Information DisclosureCONSENTNCT05341791
Paper Versus Cartoon Video-based Administration of Study Information Notice for Participant Consent
A study testing Cartoon video describing study information notice in people with Information Disclosure, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Cameroon.
Trial summary
This study is a randomized trial in which participants are assigned to one of 2 strategies of information notice administration which include the standard approach versus a video-based cartoon approach. An information notice about the study will be administered to each participant individually. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Information Disclosure
- What is being tested?
- Cartoon video describing study information notice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteCameroon
- Study dates
- 28 Mar 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All adults > = 21 years of age, or emancipated minors (persons between 15-17 years who are married or pregnant/have children or head of a household)
- Are able to speak, read and write English or French
- Bringing their children for routine consultation or immunization in the selected study sites
- Give their written consent to take part to the study
Who cannot join
- Participants with visual or hearing challenges which prevent them from reading written forms or viewing/listening to a video content will be excluded Selection of participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Novel Methods of Study Information Notice Administration to the Standard Approach in Enhancing Clinical Studies Understanding in Resource Limited Settings: A Randomized Trial
This study is a randomized trial in which participants are assigned to one of 2 strategies of information notice administration which include the standard approach versus a video-based cartoon approach. An information notice about the study will be administered to each participant individually. The study involves the integration of tuberculosis screening at all pediatric entry points, and other activities aimed at improving pediatric tuberculosis diagnosis and management. The understanding of participants will be assessed using a test of understanding adapted from the Quality of Informed consent (QIC).
Read the detailed description
Objectives:
Primary Objective: is to evaluate the effectiveness of cartoon video-based study information notice administration compared to standard study information notice administration as assessed by the QIC Secondary Objectives: - Determine the factors associated with effectiveness of the cartoon video-based study information notice administration.
Endpoints:
Primary Endpoint: The proportion of participants scoring more than 80% at the test of understanding, comparing the novel and the standard strategy.
Study Population: Our population will consist of adults bringing their children for routine care in the facilities in which the study will be conducted.
Study Sites This study will be conducted in 4 sites located in the West, Littoral and Center regions of Cameroon. These sites are the District Hospital of Dschang, the district hospital of Foumban, the District hospital of Loum, and the district hospital of Soa. These sites are semi-urban sites and are selected to facilitate inclusion of participants from urban, peri-urban and rural settings. Also, these sites conduct routine systematic and active screening for pediatric tuberculosis of all children presenting for care in the facility, as well as other interventions to improve pediatric tuberculosis diagnosis and management. These tuberculosis activities, which had been implemented by EGPAF through the CaP TB program are now part of the routine sites activities and will be used to build the information notice for the purpose of this study.
Participant's eligibility and recruitment process Eligible participants will be adults (of at least 21 years of age), or emancipated minors bringing their children (of less than 15 years) for routine care in the selected facilities, and able to read and write English or French and who accept to be part of the study. Every day, routine triage registers (and/or immunization registers, depending on the organization of the health facility) will be used to identify parents bringing their children for routine care. Parents whose children have a serial number in the register which is a multiple of 3 will be screened for eligibility to the study and enrolled if eligible and after providing a written consent. A maximum of 10 participants will be enrolled per day. All enrolled participants will be randomly allocated to the intervention arm (video-cartoon) or to standard consenting following a 1:1 ratio.
Description of the information notice to be administered An information notice on the integration of tuberculosis activities at all pediatric entry points will be developed. This information notice will include details on definition of tuberculosis, rationale and process of systematic and active screening for tuberculosis at all pediatric entry points, sample collection and chest X-ray procedures and indications, data collected as part of the TB activities in the sites, risks and benefits of TB screening and diagnosis procedures, and possibility to accept or refuse TB procedures.
Description of Study arms:
There are 2 study arms. The standard administration of information notice consists of a paper-based study information notice which is provided to the participant during a one-to-one conversation with a study staff. The participant either reads the study information notice or it is read to him/her and explained section by section. The video-based study information notice administration consists of a 20 minutes' cartoon video explaining the study which will be played to the participant.
Study Duration: 20 months
Participant Duration in the study: 1 day
- Conditions
- Information Disclosure
- Being tested
- Cartoon video describing study information notice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartoon video describing study information noticeOther
The video will be 20-minutes long, and will consist of graphic depictions (in cartoon style) of the study information content presented in the same flow as the written notice, and explained by a voice-over in the background. The participant will view the video in a quiet room, on a tablet provided by the study staff. The participant will be able to pause the video or rewind it as needed, and view it at his/her desired pace. The video will have an embedded knowledge check at the end of each section, consisting of a background voice asking some questions, pausing (for the participant to think through the correct answers) and then providing the right answers.
| Study group | Role | What they receive |
|---|---|---|
| Standard administration of information notice | No intervention | : During the standard study information administration, the participant will read though the written information notice which will be organized in sections. After each section, the study staff will explain to the participant the key information to understand. Throughout the process, participants will be allowed to ask study staff questions. We anticipate the time to administer consent by this standard approach will be approximately 45 to 60 minutes per participants. |
| video administration of information notice | Experimental | The video will be 20-minutes long, and will consist of graphic depictions (in cartoon style) of the study information content presented in the same flow as the written notice, and explained by a voice-over in the background. The participant will view the video in a quiet room, on a tablet provided by the study staff. The participant will be able to pause the video or rewind it as needed, and view it at his/her desired pace. The video will have an embedded knowledge check at the end of each section, consisting of a background voice asking some questions, pausing (for the participant to think through the correct answers) and then providing the right answers. Receives: Other: Cartoon video describing study information notice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy.
