ISRCTN ISRCTN19992640
DOI https://doi.org/10.1186/ISRCTN19992640
Secondary identifying numbers UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)/F2
Submission date
19/05/2017
Registration date
23/06/2017
Last edited
27/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Nosocomial infections are infections that are contracted from being in a hospital. Infection can be easily spread by healthcare staff to different patients. Nosocomial infection is a major global health problem, and is considered as one of the leading causes of increased morbidity (illness) and mortality (death). Nursing education related to infection control measures can help nurses to make informed decisions to try and prevent or reduce nosocomial infections. Researchers have developed an educational plan for Yemeni nurses working in public hospitals. This plan needs to be evaluated for its effectiveness. The aim of the study is to increase the awareness and knowledge regarding nosocomial infection control measures among Yemeni nurses and subsequently helps them to maintain a high quality of care, and protect themselves, their patients and visitors as well.

Who can participate?
Nurses working at selected Yemeni hospitals.

What does the study involve?
Participating hospitals are randomly allocated to one of three groups. Those in the first group receive an audio-visual educational training and a training course for eight weeks to improve nurses’ knowledge and practices regarding nosocomial infection controls. Those in the second group are given only the audio-video CD education module. Those in the last group are put on a waiting list to be given the same training and learning materials after the study is completed. Participants fill out questionnaires before the study and immediately after the programme as well as three months after the programme to assess their knowledge and practices for infection control.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.

Where is the study run from?
This study is being run by Ministry of Higher Education and Scientific Research (Yemen) and takes place in public hospitals in the Azal region of Yemen.

When is the study starting and how long is it expected to run for?
April 2015 to October 2016

Who is funding the study?
Ministry of Higher Education and Scientific Research (Yemen)

Who is the main contact?
Mr Gamil Alrubaiee

Contact information

Mr Gamil Alrubaiee
Scientific

Department of Community Health
Faculty of Medicine & Health Sciences
University Putra Malaysia
Serdang
Selangor Darul Ehsan
43400 UPM
Malaysia

ORCiD logoORCID ID 0000-0003-2468-6732

Study information

Study designSingle-blinded randomised community trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet ISRCTN19992640_PIS_02Sep13.pdf
Scientific titleEffectiveness of nosocomial infection control education module for nurses in public hospital in Azal region, Yemen
Study objectives1. There is a significant association between scores of nurses’ knowledge and practice and the previous in-service training courses
2. There is a significant association between scores of nurses’ knowledge and practice and the previous working experience
3. There are significant differences in nurses’ knowledge scores between the intervention groups and the wait-list group at baseline, immediately after and three months post-intervention
4. There are significant differences in practice scores between the intervention groups and the wait-list group at baseline, immediately after and three months post-intervention
Ethics approval(s)Ethics Committee for Research involving Human Subjects of University Putra Malaysia (JKEUPM), 06/02/2015, ref: UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)
Health condition(s) or problem(s) studiedNurses' knowledge and practices regarding nosocomial infection control measures before and immediately post-intervention and three months after.
InterventionThis study is conducted in three phases:

Phase one: Module & instrument development
Phase two: Module implementation
Phase three: Module evaluation

During the second phase of the study, the module implementation, participants are randomly assigned based on their hospital to one of three groups. Three arms are formed for the purpose of this study, two of them are intervention groups, while the third one is a wait list group (control group). Eight hospitals are allocated by the ratio 2:2, four hospitals are assigned to the wait list group, and the other four hospitals are allocated evenly to each of the two intervention groups. Assignment to the groups is done by simple randomisation using a table of random numbers generated by Computer. This study is single-blind trail, therefore the researcher is aware about the allocation, while the hospitals are not aware about it until the intervention started, after which blinding is not possible because the intervention hospitals receive the training course.

Three groups are formed for the purpose of this study, two of them are experimental groups, while the third one is a waitlist group, meaning no intervention are received by the participants in this group during the period of data collection but for ethical considerations the wait list group given the same training and learning materials after phase three. All participants fill out a questionnaire prior to the interventions.

Group 1 (Intervention group 1): Participants receive an educational module supported by audio-video CD and training course for eight weeks that aims to improve nurses' knowledge and practices regarding nosocomial infection control measures.

Group 2 (Intervention group 2): Participants are given only the educational module with audio-video CD and not the training course.

Group 3 (Wait list group): Participants receive no intervention during the period of data collection but for ethical considerations the wait list group given the same training and learning materials after phase three.

Participants are followed up with questionnaires immediately post-intervention and three month post-intervention. Correct, incorrect, and I don’t know statements are used to evaluate this dimension (30-items).
Intervention typeBehavioural
Primary outcome measure1. Nurse’s knowledge is measured using the NIs-Questionnaire at baseline, immediately post-intervention, and three month post-intervention
2. Nurses practices is measured using the NIs-Questionnaire at baseline, immediately post-intervention, and three month post-intervention
Secondary outcome measuresThere are no secondary outcome measures.
Overall study start date01/04/2015
Completion date30/10/2016

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participants540 NURSES
Total final enrolment540
Key inclusion criteria1. Yemeni Fully employed nurses working in the selected hospitals
2. Both male and female
3. Have a three year diploma in nursing after secondary school
Key exclusion criteriaForeign nurses
Date of first enrolment08/06/2015
Date of final enrolment12/12/2015

Locations

Countries of recruitment

  • Yemen

Study participating centre

Public hospitals
Azal Region
Sana'a
2124
Yemen

Sponsor information

Ministry of Higher Education and Scientific Research
Government

P.O. Box 11327
Sana'a
11327
Yemen

Phone +967 1 274 553
Email moheyemen@gmail.com
Website http://www.yemen.gov.ye

Funders

Funder type

Government

Ministry of Higher Education and Scientific Research Yemen

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication of the study protocol and then planned publication of the results in a high impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from the researcher Gamil Ghaleb Ahmed Nasr, email address: arubaiee73@gmail.com

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 02/09/2013 26/06/2017 No Yes
Protocol article protocol 01/12/2019 Yes No
Results article 17/02/2021 27/10/2022 Yes No

Additional files

ISRCTN19992640_PIS_02Sep13.pdf
Uploaded 26/06/2017

Editorial Notes

27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
07/11/2019: Internal review.
22/03/2019: Publication reference added.