COVID-19 Preventive Behavior in African Americans

Covid19 Clinical Trial

Official title:

Optimizing Tailored-feedback Message to Promote Adherence Behavior to Prevent COVID-19 in African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700462
• Other study ID #: IRB00250644
• Secondary ID: 3R01AG056587-03S
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: January 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Center Disease Control has published a set of guidelines to contain the spread of the virus, since it is known to spread from person-to-person. Given the vaccine and specific antiviral treatment for Coronavirus disease (COVID-19) remain under development and will take months or years to develop, intermittent and sustained preventive behaviors may be needed into 2022 unless effective treatments or vaccines are developed. Thus, effectively implementing preventive behaviors remains a critical step in bringing the pandemic under long-term control. Leveraging the ecological momentary assessment (EMA) method developed in the parent R01 for smartphones, which allows for real-time data collection on individual's behaviors, the investigators propose a prospective single arm and longitudinal study to examine the effectiveness of self-monitoring EMA (SM-EMA) in promoting adherence to COVID-19 preventative behaviors. SM-EMA users will download the smartphone app which includes: (1) instructional videos to provide knowledge of preventative behaviors; (2) self-monitoring of preventative behaviors during intervention and follow-up phases; (3) tailored-feedback messages to encourage preventative behaviors; and (4) mobile-enabled website to provide an interactive learning platform. If proven efficacious, this intervention could be efficiently disseminated to reach the larger public and foster preventive behaviors into self-management as effective strategies for long-term control of the COVID-19 pandemic.

Description:

Given the vaccine and specific antiviral treatment for COVID-19 will take months or years to develop and finalize, preventive behaviors remain the most effective strategy thus far and may be needed until 2022 to control the pandemic. African Americans, who have 3-fold higher infection rate and 6-fold higher death rate compared to the white counterparts, are an especially vulnerable population to COVID-19. Immediately initiating a project that promotes and maximizes adherence to preventative behaviors is vital to addressing the ongoing COVID-19 pandemic. The investigators propose a prospective single arm and longitudinal study to examine the effectiveness of SM-EMA in promoting adherence to COVID-19 preventative behaviors. The intervention will include two daily pop-up messages during Week 1 (one in the morning and one in the afternoon), one daily pop-message in Week 2, and two pop-up messages a week in Weeks 3 and 4. The duration for the intervention will be four weeks. The study outcomes will be collected at baseline (pre-intervention, T1), post-(completion of the intervention, T2, primary endpoint), and monthly follow-up for three months (T3-T5). The total study duration will be four months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• African American aged 60 or older

• Able to read and write English

• Willing to commit to use the smartphone app with the pop-up messages and then four follow-up surveys (total four months).

Exclusion Criteria:

• No children or others aged 59 years or younger

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Health Behavior

Intervention

Behavioral:
• Sm-EMA
Self-monitoring ecological momentary assessment behavior change tool to promote adherence to a desired behavior (i.e. COVID-19 preventative behaviors).

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knowledge Test score as assessed by a questionnaire	It is a measure of one's knowledge of COVID-19 preventative behaviors, with a score range of 0-18, higher scores indicating better knowledge.	Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
Primary	Change in Self-efficacy as assessed by self-efficacy questionnaire	It is a measure of one's belief that they will be successful in reaching a behavior goal, with 6-items of questionnaire, with a score of 0-60, higher score indicating higher level of self-efficacy.	Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
Primary	Change in preventive Behavior Score	It is a measure of one's adherence to COVID-19 preventative behaviors, with a score range 0-18, higher score indicating worsening preventive behaviors.	Pre-intervention, Daily during intervention week 1 and bi-weekly during intervention weeks 3-4, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
Primary	Change in System Usability Scale (SUS) score	It is used to assess the global view of the participant's assessment about usability of SM-EMA, with a score of 1-7, higher score indicting more useable for the app.	Immediately Post-intervention
Primary	Change in Global Impression of Change as assessed by a questionnaire	It is a single item used to assess the participant's perceived behavior change, with a score of 1-7, higher score indicating better global impression of change.	Immediately Post-intervention, 1, 2, and 3 months Post-intervention