Trial Outcomes & Findings for 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 (NCT NCT04505969)

Results Overview

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Recruitment status

COMPLETED

Target enrollment

192 participants

Primary outcome timeframe

Single-point assessment, at the enrolment

Results posted on

2024-05-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	SCD Patients or Parents of Children With SCD SCD patients or parents/legally designated representatives of children with SCD attending the selected facilities	Healthcare Professionals Working in a SCD Clinic Healthcare professionals working in a SCD clinic having at least 5 years of experience with SCD patients
Overall Study STARTED	108	84
Overall Study COMPLETED	108	84
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SCD Patients or Parents of Children With SCD n=108 Participants SCD patients or parents/legally designated representatives of children with SCD attending the selected facilities	Healthcare Professionals Working in a SCD Clinic n=84 Participants Healthcare professionals working in a SCD clinic having at least 5 years of experience with SCD patients	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=108 Participants	0 Participants n=84 Participants	0 Participants n=192 Participants
Age, Categorical Between 18 and 65 years	108 Participants n=108 Participants	84 Participants n=84 Participants	192 Participants n=192 Participants
Age, Categorical >=65 years	0 Participants n=108 Participants	0 Participants n=84 Participants	0 Participants n=192 Participants
Sex/Gender, Customized Sex · Male	49 Participants n=108 Participants	40 Participants n=84 Participants	89 Participants n=192 Participants
Sex/Gender, Customized Sex · Female	51 Participants n=108 Participants	40 Participants n=84 Participants	91 Participants n=192 Participants
Sex/Gender, Customized Sex · unknown	8 Participants n=108 Participants	4 Participants n=84 Participants	12 Participants n=192 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Nigeria	108 participants n=108 Participants	84 participants n=84 Participants	192 participants n=192 Participants

PRIMARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Outcome measures

Outcome measures
Measure	SCD Patients n=106 Participants SCD patients or parents of children with SCD
Level of Satisfaction on SCD Current Treatment and Management	4.12 score on a scale Standard Deviation 0.76

PRIMARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Likert scale from 1 (very poor) to 5 (very good). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Outcome measures

Outcome measures
Measure	SCD Patients n=103 Participants SCD patients or parents of children with SCD
Rating of the Overall Service Quality	4.37 score on a scale Standard Deviation 0.62

PRIMARY outcome

Timeframe: Single-point, at the enrollment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Outcome measures

Outcome measures
Measure	SCD Patients n=108 Participants SCD patients or parents of children with SCD
Level of Satisfaction About Nursing Care in Clinic	4.22 score on a scale Standard Deviation 0.74

PRIMARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with 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

Outcome measures

Outcome measures
Measure	SCD Patients n=83 Participants SCD patients or parents of children with SCD
Rating of the Facilities to Manage SCD Patients	4.12 score on a scale Standard Deviation 0.85

PRIMARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD patients

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.

Outcome measures

Outcome measures
Measure	SCD Patients n=83 Participants SCD patients or parents of children with SCD
Level of Satisfaction on Responsibility	4.22 score on a scale Standard Deviation 0.72

PRIMARY outcome

Timeframe: Single-point assessment, at the enrolment

Likert scale from 1 (very dissatisfied) to 5 (very satisfied)

Outcome measures

Outcome measures
Measure	SCD Patients n=83 Participants SCD patients or parents of children with SCD
Level of Global Satisfaction on the Work With SCD Patients	4.17 score on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD 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

Outcome measures

Outcome measures
Measure	SCD Patients n=84 Participants SCD patients or parents of children with SCD
Level of Appreciation of the Work	4.25 score on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD 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

Outcome measures

Outcome measures
Measure	SCD Patients n=83 Participants SCD patients or parents of children with SCD
Level of Satisfaction on Protection From Injuries and Professional Risks	4.00 score on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD 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

Outcome measures

Outcome measures
Measure	SCD Patients n=83 Participants SCD patients or parents of children with SCD
Level of Satisfaction on the Management of the Clinic	4.17 score on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Single-point assessment, at the enrollment

Population: SCD patients or parents of children with SCD

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

Outcome measures

Outcome measures
Measure	SCD Patients n=108 Participants SCD patients or parents of children with SCD
Level of Satisfaction on the Instruction Given by Doctor About Pain Control	4.33 units on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Outcome measures

Outcome measures
Measure	SCD Patients n=107 Participants SCD patients or parents of children with SCD
Level of Satisfaction on the Support Received at the Time of the Diagnosis	4.33 units on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Single-point assessment, at the enrollment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Outcome measures

Outcome measures
Measure	SCD Patients n=108 Participants SCD patients or parents of children with SCD
Level of Satisfaction on the Involvement by Doctors in Decisions That Affect the Course of Disease	4.35 units on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Outcome measures

Outcome measures
Measure	SCD Patients n=108 Participants SCD patients or parents of children with SCD
Level of Satisfaction on the Services Provided in the Lab	4.12 score on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Outcome measures

Outcome measures
Measure	SCD Patients n=107 Participants SCD patients or parents of children with SCD
Level of Satisfaction on the Communication About Sickle Cell Disease and Its Treatment	4.25 score on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents.

Outcome measures

Outcome measures
Measure	SCD Patients n=107 Participants SCD patients or parents of children with SCD
Level of Satisfaction in Communicating With Lab Technicians	4.07 score on a scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: Single-point assessment, at the enrollment

Population: This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Likert scale from 1 (very dissatisfied) to 5 (very satisfied). This Outcome Measure was pre-specified to be measured in only SCD patients/parents

Outcome measures

Outcome measures
Measure	SCD Patients n=108 Participants SCD patients or parents of children with SCD
Level of Satisfaction in Communicating With Nurses	4.19 score on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD 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.

Outcome measures

Outcome measures
Measure	SCD Patients n=84 Participants SCD patients or parents of children with SCD
Level of Satisfaction on the Relationship You Have With the Patients	4.49 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD 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.

Outcome measures

Outcome measures
Measure	SCD Patients n=83 Participants SCD patients or parents of children with SCD
Level of Satisfaction on Involvement in the Decision-making Process of Your Centre	4.06 score on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD 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.

Outcome measures

Outcome measures
Measure	SCD Patients n=82 Participants SCD patients or parents of children with SCD
Level of Satisfaction on Professional Career Advancement	4.12 score on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: Single-point assessment, at the enrolment

Population: This Outcome Measure was pre-specified to be measured in only healthcare professionals working with SCD 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.

Outcome measures

Outcome measures
Measure	SCD Patients n=82 Participants SCD patients or parents of children with SCD
Level of Satisfaction on the Decision-making Autonomy	4.11 score on a scale Standard Deviation 0.94

Adverse Events

SCD Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthcare Professionals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Principal investigator

Barau Dikko Teaching Hospital, Kaduna State University

Phone: +2348066664042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place