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COVID-19 Preventive Behavior in African Americans

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ClinicalTrials.gov Identifier: NCT04700462
Recruitment Status : Not yet recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Covid19 Health Behavior Behavioral: Sm-EMA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing Tailored-feedback Message to Promote Adherence Behavior to Prevent COVID-19 in African Americans
Estimated Study Start Date : January 20, 2021
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sm-EMA
Participants will receive the Self-monitoring ecological momentary assessment behavior change tool.
Behavioral: Sm-EMA
Self-monitoring ecological momentary assessment behavior change tool to promote adherence to a desired behavior (i.e. COVID-19 preventative behaviors).




Primary Outcome Measures :
  1. Change in Knowledge Test score as assessed by a questionnaire [ Time Frame: Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention ]
    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.

  2. Change in Self-efficacy as assessed by self-efficacy questionnaire [ Time Frame: Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention ]
    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.

  3. Change in preventive Behavior Score [ 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 ]
    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.

  4. Change in System Usability Scale (SUS) score [ Time Frame: Immediately Post-intervention ]
    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.

  5. Change in Global Impression of Change as assessed by a questionnaire [ Time Frame: Immediately Post-intervention, 1, 2, and 3 months Post-intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700462


Contacts
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Contact: Chao Hsing Yeh, PhD 667-208-7637 cyeh13@jhu.edu
Contact: Catherine Ling, PhD cling11@jhu.edu

Sponsors and Collaborators
Johns Hopkins University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Chao Hsing Yeh, PhD Johns Hopkins School of Nursing
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04700462    
Other Study ID Numbers: IRB00250644
3R01AG056587-03S1 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
COVID-19
Smartphone App
Preventative Behavior
Self-Management
Health Disparities