Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001350213
Ethics application status
Approved
Date submitted
7/08/2018
Date registered
10/08/2018
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of health education on sleep quality of healthcare workers in Malaysia government health clinics
Scientific title
Effect of Sleep Health Education Module (SHEM) on the sleep quality and sleep hygiene practice of healthcare workers in health clinics, Gombak
Secondary ID [1] 295755 0
None
Universal Trial Number (UTN)
U1111-1218-6581
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep quality 309155 0
Condition category
Condition code
Mental Health 308037 308037 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health education
Phase one - one day health education, discussion and group presentation
- Delivered by medical officer with minimum 5 years' experience
- Mode of delivery: face to face
- One session of 8 hours seminar to be given to participants
- Seminar details (duration 8 hours)
i. 1st health talk (45 minutes presentation, 10 quiz, 5 minutes Q&A) that covers sleep physiology ie sleep stages, and importance of sleep.
ii. 2nd health talk (45 minutes presentation, 10 quiz, 5 minutes Q&A) that covers components of sleep quality, risk factors, adverse health outcome and non-health implications due to poor sleep quality, and sleep disorders.
iii. 3rd health talk (45 minutes presentation, 10 quiz, 5 minutes Q&A) that covers ten sleep hygiene practices and other behavioural approaches to improve sleep quality.
iv. Lunch break & prayer (60 minutes)
v Group discussion (120 minutes) with one group consists of 4 participants who will discuss on how to incorporate the concept of health belief model into the application of sleep hygiene practice in their daily lives, and how to improve their sleep quality in long term.
vi. Group presentation (120 minutes) with each group given 20 minutes to present their discussion outcome using visual aids.
Phase two - weekly text messages for four consecutive weeks as reminders.
1st message: reminders for five sleep hygiene practices using mnemonic TIDUR (sleep in Malay language).
2nd message: reminders for another five sleep hygiene practices using mnemonic SLEEP.
3rd message: reminders on seven indicators of good sleep quality.
4th message: reminders of benefits (individual, career, social) by improving sleep quality with sleep hygiene practice.
Intervention code [1] 312087 0
Behaviour
Comparator / control treatment
One day health education using existing module on mercury spillage in health facilities to the control group
- Duration: 8 hours
- Delivered by medical officer of minimum 5 years of experience
- Mode of delivery:face to face
- Content:
i. Introduction to mercury (90 minutes): properties of mercury, level of toxicity, sources of mercury in health facilities, adverse health effects
ii. Mercury spillage management (150 minutes): preparation of spillage kit & personal protective equipment, notification of incident, algorithm of response process, steps in decontamination, proper disposal of mercury, management of patient in contact with mercury.
iii. Lunch break & prayer (60 minutes)
iv. Practical session (180 minutes) on preparedness phase, response phase, recovery phase in mercury spillage management.

Control group to receive the similar intervention as intervention group after the 3 month follow up period.
Control group
Placebo

Outcomes
Primary outcome [1] 307027 0
Change in sleep quality based on Pittsburgh Sleep Quality Index
study instrument - self administered questionnaire
Timepoint [1] 307027 0
three months post intervention
Secondary outcome [1] 350425 0
Change in sleep hygiene practice based on Sleep Hygiene Practice Scale
study instrument - self administered questionnaire
Timepoint [1] 350425 0
three months post intervention

Eligibility
Key inclusion criteria
All healthcare workers working in government health clinics in Gombak district
Minimum age
21 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any healthcare workers who is not available during the study period
2. Any healthcare workers who is mentally not sound to answer the questionnaire

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size determination is based on formula used for cluster RCT with a fixed number of cluster but unequal cluster size. The pre-determined cluster size is 5. 20% non-response rate is also taken into consideration.
Generalized Estimating Equations (GEE) is used to assess the differences within and between groups. Intention to treat analysis will also be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/04/2018
Date of last participant enrolment
Anticipated
Actual
31/07/2018
Date of last data collection
Anticipated
31/01/2019
Actual
31/03/2019
Sample size
Target
256
Accrual to date
Final
256
Recruitment outside Australia
Country [1] 20734 0
Malaysia
State/province [1] 20734 0
Selangor

Funding & Sponsors
Funding source category [1] 300346 0
University
Name [1] 300346 0
Universiti Putra Malaysia
Country [1] 300346 0
Malaysia
Primary sponsor type
University
Name
University Putra Malaysia
Address
Faculty of Medicine and Health Sciences,
43400 UPM Serdang, Selangor Daruh Ehsan
Country
Malaysia
Secondary sponsor category [1] 299789 0
None
Name [1] 299789 0
Address [1] 299789 0
Country [1] 299789 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301162 0
Medical Research Ethics Committee
Ethics committee address [1] 301162 0
Secretariat of National Institutes of Health (NIHSEC)
c/o Institute for Health Management
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur
Ethics committee country [1] 301162 0
Malaysia
Date submitted for ethics approval [1] 301162 0
14/03/2017
Approval date [1] 301162 0
14/04/2017
Ethics approval number [1] 301162 0
NMRR-17-415-34543(IIR)

Summary
Brief summary
A randomized controlled trial study will be conducted in the Gombak district government health clinics. This study aims to develop, implement and evaluate the effectiveness of HBM driven intervention program on the HCWs sleep quality. The significance of the study is to identify the modifiable risk factors among HCW in sleep for intervention in order to promote the sustainability of healthy sleep practice and good sleep quality via intrapersonal behaviour change.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2941 2941 0 0
/AnzctrAttachments/375749-MREC Aprroval Letter 34543_20170419_091907_461.pdf (Ethics approval)
Attachments [2] 2942 2942 0 0
/AnzctrAttachments/375749-PIS & Consent Eng 12 Mar.pdf (Participant information/consent)

Contacts
Principal investigator
Name 86054 0
Dr Ming Keong Wan
Address 86054 0
Faculty of Medicine and Health Sciences,
43400 UPM Serdang, Selangor Daruh Ehsan.
Country 86054 0
Malaysia
Phone 86054 0
60133500503
Fax 86054 0
60389450151
Email 86054 0
[email protected]
Contact person for public queries
Name 86055 0
Ming Keong Wan
Address 86055 0
Faculty of Medicine and Health Sciences,
43400 UPM Serdang, Selangor Daruh Ehsan.
Country 86055 0
Malaysia
Phone 86055 0
60133500503
Fax 86055 0
60389450151
Email 86055 0
[email protected]
Contact person for scientific queries
Name 86056 0
Titi Rahmawati Hamedon
Address 86056 0
Faculty of Medicine and Health Sciences,
43400 UPM Serdang, Selangor Daruh Ehsan.
Country 86056 0
Malaysia
Phone 86056 0
+60126498088
Fax 86056 0
60389450151
Email 86056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
to protect participants' confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.