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- Essai clinique NCT05039528
Conception et test d'utilisabilité d'une intervention sur mesure concernant le sommeil et les troubles du sommeil chez les travailleurs des transports
Conception et test d'utilisabilité d'une intervention sur mesure pour accroître la sensibilisation au sommeil et aux troubles du sommeil chez les travailleurs des transports
The objective of this protocol is to conduct a focus group to identify OSA beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Transportation shift workers (TSW, e.g., overnight, on-call, or rotating) have been identified as a high-risk group for health conditions (e.g., obesity, cardiovascular disease). Also, TSW are at risk for obstructive sleep apnea (OSA). According to one study, approximately 36% of TSWs have OSA, a condition that exacerbates health risks and daytime sleepiness. A recent report from the American Academy of Sleep Medicine (AASM) showed that those with untreated OSA cost on average $4,261 more than those without OSA. Also concerning, workers with OSA who are non-adherent to recommended OSA treatment (i.e., continuous positive airway pressure, CPAP) are at particularly high risk for motor vehicle accidents compared to those who are adherent.
This protocol outlines focus groups that will aim to identify knowledge, attitudes, and beliefs about OSA among TSW. Results of these focus groups will be used in future research to design a tailored website for relaying OSA information to TSW.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18 years or older
- Access to a smartphone device
- Commitment to completing all study activities
- Score 4 or higher (mild or higher on OSA risk) according to the Apnea Risk Evaluation System (ARES) questionnaire.
Exclusion Criteria:
- Significant medical or psychiatric illness according to the PROMIS Short Form (SF-12)
- No OSA risk (a score below 4 on the ARES).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
Participants will receive the personalized OSA messages. |
Participants will receive personalized OSA messages designed to nudge and navigate them toward evaluation and treatment for OSA. Participants will complete questionnaires at baseline and at study follow-up. |
|
Comparateur placebo: Control
Placebo participants will receive no treatment during the experiment. |
Participants will complete questionnaires at baseline and at study follow-up. At the end of the study period, participants will receive the OSA message intervention. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Obstructive Sleep Apnea (OSA) Self-efficacy
Délai: Baseline and follow-up (approximately 2 months)
|
The Survey of Obstructive Sleep Apnea Functional Health Literacy (SOFHL) was administered, which includes two subscales, one for OSA Self-Efficacy and another for OSA Knowledge. The SOFHL can be scored by measuring the proportion of correct answers in each sub-scale (OSA Self-Efficacy and OSA Knowledge). The OSA Self-Efficacy subscale collects responses to 5 self-efficacy questions on 3-point scales from 1 "I am confident" to 2 "I am not sure" and 3 "I am not confident." Scores of 1 ("I am confident") indicate self-efficacy. To score OSA Self-Efficacy, the total number of questions that participants mark a response of "1" ("I am confident") are summed then divided by the total number of questions in the subscale (5) and multiplied by 100. The result is a total score with a minimum possible value of 0% and a maximum possible value of 100%. Lower scores (closer to 0%) indicate low OSA self-efficacy scores. Higher scores (closer to 100%) indicate higher OSA Self-efficacy. |
Baseline and follow-up (approximately 2 months)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
OSA Knowledge
Délai: Baseline and follow-up (approximately 2 months)
|
The Survey of Obstructive Sleep Apnea Functional Health Literacy (SOFHL) was administered, which includes two subscales, one for OSA Self-Efficacy and another for OSA Knowledge. The SOFHL can be scored by measuring the proportion of correct answers in each sub-scale (OSA Self-Efficacy and OSA Knowledge). The OSA Knowledge subscale collects responses to 13 knowledge questions on 3-point scale from 1 ("I am confident this is true") to 2 ("I am not sure") and 3 ("I am confident this is not true"). To score OSA Knowledge, the total number of responses of 1 "I am confident this is true" are summed then divided by 13 and multiplied by 100. The result is a score with a minimum possible value of 0% and a maximum possible value of 100%. Lower scores (closer to 0%) indicate lower OSA knowledge while higher scores (closer to 100%) indicate higher OSA Knowledge. |
Baseline and follow-up (approximately 2 months)
|
|
OSA Readiness to Change
Délai: Baseline and follow-up (approximately 2 months)
|
OSA Readiness to Change: A measure of willingness to improve sleep and address sleep problems. OSA readiness to change will be measured with a 12-item questionnaire. Responses are captured on a 5-item scale from 1 "strongly disagree" to 5 "strongly agree." Responses are summed for a total score of readiness to change. Higher scores indicate higher levels of readiness to change. |
Baseline and follow-up (approximately 2 months)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rebecca Robbins, PhD, Brigham and Women's Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2019P003171
- K01HL150339 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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