COVID-19 Preventive Behavior in African Americans
2 novembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
250
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Maryland
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Baltimore, Maryland, États-Unis, 21205
- Johns Hopkins School of Nursing
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Knowledge Test score as assessed by a questionnaire
Délai: 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
|
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Change in Self-efficacy as assessed by self-efficacy questionnaire
Délai: 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.
|
Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
|
Change in preventive Behavior Score
Délai: 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
|
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Change in System Usability Scale (SUS) score
Délai: 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.
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Immediately Post-intervention
|
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Change in Global Impression of Change as assessed by a questionnaire
Délai: 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.
|
Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Chao Hsing Yeh, PhD, Johns Hopkins School of Nursing
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
5 février 2021
Achèvement primaire (Réel)
30 octobre 2021
Achèvement de l'étude (Réel)
30 octobre 2021
Dates d'inscription aux études
Première soumission
6 janvier 2021
Première soumission répondant aux critères de contrôle qualité
6 janvier 2021
Première publication (Réel)
7 janvier 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 novembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 novembre 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00250644
- 3R01AG056587-03S1 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .