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

February 8, 2022 updated by: Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Abuja, Nigeria
        • National Hospital Abuja
      • Kaduna, Nigeria
        • Barau Dikko Teaching Hospital, Kaduna State University
      • Katsina, Nigeria
        • Federal Medical Centre Katsina
      • Zaria, Nigeria
        • Ahmadu Bello University Teaching Hospital Zaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single-point assessment, at the enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

Collaborators

Barau Dikko Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 11, 2020

Primary Completion (ACTUAL)

November 11, 2020

Study Completion (ACTUAL)

November 11, 2020

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (ACTUAL)

August 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHREC/01/01/2007-23/03/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data will be made available for verification at the time of study results publication in a peer-reviewed journal

IPD Sharing 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 Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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