Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT07262918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Medical TV Drama in Improving Literacy on Asthma
Sponsor:
Cephas Health Research Initiative Inc, Ibadan, Nigeria
Organization:
Study Overview
Official Title:
The Impact of Medical TV Drama in Improving Literacy on Asthma: An Online Open-Label Two-arm Randomized Control Trial.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asthma is an important chronic noncommunicable disease that affects children and adults following a complex immune-mediated mechanism involving airway inflammation, bronchial hyperresponsiveness, and transient and intermittent airway obstruction. A current global empirical study, published in 2025, estimated that asthma affects about 260 million people, and it is responsible for about 455,000 deaths globally. Despite the morbidity and mortality-laden nature of asthma, the awareness and knowledge of this important condition remains low among several populations. Notably, no known multi-country intervention study has ever investigated the effectiveness, acceptability, and usability of medical TV programs in educating young persons on asthma. Therefore, this two-arm randomized control trial (RCT) aims to evaluate the impact of watching a medical TV drama on asthma among a sample of individuals (who do not have prior medical knowledge) from different cultural backgrounds and countries.
Detailed Description:
Asthma is an important chronic noncommunicable disease that affects children and adults following a complex immune-mediated mechanism involving airway inflammation, bronchial hyperresponsiveness, and transient and intermittent airway obstruction. Asthma is the most common chronic disease in childhood. A current global empirical study, published in 2025, estimated that asthma affects about 260 million people, and it is responsible for about 455,000 deaths globally. Despite the morbidity and mortality-laden nature of asthma, the awareness and knowledge of this important condition remains low among several populations. This knowledge gap can cause poor adherence to treatment. Studies have shown that media entertainment is a potent tool that can be used to deliver complex health information for a desired behavioral change among young people. Therefore, this two-arm randomized control trial (RCT) aims to evaluate the impact of watching a medical TV drama on asthma among a sample of individuals (who do not have prior medical knowledge) from different cultural backgrounds and countries. The insights gained from this online two-arm RCT will contribute to existing knowledge on the area of asthma prevention and control, and it will help to direct policy recommendations for planning health education interventions targeted at young adults.
METHODS Study Design This study will be an online, open-label, parallel-group, two-arm RCT, a rigorous design widely used to evaluate the effectiveness of health interventions. The trial will aim to determine the impact of a medical TV drama episode on asthma-related health literacy among young adults. The design will be informed by evidence suggesting that entertainment media can enhance health knowledge and influence behavior change. Participants will be randomly assigned to either an intervention group (who will view the episode) or a control group (with no exposure), and their knowledge scores will be compared before and after the intervention. The study will follow the CONSORT (Consolidated Standards of Reporting Trials) 2010 guidelines for the reporting of RCTs.
Study Setting and Participants. The trial will be conducted entirely online, a delivery model increasingly adopted for its cost-efficiency, accessibility, and potential to reach a geographically diverse population. Participants will be recruited using social media platforms such as Facebook, Instagram, WhatsApp, and X (formerly Twitter), which have previously been shown to be effective for digital recruitment in health research.
Only those who provide consent will be enrolled in the study, in accordance with ethical guidelines for digital health research.
Sample Size Determination The sample size will be calculated using G\*Power version 3.1, a well-established tool for statistical power analysis. Assuming a two-tailed independent samples t-test, an alpha level of 0.05, a power of 0.80, and a large effect size (Cohen's d = 0.83), the minimum required sample size will be 48 participants, with 24 participants per group. This sample size will provide sufficient power to detect large differences in asthma-related knowledge outcomes.
Randomization and Allocation Following informed consent, participants will be randomly assigned in a 1:1 ratio to either the intervention or control group. Randomization will be executed manually using a balloting technique, ensuring equal allocation and minimizing allocation bias. Due to the visible nature of the media intervention, participant blinding will not be possible, and the study will therefore adopt an open-label design.
Intervention Participants in the intervention arm will be asked to watch House M.D., Season 1, Episode 1, which includes dramatized depictions of asthma-related clinical scenarios. Prior research has demonstrated that medical TV dramas can enhance viewers' health literacy and influence decision-making, particularly in younger audiences. After viewing the episode, participants will complete a structured post-test questionnaire.
Participants in the control group will complete the same questionnaire at the same time intervals but will not view the media intervention. No additional educational content will be provided to either group during the study period.
Study Instruments The study instruments that will be used in this RCT are a pre-test and a post-test questionnaire. Both questionnaires will obtain, inter alia, data on the sociodemographic characteristics of the participants and their knowledge of asthma.
To ensure content validity, the initial draft of the questionnaire will be reviewed by two clinical experts in respiratory medicine. A pilot test involving five individuals (meeting the inclusion criteria but excluded from the trial) will be conducted to evaluate clarity, comprehension, and administration time. Feedback from the pilot will inform minor revisions to item structure and wording.
Participants in the intervention group will complete the questionnaire as a pre-test before viewing the episode and a post-test immediately afterward. Control group participants will complete the same questionnaire at matched time points without viewing the episode. Each correct answer will score one point, yielding a maximum score of 10. This outcome measure is focused exclusively on cognitive knowledge acquisition, and no secondary outcomes such as behavioral intent or media perception will be assessed.
Data will be collected using encrypted digital forms via Google Forms®. All responses will be time-stamped and automatically stored on password-protected institutional servers accessible only to the research team. Responses with more than 20% missing data will be excluded from analysis to ensure quality. Additional quality control procedures will include screening for contradictory answers, unusually fast completion times (e.g., under one minute), and potential duplicate submissions identified via IP and timestamp monitoring.
