NCT04930185

Brief Summary

The COVID-19 pandemic has spread to over 200 countries worldwide and is still on the rise in 88 countries. Unfortunately, Malaysia is not the exception and registered 340,642 COVID-19 cases till 29 March 2021 since the outbreak of the pandemic. COVID-19 virus can be transmitted from an infected person to others through droplets when coughing or sneezing as well as by touching objects infected with the virus. Although precautionary measures, which include the regular and mandatory use of face masks, reducing crowds, and physical distancing, have been widely encouraged by WHO and the Malaysian government, getting COVID-19 vaccination remain the way forward to curb the wide spread of the virus and to return to the normal. However, the public awareness on the importance of getting vaccinated is still low with high level of vaccination hesitance and refusal. In Malaysia, this challenge is compounded further due to a lack of COVID-19 vaccination educational intervention programme in Bahasa Malaysia to educate the predominantly larger group in the population who are more conversant in ther national language. In order to improve the acceptance rate towards the COVID-19 vaccination in Malaysia, it is imperative to design a comprehensive intervention program that will increase the awareness and knowledge with regards to the efficacy of the COVID-19 vaccine as a solution in overcoming this pandemic. With this in mind, this study aims to identify the correlational factors of COVID-19 and develop an educational intervention programme on COVID-19 vaccination and thereafter, assess the effectiveness of this educational intervention programme.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

June 3, 2021

Last Update Submit

June 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reducing Vaccine Hesitancy

    The vaccine hesitancy scale

    17 months

Secondary Outcomes (1)

  • Reducing Vaccine Hesitancy

    17 months

Study Arms (3)

Pamphlet

EXPERIMENTAL

Participants will received pamphlet about COVID-19 vaccination

Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme

Webinar

EXPERIMENTAL

Participants will received webinar about COVID-19 vaccination

Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme

SMS

EXPERIMENTAL

Participants will received SMS about COVID-19 vaccination

Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme

Interventions

Participants will be receiving the pamphlet about the COVID-19 vaccination information during the intervention. They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention. Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated.

Pamphlet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 18 years and above
  • Able to provide informed consent (verbal/written) to participate
  • Understand either Bahasa Malaysia
  • Participants who have not received their COVID-19 vaccination
  • Participants who have access to smart phone and/or mobile phone
  • Participants who have access to internet.

You may not qualify if:

  • Those who have had any prior history of psychological or neurological illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunway University

Petaling Jaya, Selangor, 47500, Malaysia

Location

Central Study Contacts

Pei Boon Ooi, Doctorate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Teaching Fellow

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 18, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations