<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04505969</url>
  </required_header>
  <id_info>
    <org_study_id>NHREC/01/01/2007-23/03/2020</org_study_id>
    <nct_id>NCT04505969</nct_id>
  </id_info>
  <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</brief_title>
  <official_title>Pilot Study to Assess Patients' and Health Workers' Needs Involved in Sickle Cell Disease Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Barau Dikko Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot research is aimed to assess the needs of patients and health workers involved in&#xD;
      Sickle Cell Disease (SCD) management in Nigeria. To achieve this, a questionnaire will be&#xD;
      administered to SCD patients or parents of children affected by SCD. Another questionnaire&#xD;
      will be administered to doctors and nurses working with SCD patients. A focus group&#xD;
      discussion with patients/parents willing to participate will be also scheduled. Participants&#xD;
      from the following centres will be involved: Barau Dikko Teaching Hospital Kaduna State&#xD;
      University, Ahmadu Bello University Teaching Hospital Zaria, National Hospital Abuja, Federal&#xD;
      Medical Centre Katsina. Data will be qualitatively and quantitatively analysed and presented&#xD;
      as aggregated data. Consent from all the study participants will be sought. Questionnaires&#xD;
      will be coded and no personal data will be disclosed to authorised third parties.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to understand the needs of SCD patients and health&#xD;
      workers involved in SCD management, with particular reference to the disease management in&#xD;
      the clinical centre. This is a descriptive, mixed method prospective questionnaire-based&#xD;
      study.&#xD;
&#xD;
      The study is intended as a pilot experience to verify the feasibility of the action through a&#xD;
      structured survey.&#xD;
&#xD;
      Two questionnaires have been developed: one will be administered to 30 SCD patients or&#xD;
      parents/legally designated representatives of children affected by SCD and 30 Professionals&#xD;
      working with SCD patients (mainly doctors and nurses) in four clinical centres in Nigeria for&#xD;
      a total of 120 patients and 120 health workers. A focus group discussion will be run with the&#xD;
      SCD patients/parents. Following the pilot study, a wider survey will be launched involve&#xD;
      patients, parents and healthcare professionals in the whole country and in other centres&#xD;
      involved in the project.&#xD;
&#xD;
      Data for this study will be collected using triangulation methods. A simple random and&#xD;
      purposive sampling techniques will be used to select respondents for the study. The collected&#xD;
      data for this study will be presented and analysed using SPSS and thematic analysis. The&#xD;
      study will be conducted in four centres in Nigeria: Barau Dikko Teaching Hospital Kaduna&#xD;
      State University (BDTH), Ahmadu Bello University Teaching Hospital Zaria (ABUTH), National&#xD;
      Hospital Abuja (NHA), and Federal Medical Centre Katsina (FMC). The study will be performed&#xD;
      in the framework of the &quot;African Research and Innovative initiative for Sickle cell&#xD;
      Education: Improving Research Capacity for Service Improvement&quot; project (GA 824021 - ARISE -&#xD;
      H2020-MSCA-RISE-2018).&#xD;
&#xD;
      ARISE is the EU (Horizon 2020) 4-year funded project between European, African, US and&#xD;
      Lebanon institutions for research staff exchanges, started on 1st of January 2019. Fondazione&#xD;
      per la Ricerca Farmacologica Gianni Benzi Onlus coordinates the ARISE project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2020</start_date>
  <completion_date type="Actual">November 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction of patients and healthcare professionals in terms of Sickle Cell Disease management</measure>
    <time_frame>Single-point assessment, at the enrolment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">196</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>SCD patients and healthcare professionals</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire to assess needs</intervention_name>
    <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</description>
    <arm_group_label>SCD patients and healthcare professionals</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of Sickle Cell Disease or parents having a child with a diagnosis&#xD;
        of Sickle Cell Disease attending one of the clinical centres involved in the study.&#xD;
        Healthcare professionals, e.g. doctors, nurses, working with Sickle Cell Disease patients&#xD;
        in the clinical centres involved in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        The following inclusion criteria apply for patients/parents:&#xD;
&#xD;
          -  Aged ≥ 18&#xD;
&#xD;
          -  Have SCD diagnosis or having a child with a SCD diagnosis&#xD;
&#xD;
          -  Attending the centre from at least 6 months&#xD;
&#xD;
          -  Nigerian nationality&#xD;
&#xD;
          -  Informed Consent signed&#xD;
&#xD;
        The following inclusion criteria will apply for healthcare professionals:&#xD;
&#xD;
          -  Working in a SCD clinic&#xD;
&#xD;
          -  At least 5 years of experience with SCD patients&#xD;
&#xD;
          -  Informed Consent signed&#xD;
&#xD;
        The following exclusion criteria apply for all participants:&#xD;
&#xD;
          -  Informed consent form withdrawal&#xD;
&#xD;
          -  Illiterate subjects&#xD;
&#xD;
          -  Any psychiatric conditions impairing the participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>National Hospital Abuja</name>
      <address>
        <city>Abuja</city>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barau Dikko Teaching Hospital, Kaduna State University</name>
      <address>
        <city>Kaduna</city>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal Medical Centre Katsina</name>
      <address>
        <city>Katsina</city>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ahmadu Bello University Teaching Hospital Zaria</name>
      <address>
        <city>Zaria</city>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>25667774</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22099364</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25303249</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24114193</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27336011</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25365928</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26477868</PMID>
  </reference>
  <reference>
    <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</citation>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sickle Cell Disease</keyword>
  <keyword>healthcare professionals' needs</keyword>
  <keyword>patients'needs</keyword>
  <keyword>questionnaires</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be made available for verification at the time of study results publication in a peer-reviewed journal</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>September 20, 2022</submitted>
    <returned>August 11, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04505969
org study id: NHREC/01/01/2007-23/03/2020
nct id: NCT04505969
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Satisfaction of patients and healthcare professionals in terms of Sickle Cell Disease management
time frame: Single-point assessment, at the enrolment
description: 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.
arm group label: SCD patients and healthcare professionals
intervention type: Other
intervention name: Questionnaire to assess needs
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
arm group label: SCD patients and healthcare professionals
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
country: Nigeria
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: 25667774
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: 22099364
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: 25303249
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: 24114193
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: 27336011
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: 25365928
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.
PMID: 26477868
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
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell
sharing ipd: Yes
ipd 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.
ipd info type: Study Protocol
ipd time frame: Data will be made available for verification at the time of study results publication in a peer-reviewed journal
ipd 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.
submitted: September 20, 2022
returned: August 11, 2023