Statistical Analysis Descriptive statistics, including means, standard deviations, and frequencies, will be used to summarize participant demographics and outcome data. For inferential analysis, paired t-tests will be applied to assess within-group changes in knowledge scores (pre- vs. post-test), while independent samples t-tests will compare changes between the intervention and control groups. The Shapiro-Wilk test will be used to evaluate the normality of score distributions. When normality assumptions are violated, appropriate non-parametric tests such as the Wilcoxon signed-rank test and Mann-Whitney U test will be used. A p-value \< 0.05 will be considered statistically significant.
Ethical Considerations Ethical approval has been obtained from the Institutional Review Board of Caleb University, Nigeria (CUL 25/0877). All participants will provide electronic informed consent before enrolment. They will be informed of their right to withdraw from the study at any time without penalty. All procedures will comply with international ethical standards for digital research involving human subjects.
Trial Timeline Participant recruitment and pre-test will be done in Weeks 2 and 3. The intervention will be administered in Week 4, and post-test will be done in Weeks 8 to 9. Data cleaning and analysis were conducted in Weeks 10 and 11, and the results will be compiled and disseminated in Weeks 12 to 16.
METHODS Study Design This study will be an online, open-label, parallel-group, two-arm RCT, a rigorous design widely used to evaluate the effectiveness of health interventions. The trial will aim to determine the impact of a medical TV drama episode on asthma-related health literacy among young adults. The design will be informed by evidence suggesting that entertainment media can enhance health knowledge and influence behavior change. Participants will be randomly assigned to either an intervention group (who will view the episode) or a control group (with no exposure), and their knowledge scores will be compared before and after the intervention. The study will follow the CONSORT (Consolidated Standards of Reporting Trials) 2010 guidelines for the reporting of RCTs.
Study Setting and Participants. The trial will be conducted entirely online, a delivery model increasingly adopted for its cost-efficiency, accessibility, and potential to reach a geographically diverse population. Participants will be recruited using social media platforms such as Facebook, Instagram, WhatsApp, and X (formerly Twitter), which have previously been shown to be effective for digital recruitment in health research.
Only those who provide consent will be enrolled in the study, in accordance with ethical guidelines for digital health research.
Sample Size Determination The sample size will be calculated using G\*Power version 3.1, a well-established tool for statistical power analysis. Assuming a two-tailed independent samples t-test, an alpha level of 0.05, a power of 0.80, and a large effect size (Cohen's d = 0.83), the minimum required sample size will be 48 participants, with 24 participants per group. This sample size will provide sufficient power to detect large differences in asthma-related knowledge outcomes.
Randomization and Allocation Following informed consent, participants will be randomly assigned in a 1:1 ratio to either the intervention or control group. Randomization will be executed manually using a balloting technique, ensuring equal allocation and minimizing allocation bias. Due to the visible nature of the media intervention, participant blinding will not be possible, and the study will therefore adopt an open-label design.
Intervention Participants in the intervention arm will be asked to watch House M.D., Season 1, Episode 1, which includes dramatized depictions of asthma-related clinical scenarios. Prior research has demonstrated that medical TV dramas can enhance viewers' health literacy and influence decision-making, particularly in younger audiences. After viewing the episode, participants will complete a structured post-test questionnaire.
Participants in the control group will complete the same questionnaire at the same time intervals but will not view the media intervention. No additional educational content will be provided to either group during the study period.
Study Instruments The study instruments that will be used in this RCT are a pre-test and a post-test questionnaire. Both questionnaires will obtain, inter alia, data on the sociodemographic characteristics of the participants and their knowledge of asthma.
To ensure content validity, the initial draft of the questionnaire will be reviewed by two clinical experts in respiratory medicine. A pilot test involving five individuals (meeting the inclusion criteria but excluded from the trial) will be conducted to evaluate clarity, comprehension, and administration time. Feedback from the pilot will inform minor revisions to item structure and wording.
Participants in the intervention group will complete the questionnaire as a pre-test before viewing the episode and a post-test immediately afterward. Control group participants will complete the same questionnaire at matched time points without viewing the episode. Each correct answer will score one point, yielding a maximum score of 10. This outcome measure is focused exclusively on cognitive knowledge acquisition, and no secondary outcomes such as behavioral intent or media perception will be assessed.
Data will be collected using encrypted digital forms via Google Forms®. All responses will be time-stamped and automatically stored on password-protected institutional servers accessible only to the research team. Responses with more than 20% missing data will be excluded from analysis to ensure quality. Additional quality control procedures will include screening for contradictory answers, unusually fast completion times (e.g., under one minute), and potential duplicate submissions identified via IP and timestamp monitoring.
Statistical Analysis Descriptive statistics, including means, standard deviations, and frequencies, will be used to summarize participant demographics and outcome data. For inferential analysis, paired t-tests will be applied to assess within-group changes in knowledge scores (pre- vs. post-test), while independent samples t-tests will compare changes between the intervention and control groups. The Shapiro-Wilk test will be used to evaluate the normality of score distributions. When normality assumptions are violated, appropriate non-parametric tests such as the Wilcoxon signed-rank test and Mann-Whitney U test will be used. A p-value \< 0.05 will be considered statistically significant.
Ethical Considerations Ethical approval has been obtained from the Institutional Review Board of Caleb University, Nigeria (CUL 25/0877). All participants will provide electronic informed consent before enrolment. They will be informed of their right to withdraw from the study at any time without penalty. All procedures will comply with international ethical standards for digital research involving human subjects.
Trial Timeline Participant recruitment and pre-test will be done in Weeks 2 and 3. The intervention will be administered in Week 4, and post-test will be done in Weeks 8 to 9. Data cleaning and analysis were conducted in Weeks 10 and 11, and the results will be compiled and disseminated in Weeks 12 to 16.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: