COVID-19 Preventive Behavior in African Americans
Primary Purpose
Covid19, Health Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sm-EMA
Sponsored by

About this trial
This is an interventional prevention trial for Covid19 focused on measuring COVID-19, Smartphone App, Preventative Behavior, Self-Management, Health Disparities
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
Sites / Locations
- Johns Hopkins School of Nursing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sm-EMA
Arm Description
Participants will receive the Self-monitoring ecological momentary assessment behavior change tool.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04700462
First Posted
January 6, 2021
Last Updated
November 2, 2021
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04700462
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Health Behavior
Keywords
COVID-19, Smartphone App, Preventative Behavior, Self-Management, Health Disparities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sm-EMA
Arm Type
Experimental
Arm Description
Participants will receive the Self-monitoring ecological momentary assessment behavior change tool.
Intervention Type
Behavioral
Intervention Name(s)
Sm-EMA
Intervention Description
Self-monitoring ecological momentary assessment behavior change tool to promote adherence to a desired behavior (i.e. COVID-19 preventative behaviors).
Primary Outcome Measure Information:
Title
Change in Knowledge Test score as assessed by a questionnaire
Description
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.
Time Frame
Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
Title
Change in Self-efficacy as assessed by self-efficacy questionnaire
Description
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.
Time Frame
Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
Title
Change in preventive Behavior Score
Description
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.
Time Frame
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
Title
Change in System Usability Scale (SUS) score
Description
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.
Time Frame
Immediately Post-intervention
Title
Change in Global Impression of Change as assessed by a questionnaire
Description
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.
Time Frame
Immediately Post-intervention, 1, 2, and 3 months Post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao Hsing Yeh, PhD
Organizational Affiliation
Johns Hopkins School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
COVID-19 Preventive Behavior in African Americans
We'll reach out to this number within 24 hrs