The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start28 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Information DisclosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Boris K Tchounga, MD, PhD, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341791
- Sponsor's protocol ID
- EG0266
- Acronym
- CONSENT
- Status last verified
- Feb 2023
- First submitted
- 18 Apr 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Novel Methods of Study Information Notice Administration to the Standard Approach in Enhancing Clinical Studies Understanding in Resource Limited Settings: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05341791
- Acronym / sponsor ID
- CONSENT / EG0266
- Conditions
- Information Disclosure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized trial in which participants are assigned to one of 2 strategies of information notice administration which include the standard approach versus a video-based cartoon approach. An information notice about the study will be administered to each participant individually. The study involves the integration of tuberculosis screening at all pediatric entry points, and other activities aimed at improving pediatric tuberculosis diagnosis and management. The understanding of participants will be assessed using a test of understanding adapted from the Quality of Informed consent (QIC).
Detailed description
Objectives:
Primary Objective: is to evaluate the effectiveness of cartoon video-based study information notice administration compared to standard study information notice administration as assessed by the QIC Secondary Objectives: - Determine the factors associated with effectiveness of the cartoon video-based study information notice administration.
Endpoints:
Primary Endpoint: The proportion of participants scoring more than 80% at the test of understanding, comparing the novel and the standard strategy.
Study Population: Our population will consist of adults bringing their children for routine care in the facilities in which the study will be conducted.
Study Sites This study will be conducted in 4 sites located in the West, Littoral and Center regions of Cameroon. These sites are the District Hospital of Dschang, the district hospital of Foumban, the District hospital of Loum, and the district hospital of Soa. These sites are semi-urban sites and are selected to facilitate inclusion of participants from urban, peri-urban and rural settings. Also, these sites conduct routine systematic and active screening for pediatric tuberculosis of all children presenting for care in the facility, as well as other interventions to improve pediatric tuberculosis diagnosis and management. These tuberculosis activities, which had been implemented by EGPAF through the CaP TB program are now part of the routine sites activities and will be used to build the information notice for the purpose of this study.
Participant's eligibility and recruitment process Eligible participants will be adults (of at least 21 years of age), or emancipated minors bringing their children (of less than 15 years) for routine care in the selected facilities, and able to read and write English or French and who accept to be part of the study. Every day, routine triage registers (and/or immunization registers, depending on the organization of the health facility) will be used to identify parents bringing their children for routine care. Parents whose children have a serial number in the register which is a multiple of 3 will be screened for eligibility to the study and enrolled if eligible and after providing a written consent. A maximum of 10 participants will be enrolled per day. All enrolled participants will be randomly allocated to the intervention arm (video-cartoon) or to standard consenting following a 1:1 ratio.
Description of the information notice to be administered An information notice on the integration of tuberculosis activities at all pediatric entry points will be developed. This information notice will include details on definition of tuberculosis, rationale and process of systematic and active screening for tuberculosis at all pediatric entry points, sample collection and chest X-ray procedures and indications, data collected as part of the TB activities in the sites, risks and benefits of TB screening and diagnosis procedures, and possibility to accept or refuse TB procedures.
Description of Study arms:
There are 2 study arms. The standard administration of information notice consists of a paper-based study information notice which is provided to the participant during a one-to-one conversation with a study staff. The participant either reads the study information notice or it is read to him/her and explained section by section. The video-based study information notice administration consists of a 20 minutes' cartoon video explaining the study which will be played to the participant.
Study Duration: 20 months
Participant Duration in the study: 1 day
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard administration of information notice | No intervention | –: During the standard study information administration, the participant will read though the written information notice which will be organized in sections. After each section, the study staff will explain to the participant the key information to understand. Throughout the process, participants will be allowed to ask study staff questions. We anticipate the time to administer consent by this standard approach will be approximately 45 to 60 minutes per participants. |
| video administration of information notice | Experimental | Other: Cartoon video describing study information noticeThe video will be 20-minutes long, and will consist of graphic depictions (in cartoon style) of the study information content presented in the same flow as the written notice, and explained by a voice-over in the background. The participant will view the video in a quiet room, on a tablet provided by the study staff. The participant will be able to pause the video or rewind it as needed, and view it at his/her desired pace. The video will have an embedded knowledge check at the end of each section, consisting of a background voice asking some questions, pausing (for the participant to think through the correct answers) and then providing the right answers. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All adults > = 21 years of age, or emancipated minors (persons between 15-17 years who are married or pregnant/have children or head of a household)
- Are able to speak, read and write English or French
- Bringing their children for routine consultation or immunization in the selected study sites
- Give their written consent to take part to the study
Key exclusion criteria (1 listed)
- Participants with visual or hearing challenges which prevent them from reading written forms or viewing/listening to a video content will be excluded Selection of participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cartoon video describing study information noticeThe video will be 20-minutes long, and will consist of graphic depictions (in cartoon style) of the study information content presented in the same flow as the written notice, and explained by a voice-over in the background. The participant will view the video in a quiet room, on a tablet provided by the study staff. The participant will be able to pause the video or rewind it as needed, and view it at his/her desired pace. The video will have an embedded knowledge check at the end of each section, consisting of a background voice asking some questions, pausing (for the participant to think through the correct answers) and then providing the right answers. | Other | video administration of information notice |
Primary outcome
The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy.
Time frame: 1 day
The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris K Tchounga, MD, PhD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cartoon video describing study information notice in people with Information Disclosure, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.