. A Cost-Effectiveness Analysis of a Pilot Neonatal Screening Program for Sickle Cell Anemia in the Republic of Angola. J Pediatr. 2015 Dec;167(6):1314-9. doi: 10.1016/j.jpeds.2015.08.068. Epub 2015 Oct 23.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization. Sickle-Cell Anaemia Report by the Secretariat. Fifty-Ninth World Health Assembly, c2006. Available from: http://www. apps.who.int/gb/ebwha/pdf_files/WHA59/A59_9-en.pdf'}]}, 'descriptionModule': {'briefSummary': 'This pilot research is aimed to assess the needs of patients and health workers involved in Sickle Cell Disease (SCD) management in Nigeria. To achieve this, a questionnaire will be administered to SCD patients or parents of children affected by SCD. Another questionnaire will be administered to doctors and nurses working with SCD patients. A focus group discussion with patients/parents willing to participate will be also scheduled. Participants from the following centres will be involved: Barau Dikko Teaching Hospital Kaduna State University, Ahmadu Bello University Teaching Hospital Zaria, National Hospital Abuja, Federal Medical Centre Katsina. Data will be qualitatively and quantitatively analysed and presented as aggregated data. Consent from all the study participants will be sought. Questionnaires will be coded and no personal data will be disclosed to authorised third parties.', 'detailedDescription': 'The primary objective of this study is to understand the needs of SCD patients and health workers involved in SCD management, with particular reference to the disease management in the clinical centre. This is a descriptive, mixed method prospective questionnaire-based study.\n\nThe study is intended as a pilot experience to verify the feasibility of the action through a structured survey.\n\nTwo questionnaires have been developed: one will be administered to 30 SCD patients or parents/legally designated representatives of children affected by SCD and 30 Professionals working with SCD patients (mainly doctors and nurses) in four clinical centres in Nigeria for a total of 120 patients and 120 health workers. A focus group discussion will be run with the SCD patients/parents. Following the pilot study, a wider survey will be launched involve patients, parents and healthcare professionals in the whole country and in other centres involved in the project.\n\nData for this study will be collected using triangulation methods. A simple random and purposive sampling techniques will be used to select respondents for the study. The collected data for this study will be presented and analysed using SPSS and thematic analysis. The study will be conducted in four centres in Nigeria: Barau Dikko Teaching Hospital Kaduna State University (BDTH), Ahmadu Bello University Teaching Hospital Zaria (ABUTH), National Hospital Abuja (NHA), and Federal Medical Centre Katsina (FMC). The study will be performed in the framework of the "African Research and Innovative initiative for Sickle cell Education: Improving Research Capacity for Service Improvement" project (GA 824021 - ARISE - H2020-MSCA-RISE-2018).\n\nARISE is the EU (Horizon 2020) 4-year funded project between European, African, US and Lebanon institutions for research staff exchanges, started on 1st of January 2019. Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus coordinates the ARISE project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of Sickle Cell Disease or parents having a child with a diagnosis of Sickle Cell Disease attending one of the clinical centres involved in the study. Healthcare professionals, e.g. doctors, nurses, working with Sickle Cell Disease patients in the clinical centres involved in the study.', 'eligibilityCriteria': 'The following inclusion criteria apply for patients/parents:\n\n* Aged ≥ 18\n* Have SCD diagnosis or having a child with a SCD diagnosis\n* Attending the centre from at least 6 months\n* Nigerian nationality\n* Informed Consent signed\n\nThe following inclusion criteria will apply for healthcare professionals:\n\n* Working in a SCD clinic\n* At least 5 years of experience with SCD patients\n* Informed Consent signed\n\nThe following exclusion criteria apply for all participants:\n\n* Informed consent form withdrawal\n* Illiterate subjects\n* Any psychiatric conditions impairing the participation in this study.'}, 'identificationModule': {'nctId': 'NCT04505969', 'briefTitle': 'A Study Aimed to Assess the Needs of Subjects With Sickle Cell Disease and Healthcare Professionals Managing Sickle Cell Disease Patients in Selected Nigerian Centres', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus'}, 'officialTitle': "Pilot Study to Assess Patients' and Health Workers' Needs Involved in Sickle Cell Disease Management", 'orgStudyIdInfo': {'id': 'NHREC/01/01/2007-23/03/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SCD patients', 'interventionNames': ['Other: Questionnaire to assess needs']}, {'label': 'Healthcare professionals', 'interventionNames': ['Other: Questionnaire to assess needs']}], 'interventions': [{'name': 'Questionnaire to assess needs', 'type': 'OTHER', 'description': 'Two questionnaires have been developed to assess the specific needs of healthcare professionals working with SCD patients and of SCD patients or parents of children with SCD', 'armGroupLabels': ['Healthcare professionals', 'SCD patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abuja', 'country': 'Nigeria', 'facility': 'National Hospital Abuja', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}, {'city': 'Kaduna', 'country': 'Nigeria', 'facility': 'Barau Dikko Teaching Hospital, Kaduna State University', 'geoPoint': {'lat': 10.52641, 'lon': 7.43879}}, {'city': 'Katsina', 'country': 'Nigeria', 'facility': 'Federal Medical Centre Katsina', 'geoPoint': {'lat': 12.99082, 'lon': 7.60177}}, {'city': 'Zaria', 'country': 'Nigeria', 'facility': 'Ahmadu Bello University Teaching Hospital Zaria', 'geoPoint': {'lat': 11.11128, 'lon': 7.7227}}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be made available for verification at the time of study results publication in a peer-reviewed journal', 'ipdSharing': 'YES', 'description': 'The research data needed to validate the results presented in the published scientific papers will be made available for verification and re-use, unless there will arise justified reasons for keeping specific datasets confidential. This will be done in compliance with the obligation to protect results, the confidentiality obligations, the security obligations, and the obligations to protect personal data as set out in the ARISE Partnership Agreement and in the Study Protocol. All the data will be anonymised before publishing.', 'accessCriteria': 'A controlled access to research data will be sought. A data access form will be made available, asking for: the purpose for data request, applicant information, brief description of the research project, description of requested data, any plan for publishing results. According to the type of data, the terms for sharing will be evaluated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Barau Dikko Teaching Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}