Clinical trial NCT04505969: 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
Official title: Pilot Study to Assess Patients' and Health Workers' Needs Involved in Sickle Cell Disease Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
healthcare professionals' needs
patients'needs
questionnaires
Lead sponsor: Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Sponsor class: OTHER
Collaborators: name: Barau Dikko Teaching Hospital
First posted: 2020-08-10
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Level of Satisfaction on SCD Current Treatment and Management
timeFrame: Single-point assessment, at the enrolment
measure: Rating of the Overall Service Quality
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction About Nursing Care in Clinic
timeFrame: Single-point, at the enrollment
measure: Rating of the Facilities to Manage SCD Patients
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on Responsibility
timeFrame: Single-point assessment, at the enrolment
measure: Level of Global Satisfaction on the Work With SCD Patients
timeFrame: Single-point assessment, at the enrolment
Secondary outcomes:
measure: Level of Appreciation of the Work
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on Protection From Injuries and Professional Risks
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on the Management of the Clinic
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on the Instruction Given by Doctor About Pain Control
timeFrame: Single-point assessment, at the enrollment
measure: Level of Satisfaction on the Support Received at the Time of the Diagnosis
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on the Involvement by Doctors in Decisions That Affect the Course of Disease
timeFrame: Single-point assessment, at the enrollment
measure: Level of Satisfaction on the Services Provided in the Lab
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on the Communication About Sickle Cell Disease and Its Treatment
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction in Communicating With Lab Technicians
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction in Communicating With Nurses
timeFrame: Single-point assessment, at the enrollment
measure: Level of Satisfaction on the Relationship You Have With the Patients
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on Involvement in the Decision-making Process of Your Centre
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on Professional Career Advancement
timeFrame: Single-point assessment, at the enrolment
measure: Level of Satisfaction on the Decision-making Autonomy
timeFrame: Single-point assessment, at the enrolment
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: National Hospital Abuja
city: Kaduna
country: Nigeria
facility: Barau Dikko Teaching Hospital, Kaduna State University
city: Katsina
country: Nigeria
facility: Federal Medical Centre Katsina
city: Zaria
country: Nigeria
facility: Ahmadu Bello University Teaching Hospital Zaria
Study officials:
References:
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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: 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: 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