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Trial registered on ANZCTR
Registration number
ACTRN12621001373864
Ethics application status
Approved
Date submitted
28/09/2020
Date registered
11/10/2021
Date last updated
11/10/2021
Date data sharing statement initially provided
11/10/2021
Date results information initially provided
11/10/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Psychological First Aid Training of Nurses For Disaster Preparedness: A Non-Equivalent Control Group Study
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Scientific title
Psychological First Aid Training of Nurses For Disaster Preparedness: A Non-Equivalent Control Group Study
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Secondary ID [1]
297235
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None
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Universal Trial Number (UTN)
U1111-1258-7647
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety
319199
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Post-traumatic stress disorder (PTSD)
323502
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Poor psychological preparedness
323503
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Condition category
Condition code
Mental Health
317166
317166
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0
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Anxiety
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Mental Health
317167
317167
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The psychological first aid (PFA) training programme was modified from the RAPID-PFA, which was developed by Johns Hopkins Center for Public Health Preparedness. The modified programme was nine hours long and was delivered over five weeks (the first four weeks were two hours long and the last week was 1 hour), with interactive didactic lectures, group discussions, and the addition of simulation simulated role-play exercises based on disaster scenarios relevant to the Palestinian situation. The core competencies of the modified and adopted RAPID-PFA training incorporated the five essential elements of immediate mass trauma intervention (safety, calming, self-and collective efficacy, connectedness, and hope).
The PFA trainer who was invited to conduct the training was a licensed psychologist from the organisation Médecins Sans Frontières/Doctors Without Borders (MSF), Doctors of the World, or World Vision, who had extensive experience as an emergency and trauma responder. The trainer attended the online version of RAPID-PFA to understand this version of PFA.
The study used a non-equivalent control group design with pre-and post-test. However, simple randomisation was used by drawing two hospitals to allocate the intervention arm, then the other three hospitals to form the control arm ((wait-listed)). To avoid contamination, nurses were allocated either to the intervention or control group by individual hospitals. The study included five hospitals in the Nablus and Ramallah cities in the West Bank, Palestine.
Some strategies used during the intervention to ensure fidelity: The researcher assessed whether participated nurses understood the intervention content and how relevant they thought the intervention was to their work (nursing day work), for example, follow-up questions and discussions. The researcher tracked attendance at each session and conducting a pre-posttest to assess their improvement following the intervention. Furthermore, the PFA training was delivered by the same trainer, which ensured training fidelity.
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Intervention code [1]
318691
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Treatment: Other
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Comparator / control treatment
Participating nurses in this arm were not included in the Psychological First Aid (PFA) training, and the evaluations were performed based on their existing nursing education and professional experience, but they would be on a waitlist for the modified RAPID-PFA training after the study.
The wait-list may receive the intervention at any time after the completion of the 5 week study when the resources become available.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in Nurses’ psychological preparedness for disaster is assessed by Psychological Preparedness for Disaster Threat Scale (PPDTS) (Zulch et al., 2012).
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Assessment method [1]
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Timepoint [1]
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At baseline and after five weeks (Intervention duration). Using the above scale.
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Secondary outcome [1]
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Change in Nurses' self-efficacy as assessed using General Self-Efficacy Scale (GSE). GSE contains 10 questions on a 4-point scale (1 = not at all true to 4 = exactly true) (Schwarzer and Jerusalem, 1995).
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Assessment method [1]
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Timepoint [1]
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At baseline and after five weeks (Intervention duration). Using the above scale.
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Secondary outcome [2]
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Change in Nurses' self-esteem as assessed by Self-Esteem Scale (SES). The SES (Rosenberg, 1965) has 10 questions in a 4-point Likert scale (1 = strongly agree to 4 = strongly disagree).
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Assessment method [2]
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Timepoint [2]
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At baseline and after five weeks (Intervention duration). Using the above scale.
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Secondary outcome [3]
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Change in Nurses' dispositional optimism as assessed by the Life Orientation Test (LOT). The LOT (Scheier et al.,1994) has 10 questions on a 0 to 4 Likert scale (0 = strongly disagree to 4 = strongly agree).
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Assessment method [3]
400597
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Timepoint [3]
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At baseline and after five weeks (Intervention duration). Using the above scale.
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Secondary outcome [4]
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Change in Nurses' trait Anxiety as assessed by State-trait Anxiety Inventory (STAI)(Spielberger et al., 1983), and the items are rated on a 4-point scale (From “Almost Never” to “Almost Always”).
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Assessment method [4]
400598
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Timepoint [4]
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At baseline and after five weeks (Intervention duration). Using the above scale.
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Secondary outcome [5]
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Change in Nurses PTSD as assessed by PTSD Diagnostic Scale for DSM-5 (PDS-5). The PDS-5 (Foa et al., 2015) is a 24-item questionnaire with a 5-point Likert scale (0 = Not at all to 4 = severe).
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Assessment method [5]
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Timepoint [5]
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At baseline and after five weeks (Intervention duration). Using the above scale.
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Secondary outcome [6]
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Change in Nurses' PFA knowledge, attitude, and skills, as assessed by PFA scale developed by Everly et al. (2014) that aimed at 1) measuring knowledge (understanding PFA concepts) (ten items: four multiple choices and six true/false); 2) assessing skills in the application of PFA (perceived self-efficacy) (10 items); and 3) evaluating attitudes (self-confidence) in providing PFA (10 items). The items are structured in a 5-point Likert scale (1 = very unconfident to 5 = don't know; and 1 = very unprepared to 5 = don't know).
