Condition category
Infections and Infestations
Date applied
19/05/2017
Date assigned
23/06/2017
Last edited
20/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Gamil Alrubaiee

ORCID ID

http://orcid.org/0000-0003-2468-6732

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)/F2

Study information

Scientific title

Effectiveness of nosocomial infection control education module for nurses in public hospital in Azal region, Yemen

Acronym

Study hypothesis

1. 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

Ethics Committee for Research involving Human Subjects of University Putra Malaysia (JKEUPM), 06/02/2015, ref: UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)

Study design

Single-blinded randomised community trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Nurses' knowledge and practices regarding nosocomial infection control measures before and immediately post-intervention and three months after.

Intervention

This 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 type

Behavioural

Phase

Drug names

Primary outcome measures

1. 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 measures

There are no secondary outcome measures.

Overall trial start date

01/04/2015

Overall trial end date

30/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

540 NURSES

Participant exclusion criteria

Foreign nurses

Recruitment start date

08/06/2015

Recruitment end date

12/12/2015

Locations

Countries of recruitment

Yemen

Trial participating centre

Public hospitals
Azal Region
Sana'a
2124
Yemen

Sponsor information

Organisation

Ministry of Higher Education and Scientific Research

Sponsor details

P.O. Box 11327
Sana'a
11327
Yemen
+967 1 274 553
moheyemen@gmail.com

Sponsor type

Government

Website

http://www.yemen.gov.ye

Funders

Funder type

Government

Funder name

Ministry of Higher Education and Scientific Research Yemen

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the study protocol and then planned publication of the results in a high impact peer reviewed journal.

IPD sharing statement:
The 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

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes