- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05039528
Design og brukervennlighetstesting av en skreddersydd intervensjon om søvn- og søvnforstyrrelser blant transportarbeidere
Design og brukervennlighetstesting av en skreddersydd intervensjon for å øke bevisstheten om søvn- og søvnforstyrrelser blant transportarbeidere
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Placebo komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Obstructive Sleep Apnea (OSA) Self-efficacy
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
OSA Knowledge
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Rebecca Robbins, PhD, Brigham and Women's Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019P003171
- K01HL150339 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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