Clinical trial NCT04700462: COVID-19 Preventive Behavior in African Americans
Official title: Optimizing Tailored-feedback Message to Promote Adherence Behavior to Prevent COVID-19 in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Health Behavior
Keywords: COVID-19
Smartphone App
Preventative Behavior
Self-Management
Health Disparities
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-01-07
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Knowledge Test score as assessed by a questionnaire
timeFrame: Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
measure: Change in Self-efficacy as assessed by self-efficacy questionnaire
timeFrame: Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
measure: Change in preventive Behavior Score
timeFrame: 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
measure: Change in System Usability Scale (SUS) score
timeFrame: Immediately Post-intervention
measure: Change in Global Impression of Change as assessed by a questionnaire
timeFrame: Immediately Post-intervention, 1, 2, and 3 months Post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Chao Hsing Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
References: