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
Pilot Study to Assess Patients' and Health Workers' Needs Involved in Sickle Cell Disease Management
1 other identifier
observational
192
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2020
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedStudy Start
First participant enrolled
August 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2020
CompletedResults Posted
Study results publicly available
May 10, 2024
CompletedMay 10, 2024
November 1, 2023
3 months
August 6, 2020
September 20, 2022
November 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Level of Satisfaction on SCD Current Treatment and Management
Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.
Single-point assessment, at the enrolment
Rating of the Overall Service Quality
Likert scale from 1 (very poor) to 5 (very good). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.
Single-point assessment, at the enrolment
Level of Satisfaction About Nursing Care in Clinic
Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.
Single-point, at the enrollment
Rating of the Facilities to Manage SCD Patients
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
Single-point assessment, at the enrolment
Level of Satisfaction on Responsibility
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.
Single-point assessment, at the enrolment
Level of Global Satisfaction on the Work With SCD Patients
Likert scale from 1 (very dissatisfied) to 5 (very satisfied)
Single-point assessment, at the enrolment
Secondary Outcomes (14)
Level of Appreciation of the Work
Single-point assessment, at the enrolment
Level of Satisfaction on Protection From Injuries and Professional Risks
Single-point assessment, at the enrolment
Level of Satisfaction on the Management of the Clinic
Single-point assessment, at the enrolment
Level of Satisfaction on the Instruction Given by Doctor About Pain Control
Single-point assessment, at the enrollment
Level of Satisfaction on the Support Received at the Time of the Diagnosis
Single-point assessment, at the enrolment
- +9 more secondary outcomes
Study Arms (2)
SCD patients
Healthcare professionals
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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
- Working in a SCD clinic
- At least 5 years of experience with SCD patients
- Informed Consent signed
You may not qualify if:
- Informed consent form withdrawal
- Illiterate subjects
- Any psychiatric conditions impairing the participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
National Hospital Abuja
Abuja, Nigeria
Barau Dikko Teaching Hospital, Kaduna State University
Kaduna, Nigeria
Federal Medical Centre Katsina
Katsina, Nigeria
Ahmadu Bello University Teaching Hospital Zaria
Zaria, Nigeria
Related Publications (8)
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: 25667774BACKGROUNDGrosse 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: 22099364BACKGROUNDKing 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: 25303249BACKGROUNDGaladanci 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: 24114193BACKGROUNDGreen 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: 27336011BACKGROUNDMakani 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: 25365928BACKGROUNDMcGann 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: 26477868BACKGROUNDWorld 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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Study Principal investigator
- Organization
- Barau Dikko Teaching Hospital, Kaduna State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2020
First Posted
August 10, 2020
Study Start
August 11, 2020
Primary Completion
November 11, 2020
Study Completion
November 11, 2020
Last Updated
May 10, 2024
Results First Posted
May 10, 2024
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- 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.
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.