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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

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ClinicalTrials.gov Identifier: NCT04505969
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Barau Dikko Teaching Hospital
Information provided by (Responsible Party):
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

Brief Summary:
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.

Condition or disease Intervention/treatment
Sickle Cell Disease Other: Questionnaire to assess needs

Detailed Description:

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.

The study is intended as a pilot experience to verify the feasibility of the action through a structured survey.

Two 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.

Data 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).

ARISE 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.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pilot Study to Assess Patients' and Health Workers' Needs Involved in Sickle Cell Disease Management
Actual Study Start Date : September 15, 2020
Actual Primary Completion Date : November 9, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SCD patients and healthcare professionals Other: Questionnaire to assess needs
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




Primary Outcome Measures :
  1. Satisfaction of patients and healthcare professionals in terms of Sickle Cell Disease management [ Time Frame: Single-point assessment, at the enrolment ]
    The % of interviewed patients and healthcare professionals judging as satisfactory the SCD management in their centre. This will be measured through a questionnaire developed in the framework of the ARISE project and tailored on Nigerian framework.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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.
Criteria

The following inclusion criteria apply for patients/parents:

  • Aged ≥ 18
  • Have SCD diagnosis or having a child with a SCD diagnosis
  • Attending the centre from at least 6 months
  • Nigerian nationality
  • Informed Consent signed

The following inclusion criteria will apply for healthcare professionals:

  • Working in a SCD clinic
  • At least 5 years of experience with SCD patients
  • Informed Consent signed

The following exclusion criteria apply for all participants:

  • Informed consent form withdrawal
  • Illiterate subjects
  • Any psychiatric conditions impairing the participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505969


Contacts
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Contact: Abubakar Abdulkareem, MSc +2348066664042 abubakarabdulkareem8@gmail.com

Locations
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Nigeria
National Hospital Abuja Not yet recruiting
Abuja, Nigeria
Contact: Halima Aliyu         
Barau Dikko Teaching Hospital, Kaduna State University Not yet recruiting
Kaduna, Nigeria
Contact: Abubakar Abdulkareem         
Federal Medical Centre Katsina Recruiting
Katsina, Nigeria
Contact: Halima Aliyu         
Ahmadu Bello University Teaching Hospital Zaria Recruiting
Zaria, Nigeria
Contact: Aliyu Mande         
Sponsors and Collaborators
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Barau Dikko Teaching Hospital
Publications:
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

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Responsible Party: Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
ClinicalTrials.gov Identifier: NCT04505969    
Other Study ID Numbers: NHREC/01/01/2007-23/03/2020
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Time Frame: Data will be made available for verification at the time of study results publication in a peer-reviewed journal
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus:
Sickle Cell Disease
healthcare professionals' needs
patients'needs
questionnaires
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn