COVID-19 Preventive Behavior in African Americans

NCT04700462 | Completed DMC

• 2 other identifiers: IRB002506443R01AG056587-03S1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Health Behavior

Keywords

COVID-19; Smartphone App; Preventative Behavior; Self-Management; Health Disparities

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Sm-EMA

EXPERIMENTAL

Participants will receive the Self-monitoring ecological momentary assessment behavior change tool.

Behavioral: Sm-EMA

Interventions

Sm-EMA BEHAVIORAL

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

Sm-EMA

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• No children or others aged 59 years or younger

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

COVID-19; Health Behavior

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Chao Hsing Yeh, PhD

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: February 5, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-01

Locations

US (1)