Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT07021716
Brief Summary:
Knowledge, attitudes, behaviors and perceived risk highlight the importance of education translated into actions to reduce the risk of global infections. The purpose was to investigate the knowledge, attitudes and practices (KAP), and perceived risk associated with COVID-19 among patients with multiple sclerosis (MS), healthcare providers and laypeople during the first 6-months of the pandemic. A descriptive, cross-sectional, partially mixed-methods explanatory sequential design was employed, using convenience sampling. Data were collected through a demographic and a KAP questionnaires including perceived risk assessment. Quantitative data were analyzed with descriptive and inferential statistics, while qualitative comments underwent thematic analysis.
Detailed Description:
This is a descriptive cross-sectional, partially mixed method explanatory sequential study, following the Good Reporting of A Mixed Methods Study (GRAMMS) guideline. This study concentrated on the KAP of patients with MS, healthcare professionals and lay people. The aim was to explain the quantitative survey results with qualitative themes in an explanatory sequential design. The goal of the quantitative phase was to examine the COVID-19-related knowledge, attitudes, and practices among healthcare professionals, laypeople, and patients with multiple sclerosis (MS) during the first 6 months of the pandemic and to compare the perceived risk of coronavirus infection across these three groups. The goal of the qualitative phase of this study was to identify and analyze the emergent themes reflecting participants' perceptions of their risk related to COVID-19. The goal of the mixed methods phase was to generate integrated support for the participants knowledge, attitudes, practices, and perceived risk based upon quantitative and qualitative evidence.
Theoretical Framework. The knowledge-attitude-behavior (KAB) model considers that knowledge and information gained are fundamental prerequisite for behavioral changes. People are able to gain knowledge and practical skills through education. Accordingly, professionals, laypeople, and patients need to learn and get basic and advanced knowledge, which can lead to the growth of positive beliefs and attitudes that are fortified with the acceptance of healthy behaviors (Liu et al., 2016; Zulkifli et al., 2022). Furthermore, the KAB framework highlights the relationship between knowledge, attitudes and behaviors and their influence on actions (Maleki et al., 2020).
Instruments. The KAP questionnaire consisted of a demographic form, and a KAP questionnaire. The prequestionnaire solicited basic demographic information such as the participant's age, gender, education level, and patients' disease related information. The KAP instrument was adapted from the CDC (CDC; CDC Center for Disease Control; Maike WintersComments to Author 2017) and used with permission. The KAP survey instrument has been used nationally and internationally to explore people's health behaviors and their lifestyle changes (Azlan et al., 2020; CDC; Masoud et al., 2021; Qalati et al., 2023; Zhong et al., 2020). The survey included 50 close-ended questions that took 20-25 minutes to complete. It covered demographics (10 items), COVID-19 knowledge (15 items), attitudes (17 items), and practices (8 items). True/false questions had "I don't know" and "declined to answer" options, with responses categorized as correct or incorrect (Seninde \& Chambers, 2021; Smyth et al., 2006). Open-ended questions were analyzed to assess the participants' perceptions qualitatively.
Perceived risk for contracting COVID-19 was assessed using a 5-point scale (0=no risk at all, 1=a small risk, 2=a moderate risk, 3=a high risk, 4=Don't know). Perceived risk of COVID was assessed as a categorical variable. It was analyzed as dichotomous variable (low risk vs. moderate/high risk) and as 4-categorical variable (low risk, moderate risk, high risk and don't know). Perceived risk was assessed and analyzed in each group, patients with MS, healthcare professionals and lay people.
Data Collection. The population for this study included healthcare professionals (nurses and physicians), patients with MS, and lay people from the northeast region in the USA. It included participants from New York, Connecticut and Massachusetts. A convenience sampling approach was used to enhance recruitment. The participants were recruited via blast emails through health centers, MS centers, and community resources. Data were collected via an online self-reported questionnaire from April 2020 to September 2020. The surveys were completed online via anonymous and confidential software, i.e., a 'Monkey' survey. The inclusion criteria of the study included adult people (≥18 years), consisting of patients with MS, healthcare professionals (nurses and physicians), and adult lay people. The project did not include any exclusion criteria.
Data Analysis. Descriptive analyses were used to characterize the sample. Chi-square and Kruskal Wallis tests assessed associations between demographics, KAPs, and perceived risk. Kruskal Wallis test compared KAP across patients with MS, healthcare professionals, and laypeople. Logistic regression assessed the perceived risk as a dependent dichotomized variable (low and moderate/high risk), immunocompromised state or vaccination hesitancy as independent variables controlling for age, sex, and education. Statistical significance was set at p\<.05. A qualitative thematic analysis was performed and coded on participants' comments by two researchers (AB and JS) to identify key themes reaching data saturation.
Study:
NCT07021716
Study Brief:
Protocol Section:
NCT07021716