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

Sickle Cell Disease Clinical Trial

Official title:

Pilot Study to Assess Patients' and Health Workers' Needs Involved in Sickle Cell Disease Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505969
• Other study ID #: NHREC/01/01/2007-23/03/2020
• Status: Completed
• Start date: August 11, 2020
• Est. completion date: November 11, 2020

Study information

• Verified date: November 2023
• Source: Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
Nigeria	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

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus	Barau Dikko Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Level of Appreciation of the Work	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
Secondary	Level of Satisfaction on Protection From Injuries and Professional Risks	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
Secondary	Level of Satisfaction on the Management of the Clinic	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
Secondary	Level of Satisfaction on the Instruction Given by Doctor About Pain Control	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	Single-point assessment, at the enrollment
Secondary	Level of Satisfaction on the Support Received at the Time of the Diagnosis	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
Secondary	Level of Satisfaction on the Involvement by Doctors in Decisions That Affect the Course of Disease	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 enrollment
Secondary	Level of Satisfaction on the Services Provided in the Lab	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
Secondary	Level of Satisfaction on the Communication About Sickle Cell Disease and Its Treatment	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
Secondary	Level of Satisfaction in Communicating With Lab Technicians	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
Secondary	Level of Satisfaction in Communicating With Nurses	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 enrollment
Secondary	Level of Satisfaction on the Relationship You Have With the Patients	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
Secondary	Level of Satisfaction on Involvement in the Decision-making Process of Your Centre	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
Secondary	Level of Satisfaction on Professional Career Advancement	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
Secondary	Level of Satisfaction on the Decision-making Autonomy	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