The used scale was one scale and has three dimensions (knowledge, attitude, and skills).
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Assessment method [6]
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Timepoint [6]
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At baseline and after five weeks (Intervention duration). Using the above scale.
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Eligibility
Key inclusion criteria
1. Nurses working in the Emergency Department or Critical care units or Trauma departments/units.
2. Minimum one year experience.
3. Full-time hospital work.
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Statistical analysis was performed using SPSS, version 25. Descriptive statistics were used to summarise participant characteristics. Normality of the PPDTS distribution was evaluated with skewness and kurtosis from the Shapiro-Wilk test. The Alpha was set at the level of p < .05. Chi-square and Mann-Whitney U test were used to check for any significant group differences in demographics and outcome variables between the control and experiment groups at baseline.
The analysis considered ITT principle, then the fully conditional specification (FCS) method (creating several "complete" sets of data) with the imputations by the number of the percentage of missing values was performed. During each imputation, the missing values were imputed and at the end of all imputations, the values were averaged together to estimate the variance of the missing values. Finally, the required number of imputed datasets was generated.
Generalized Estimating equations (GEE) model was used to assess any changes in the outcome variables between the control and experiment groups across the pre- and post-test study period (i.e. group by time interaction effect).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
3/06/2019
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Date of last participant enrolment
Anticipated
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Actual
14/06/2019
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Date of last data collection
Anticipated
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Actual
8/08/2019
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Sample size
Target
168
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Accrual to date
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Final
168
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Recruitment outside Australia
Country [1]
23016
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Palestinian Territory, Occupied
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State/province [1]
23016
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West Bank
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Funding & Sponsors
Funding source category [1]
301790
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Hospital
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Name [1]
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An Najah National University Hospital
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Address [1]
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Asirah Street, Nablus
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Country [1]
301790
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Palestinian Territory, Occupied
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Funding source category [2]
308580
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Hospital
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Name [2]
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Rafedia Hospital
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Address [2]
308580
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Rafedia street, Nablus
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Country [2]
308580
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Palestinian Territory, Occupied
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Primary sponsor type
University
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Name
The Hong Kong Polytechnic University
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Address
Hong Chong Rd, Hung Hom, Hong Kong
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Country
Hong Kong
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Secondary sponsor category [1]
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University
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Name [1]
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An Najah National University
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Address [1]
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Rafedia, Nablus, West Bank
P.O.BOX 7
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Country [1]
301533
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Palestinian Territory, Occupied
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302502
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Human Subjects Ethics Sub-committee (HSESC) at The Hong Kong Polytechnic University
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Ethics committee address [1]
302502
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The Hong Kong Polytechnic University, Hong Chong Rd, Hung Hom, Hong Kong
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Ethics committee country [1]
302502
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Hong Kong
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Date submitted for ethics approval [1]
302502
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10/01/2019
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Approval date [1]
302502
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29/01/2019
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Ethics approval number [1]
302502
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HSEARS20190118001
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Ethics committee name [2]
306990
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Institutional Review Board at An-Najah National University
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Ethics committee address [2]
306990
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An-Najah National University
Nablus, West Bank, Palestine.
PO. Box 7.
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Ethics committee country [2]
306990
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Palestinian Territory, Occupied
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Date submitted for ethics approval [2]
306990
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01/05/2019
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Approval date [2]
306990
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14/05/2019
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Ethics approval number [2]
306990
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IRB(12)April2019
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Summary
Brief summary
After a survey as phase I of the research project, the aim of this study is to determine if
psychological first aid (PFA) training may achieve, (a) psychological preparedness of nurses for disasters; and (b) promotion of a sense of self-efficacy, dispositional optimism, and self-esteem and minimizing trait anxiety and PTSD that represent one’s own capabilities in psychological preparedness to disasters. The study will involve your participation in the PFA training which will take about 9 hours (2 hours per week), and completion of a set of questionnaires before and after the training. The questionnaires will take you about twenty minutes to complete, which are designed to obtain demographic information; knowledge about disaster preparedness; self-efficacy; self-confidence as a PFA provider; psychological preparedness for disasters; self-efficacy; individual differences in optimism versus pessimism; anxiety level as a personal characteristic; self-esteem; and PTSD.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Vico Chiang
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Address
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School of Nursing, The Hong Kong Polytechnic University, Hong Chong Rd, Hung Hom, Hong Kong
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Country
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Hong Kong
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Phone
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+852 2766 6683
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Fax
90434
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+852 2364 9663
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Email
90434
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[email protected]
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Contact person for public queries
Name
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Dr Vico Chiang
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Address
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School of Nursing, The Hong Kong Polytechnic University, Hong Chong Rd, Hung Hom, Hong Kong
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Country
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Hong Kong
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Phone
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+852 2766 6683
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Fax
90435
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+852 2364 9663
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Email
90435
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[email protected]
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Contact person for scientific queries
Name
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Dr Vico Chiang
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Address
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School of Nursing, The Hong Kong Polytechnic University, Hong Chong Rd, Hung Hom, Hong Kong
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Country
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Hong Kong
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Phone
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+852 2766 6683
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Fax
90436
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+852 2364 9663
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Email
90436
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
9299
Informed consent form
Said, N. B. (2020). Psychological First Aid Training of Nurses for Disaster Preparedness: A non-equivalent control group study [Unpublished doctoral dissertation]. The Hong Kong Polytechnic University. Hong Kong.
[email protected]
376844-(Uploaded-28-09-2020-04-51-49)-Study-related document.doc
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.
Download to PDF