- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04700462
COVID-19 Preventive Behavior in African Americans
2 november 2021 uppdaterad av: Johns Hopkins University
Optimizing Tailored-feedback Message to Promote Adherence Behavior to Prevent COVID-19 in African Americans
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
250
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Maryland
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Baltimore, Maryland, Förenta staterna, 21205
- Johns Hopkins School of Nursing
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Sm-EMA
Participants will receive the Self-monitoring ecological momentary assessment behavior change tool.
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Self-monitoring ecological momentary assessment behavior change tool to promote adherence to a desired behavior (i.e.
COVID-19 preventative behaviors).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Knowledge Test score as assessed by a questionnaire
Tidsram: 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.
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Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
Change in Self-efficacy as assessed by self-efficacy questionnaire
Tidsram: 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.
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Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
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Change in preventive Behavior Score
Tidsram: 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.
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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
Tidsram: Immediately Post-intervention
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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.
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Immediately Post-intervention
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Change in Global Impression of Change as assessed by a questionnaire
Tidsram: Immediately Post-intervention, 1, 2, and 3 months Post-intervention
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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.
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Immediately Post-intervention, 1, 2, and 3 months Post-intervention
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Chao Hsing Yeh, PhD, Johns Hopkins School of Nursing
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 februari 2021
Primärt slutförande (Faktisk)
30 oktober 2021
Avslutad studie (Faktisk)
30 oktober 2021
Studieregistreringsdatum
Först inskickad
6 januari 2021
Först inskickad som uppfyllde QC-kriterierna
6 januari 2021
Första postat (Faktisk)
7 januari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 november 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 november 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00250644
- 3R01AG056587-03S1 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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