Sickle Cell Disease
Conditions
Keywords
Sickle Cell Disease, healthcare professionals' needs, patients'needs, questionnaires
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.
Interventions
OTHERQuestionnaire 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
Sponsors
Barau Dikko Teaching Hospital
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Satisfaction on SCD Current Treatment and Management | Single-point assessment, at the enrolment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents. |
| Rating of the Overall Service Quality | Single-point assessment, at the enrolment | Likert scale from 1 (very poor) to 5 (very good). This Outcome Measure was pre-specified to be measured in only SCD patients/parents. |
| Level of Satisfaction About Nursing Care in Clinic | Single-point, at the enrollment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents. |
| Rating of the Facilities to Manage SCD Patients | Single-point assessment, at the enrolment | 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 |
| Level of Satisfaction on Responsibility | Single-point assessment, at the enrolment | 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. |
| Level of Global Satisfaction on the Work With SCD Patients | Single-point assessment, at the enrolment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Satisfaction on the Services Provided in the Lab | Single-point assessment, at the enrolment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents |
| Level of Satisfaction on the Communication About Sickle Cell Disease and Its Treatment | Single-point assessment, at the enrolment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents |
| Level of Satisfaction in Communicating With Lab Technicians | Single-point assessment, at the enrolment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents. |
| Level of Satisfaction in Communicating With Nurses | Single-point assessment, at the enrollment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents |
| Level of Appreciation of the Work | Single-point assessment, at the enrolment | 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 |
| Level of Satisfaction on Involvement in the Decision-making Process of Your Centre | Single-point assessment, at the enrolment | 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. |
| Level of Satisfaction on Professional Career Advancement | Single-point assessment, at the enrolment | 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. |
| Level of Satisfaction on the Decision-making Autonomy | Single-point assessment, at the enrolment | 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. |
| Level of Satisfaction on the Relationship You Have With the Patients | Single-point assessment, at the enrolment | 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. |
| Level of Satisfaction on Protection From Injuries and Professional Risks | Single-point assessment, at the enrolment | 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 |
| Level of Satisfaction on the Management of the Clinic | Single-point assessment, at the enrolment | 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 |
| Level of Satisfaction on the Instruction Given by Doctor About Pain Control | Single-point assessment, at the enrollment | 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 |
| Level of Satisfaction on the Support Received at the Time of the Diagnosis | Single-point assessment, at the enrolment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents |
| Level of Satisfaction on the Involvement by Doctors in Decisions That Affect the Course of Disease | Single-point assessment, at the enrollment | Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents. |
Countries
Nigeria
Participant flow
Recruitment details
4 four clinical centres in Kaduna and Katsina state, Nigeria were involved in the enrollement: Barau Dikko Teaching Hospital Kaduna State University (BDTH), Ahmadu Bello University Teaching Hospital Zaria (ABUTH), National Hospital Abuja (NHA), Federal Medical Centre Katsina (FMC). Centres were selected to be easily accessible to the principal investigator and his collaborators. A random and purposive sampling technique was adopted. Recruitment started in August 2020 and ended in October 2020.
Participants by arm
| Arm | Count |
|---|---|
| SCD Patients or Parents of Children With SCD SCD patients or parents/legally designated representatives of children with SCD attending the selected facilities | 108 |
| Healthcare Professionals Working in a SCD Clinic Healthcare professionals working in a SCD clinic having at least 5 years of experience with SCD patients | 84 |
| Total | 192 |
Baseline characteristics
| Characteristic | Healthcare Professionals Working in a SCD Clinic | Total | SCD Patients or Parents of Children With SCD |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 192 Participants | 108 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Nigeria | 84 participants | 192 participants | 108 participants |
| Sex/Gender, Customized Sex Female | 40 Participants | 91 Participants | 51 Participants |
| Sex/Gender, Customized Sex Male | 40 Participants | 89 Participants | 49 Participants |
| Sex/Gender, Customized Sex unknown | 4 Participants | 12 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Level of Global Satisfaction on the Work With SCD Patients
Likert scale from 1 (very dissatisfied) to 5 (very satisfied)
Time frame: Single-point assessment, at the enrolment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Global Satisfaction on the Work With SCD Patients | 4.17 score on a scale | Standard Deviation 0.69 |
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.
Time frame: Single-point, at the enrollment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction About Nursing Care in Clinic | 4.22 score on a scale | Standard Deviation 0.74 |
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.
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on Responsibility | 4.22 score on a scale | Standard Deviation 0.72 |
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.
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on SCD Current Treatment and Management | 4.12 score on a scale | Standard Deviation 0.76 |
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
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Rating of the Facilities to Manage SCD Patients | 4.12 score on a scale | Standard Deviation 0.85 |
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.
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Rating of the Overall Service Quality | 4.37 score on a scale | Standard Deviation 0.62 |
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
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Appreciation of the Work | 4.25 score on a scale | Standard Deviation 0.73 |
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.
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction in Communicating With Lab Technicians | 4.07 score on a scale | Standard Deviation 0.61 |
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
Time frame: Single-point assessment, at the enrollment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction in Communicating With Nurses | 4.19 score on a scale | Standard Deviation 0.74 |
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.
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on Involvement in the Decision-making Process of Your Centre | 4.06 score on a scale | Standard Deviation 0.88 |
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.
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on Professional Career Advancement | 4.12 score on a scale | Standard Deviation 0.78 |
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
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on Protection From Injuries and Professional Risks | 4.00 score on a scale | Standard Deviation 0.85 |
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
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on the Communication About Sickle Cell Disease and Its Treatment | 4.25 score on a scale | Standard Deviation 0.81 |
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.
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on the Decision-making Autonomy | 4.11 score on a scale | Standard Deviation 0.94 |
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
Time frame: Single-point assessment, at the enrollment
Population: SCD patients or parents of children with SCD
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on the Instruction Given by Doctor About Pain Control | 4.33 units on a scale | Standard Deviation 0.76 |
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.
Time frame: Single-point assessment, at the enrollment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on the Involvement by Doctors in Decisions That Affect the Course of Disease | 4.35 units on a scale | Standard Deviation 0.7 |
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
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on the Management of the Clinic | 4.17 score on a scale | Standard Deviation 0.69 |
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.
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on the Relationship You Have With the Patients | 4.49 units on a scale | Standard Deviation 0.55 |
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
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on the Services Provided in the Lab | 4.12 score on a scale | Standard Deviation 0.66 |
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
Time frame: Single-point assessment, at the enrolment
Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCD Patients | Level of Satisfaction on the Support Received at the Time of the Diagnosis | 4.33 units on a scale | Standard Deviation 0.77 |