- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04112680
Contagious Misinformation Trial (CMT)
January 20, 2020 updated by: Helena Nordenstedt, Karolinska Institutet
The Contagious Misinformation Trial: Debunking Prevalent Misinformation About an Infectious Disease Through Audio Dramas in Freetown, Sierra Leone
In the Contagious Misinformation Trial the investigators aim to debunk prevalent misinformation about an infectious disease using two evidence-based methods of debunking.
The two debunking methods are packaged in two audio dramas of 4 episodes each, which will be sent to the WhatsApp of participants who are randomised to intervention group 1 or 2. The control group will receive audio messages about a different topic.
The primary outcome is the reduction in belief in two misinformation statements about the infectious diseases.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
750
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Western Area
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Freetown, Western Area, Sierra Leone
- Focus1000
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults
- Living in Freetown
- In possession of a mobile phone that has WhatsApp
- Fluent in Krio
Exclusion Criteria:
- Deafness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group 1
Audio messages in this group are focussed on providing a Plausible Alternative to the misinformation
|
The audio dramas (one drama of 4 episodes per intervention group), aim to debunk misinformation about an infectious disease.
The content of the two dramas differ in the two groups; in intervention group 1, the drama will state the misinformation and provide a plausible alternative, delivered through a trusted source, in line with world views.
In intervention group 2, the audio drama will avoid mentioning the misinformation and instead only state the correct information about the infectious disease
|
EXPERIMENTAL: Intervention group 2
Audio messages in this group focus on Avoiding the Misinformation and instead only provide the correct information
|
The audio dramas (one drama of 4 episodes per intervention group), aim to debunk misinformation about an infectious disease.
The content of the two dramas differ in the two groups; in intervention group 1, the drama will state the misinformation and provide a plausible alternative, delivered through a trusted source, in line with world views.
In intervention group 2, the audio drama will avoid mentioning the misinformation and instead only state the correct information about the infectious disease
|
PLACEBO_COMPARATOR: Control group
Audio messages in this control group are on a different topic
|
The control group will receive audio jingles about exclusive breastfeeding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the belief in misinformation
Time Frame: Up to 2 months
|
The change in the belief in misinformation will be measured through Yes/No questions in the baseline and follow-up surveys.
Using logistic regression models, the prevalence of the belief in misinformation about 2 aspects of an infectious disease compared to the control group will be analysed using an intention-to-treat and per-protocol analysis
|
Up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inadvertent promotion of misinformation: the backfire effect
Time Frame: Up to 2 months
|
To test whether the interventions might inadvertently have promoted the belief in misinformation, the same yes/no questions as the primary outcome will be used in ordinal logistic regression models to analyse if the there has been a backfire effect in the intervention groups, compared to the control group.
|
Up to 2 months
|
As treated analysis of primary outcomes
Time Frame: Up to 2 months
|
The Yes/No questions of the primary outcomes will be tested in an as-treated analysis.
The investigators will only include participants who can correctly recall the basic storylines of the audio messages.
|
Up to 2 months
|
Knowledge about preventive methods
Time Frame: Up to 2 months
|
Using an open question, asking the respondent to name up to 3 preventive methods, a score will be created.
For every correct answer, the participants gets a point, and one point is subtracted for every wrong answer; leading to a potential score of -3 to +3.
Ordinal logistic regression models will be fitted to compare the scores of the intervention groups with the control group.
|
Up to 2 months
|
Health-related discussions among family/friend
Time Frame: Up to 2 months
|
The question asking whether the participant has discussed the content of the audio messages will be used for this analysis, together with the question about how often the participant discussed health issues with family/friends.
Logistic regression models will be fitted to test whether the interventions have influenced health-related discussions with family or friends, as compared to the control group.
|
Up to 2 months
|
Method of administration
Time Frame: Up to 2 months
|
To understand if the intervention works outside of WhatsApp, 60 additional people will be recruited who do not have WhatsApp.
Participants will instead be called and listen to the audio dramas on the phone; 30 will listen to the audio drama of intervention group 1 and 30 will listen to the audio drama of intervention group 2. The two primary outcomes will be analysed similar to the primary outcome analysis (ITT and per protocol) among the 2 groups and compared to the control group, as well as to their equivalent group of respondents with WhatsApp.
|
Up to 2 months
|
Differences in self-efficacy
Time Frame: Up to 2 months
|
Participants will answer 3 questions about their perceived self-efficacy on 3 specific preventive behaviours.
Answers are on a 5-item scale: from not at all true to exactly true.
Ordinal logistic regression models will be specified to test whether the interventions had an influence on people's self-efficacy about three specific preventive behaviours, compared to the control group.
|
Up to 2 months
|
Risk perception & preventive methods
Time Frame: Up to 2 months
|
Risk perception about the infectious disease will be measured with a question that asks how likely it is that the participants gets the disease in the next year.
A question which asks what kind of actions the participants has undertaken, or is planning to undertake, to prevent infection with the disease - will be used to assess if and what kind of actions are taken.
Several analyses will be carried out to test whether the intervention influenced risk perception and preventive methods.
Furthermore, analyses will be carried out to determine if the a change in risk perception influenced preventive methods.
|
Up to 2 months
|
Objective versus subjective learning
Time Frame: Up to 2 months
|
In the follow-up survey, there is a question asking if the participant feels like he/she learned from the audio messages (yes/no question).
A Chi-Square analysis will be done to determine whether those who feel like they learned also learned objectively, using the two primary outcomes.
|
Up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Helena Nordenstedt, MD PHD, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 7, 2019
Primary Completion (ACTUAL)
December 21, 2019
Study Completion (ACTUAL)
December 21, 2019
Study Registration Dates
First Submitted
September 27, 2019
First Submitted That Met QC Criteria
September 30, 2019
First Posted (ACTUAL)
October 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 20, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMT2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
After publication of the primary analysis and study results, the anonymised data will be published in a public repository
IPD Sharing Time Frame
January 2022
IPD Sharing Supporting Information Type
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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