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Effectiveness of Medicorp HO Preparatory Course

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03510195
Recruitment Status : Completed
First Posted : April 27, 2018
Results First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Aneesa Abdul Rashid, Universiti Putra Malaysia

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Psychological Stress
Depressive Symptoms
Anxiety State
Motivation
Intervention Other: MEDICORP HO PREPARATORY MODULE
Enrollment 267
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants in Medicorp HO Preparatory Module
Hide Arm/Group Description A total of 267 participants registered for the course and were invited to participate within the timeframe of this study period of recruitment. Only 239 returned their baseline questionnaires. At the time-point immediately after the intervention, 224 participants returned their completed questionnaires. At the subsequent follow up of the study, which was one-month post working as a HO, 101 answered the questionnaire.
Period Title: Overall Study
Started 267
Completed 101
Not Completed 166
Arm/Group Title Sociodemographic Factors of Participants
Hide Arm/Group Description Data and results obtained from pre-intervention, post intervention and 1 month after work post intervention
Overall Number of Baseline Participants 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 239 participants
25.66  (1.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
Female
186
  77.8%
Male
53
  22.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
Malay
189
  79.1%
Chinese
19
   7.9%
Indian
19
   7.9%
Others
12
   5.0%
Religion  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
Islam
194
  81.2%
Christian
18
   7.5%
Hindu
16
   6.7%
Buddha
7
   2.9%
Others
4
   1.7%
Year of Graduation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
2016
2
   0.8%
2017
81
  33.9%
2018
156
  65.3%
Place of Graduation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
Local
63
  26.4%
Overseas
176
  73.6%
1.Primary Outcome
Title Change in Confidence Level
Hide Description This will be adapted from the IMU Student Competency Survey (Appendix 2) as there are no published studies on the confidence level of medical graduates before beginning HO-ship. The questionnaire comprises of 5 sections. The first 4 sections asses on generic skills, practical tasks, soft skills and their confidence as a whole, using a Likert scale assessment. Scoring is a mean score of 1-5 and the higher the score, the higher the confidence. The last section asks on the one daunting aspect of being a HO out of a list of 7 things, this section is descriptive.
Time Frame pre intervention, immediately after intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-intervention Post-intervention Post 1 Month Working
Hide Arm/Group Description:
The participants assessed before the preparatory course started.
The participant assessed after the preparatory course ended.
The participant assessed after 1 month working.
Overall Number of Participants Analyzed 239 224 101
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.18  (1.00) 3.50  (0.75) 3.79  (0.92)
2.Secondary Outcome
Title Change in Readiness Level
Hide Description This is also adapted from the IMU competency survey and is asked on a likert scale of 1 to 5 for their level of readiness. It is assessed after the confidence section. The higher the score, the higher the level of readiness
Time Frame pre intervention, immediately post intervention (after 3 days of intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-intervention Level of Readiness Post Intervention Level of Readiness
Hide Arm/Group Description:
The participants assessed before the preparatory course started.
The participants assessed after the preparatory course ended.
Overall Number of Participants Analyzed 239 224
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.36  (1.03) 3.46  (0.78)
3.Secondary Outcome
Title Change in Psychological Well Being - Depression
Hide Description

This is using the Depression Anxiety Stress Scale (DASS): This questionnaire is used to asses Depression, Anxiety and Stress. It uses a likert scale. The scores indicate normal, mild, moderate, severe and extremely severe for each of the domains. The higher the scores, indicates the more severe the conditions.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia.

Minimum score: 0 Maximum score: 42

Normal: 0-9 Mild: 10-13 Moderate: 14-20 Severe: 21-27 Exteremely severe: 28+

Time Frame pre intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-intervention DASS-depression Post 1 Month Working DASS-depression
Hide Arm/Group Description:
The participant assessed before the preparatory course started via DASS questionnaire.
The participants assessed after the preparatory course ended via DASS questionnaire.
Overall Number of Participants Analyzed 239 101
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.67  (7.93) 7.80  (8.95)
4.Secondary Outcome
Title Change in Psychological Well Being - Anxiety
Hide Description

This is using the Depression Anxiety Stress Scale (DASS): This questionnaire is used to asses Depression, Anxiety and Stress. It uses a likert scale. The scores indicate normal, mild, moderate, severe and extremely severe for each of the domains. The higher the scores, indicates the more severe the conditions.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect.

Minimum score: 0 Maximum score: 48

Normal: 0-7 Mild: 8-9 Moderate: 10-14 Severe: 15-19 Extremely severe: 20+

Time Frame pre intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-intervention DASS-anxiety Post 1 Month Working DASS-anxiety
Hide Arm/Group Description:
The participants assessed before the preparatory course via DASS questionnaire.
The participants assessed 1 month after working via DASS questionnaire.
Overall Number of Participants Analyzed 239 101
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.75  (7.24) 7.43  (9.54)
5.Secondary Outcome
Title Change in Psychological Well Being - Stress
Hide Description

This is using the Depression Anxiety Stress Scale (DASS): This questionnaire is used to asses Depression, Anxiety and Stress. It uses a likert scale. The scores indicate normal, mild, moderate, severe and extremely severe for each of the domains. The higher the scores, indicates the more severe the conditions.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

Minimum score: 0 Maximum score: 48

Normal: 0-14 Mild: 15-18 Moderate: 19-25 Severe: 26-33 Extremely severe: 34+

Time Frame pre intervention and 1 month after working as a House Officer ( an average of 6 months after intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-intervention DASS-stress Post 1 Month Working DASS-stress
Hide Arm/Group Description:
The participants assessed before the preparatory course via DASS questionnaire.
The participants assessed 1 month after working via DASS questionnaire.
Overall Number of Participants Analyzed 239 101
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.78  (8.05) 8.58  (10.33)
Time Frame 1 year
Adverse Event Reporting Description

This is an education module, hence, there should be no adverse events. However, in the module there were needle used in practical session. Therefore, needle prick injury can be one of the adverse events that we can include in the study.

The adverse event is somehow monitored but not observed.

 
Arm/Group Title Participants in Medicorp HO Preparatory Module
Hide Arm/Group Description

Pre-intervention: The participants screened based on the exclusion and inclusion criteria leaving the number of 239 participants after registration.

Post-intervention: Drop outs mainly due to failure in submitting the complete post-intervention questionnaires before they headed home.

Post 1 month after work: Major drop outs purely as a result of unavailability to answer and time constraint due to the hectic schedule of a houseman.

All-Cause Mortality
Participants in Medicorp HO Preparatory Module
Affected / at Risk (%)
Total   0/239 (0.00%) 
Hide Serious Adverse Events
Participants in Medicorp HO Preparatory Module
Affected / at Risk (%)
Total   0/239 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants in Medicorp HO Preparatory Module
Affected / at Risk (%)
Total   0/239 (0.00%) 
Poor responses from the participants during follow-ups. Many of the participants are also lost to follow up made the number of drop outs bigger.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Aneesa Abdul Rashid
Organization: Universiti Putra Malaysia
Phone: 03-86092956
EMail: aneesa@upm.edu.my
Layout table for additonal information
Responsible Party: Aneesa Abdul Rashid, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT03510195    
Other Study ID Numbers: upm/uctc/900/3/2/ktgs0518012
First Submitted: April 8, 2018
First Posted: April 27, 2018
Results First Submitted: January 24, 2020
Results First Posted: June 16, 2020
Last Update Posted: June 16, 2020