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Sleep Quality in High School Students With Asthma

3. mars 2021 oppdatert av: Jean-Marie Bruzzese, Columbia University

A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma

The overall goal of this project is to develop and to preliminarily validate a novel intervention to be delivered in the high school setting that integrates two evidence-based, school-based interventions for urban adolescents with proven efficacy: (1) Asthma Self-Management for Adolescents (ASMA), an intervention for adolescents with uncontrolled asthma and (2) the Sleep-Smart Program (Sleep-Smart), which focuses on sleep hygiene and behaviors in urban adolescents.

The aim for Phase I is to develop and integrate school-based interventions to improve asthma self-management and sleep hygiene in urban high school students via interviews.

The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the intervention procedures; and (2) to assess the preliminary evidence of the effects of the intervention on improving sleep quality in urban high school students with persistent asthma over a 2-month follow-up period.

This record is for Phase I only.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Sleep quality among adolescents is poor and asthma's impact is significant among adolescents. Asthma control is an important risk factor for poor sleep and poor academic performance. In addition, poor asthma control, poor sleep hygiene, and poor sleep quality are more likely in urban settings. Interventions to promote sleep quality by targeting both asthma control and sleep hygiene in this vulnerable population are lacking.

To adapt ASMA and Sleep-Smart, the investigators will use a 3-step iterative process that will consist of (1) interviewing high school students and their caregivers, (2) interviewing high school teachers and (3) conducting separate focus groups with students and caregivers. The investigators hypothesize that the intervention will be feasible and acceptable. This study is a multi-site trial and collaboration between Columbia University Medical Center and Rhode Island Hospital (RIH).

Studietype

Observasjonsmessig

Registrering (Faktiske)

36

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • New York
      • New York, New York, Forente stater, 10032
        • Columbia University
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Rhode Island Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Families for Steps 1 and 3 will be identified through schools, clinics, and non-profit agencies that focus on asthma (e.g., American Lung Association). School principals, clinic directors, administrators and/or clinicians will distribute a flyer to families advertising the study, and families will be asked to call the researchers. In Rhode Island, families will also be recruited from their lab's database of past referrals and past research participants. Interested families will be screened for study eligibility by trained study staff.

Each site will recruit two high school teachers for Step 2 from teachers known to the investigative team (convenient sample)

Beskrivelse

ADOLESCENT-CAREGIVER DYADS (20 adolescents with persistent asthma and poor sleep, and their caregivers - 10 in Step 1 and 10 in Step 3)

Inclusion Criteria:

  1. a prior asthma diagnosis in the prior 12 months;
  2. use of prescribed asthma medications;
  3. persistent asthma (defined as (i) daytime symptoms 3+ days a week, (ii) night awakenings 3+ nights per month, (iii) 2+ Emergency Department visits or (iv) 1+ hospitalization for asthma); and
  4. sleep duration < 8 hours

Exclusion Criteria:

  1. report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;
  2. A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;
  3. active immunotherapy;
  4. additional pulmonary disease; and
  5. significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses.

SCHOOL TEACHERS (4 high school teachers - 2 from New York and 2 from Rhode Island in Step 2)

Inclusion Criteria:

- Teach at the high school level.

Exclusion Criteria:

- Unwilling to participate in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Students: Step 1 Interviews
20 adolescents with uncontrolled asthma and poor sleep [10 from New York City (NYC); 10 from Rhode Island (RI)] will provide information regarding their asthma and sleep routines, and on what they would like to see in an intervention targeting co-morbid asthma and poor sleep.
Caregivers: Step 1 Interviews
The caregivers of the 20 adolescents in this step [10 from NYC; 10 from RI] will be asked to provide information regarding their teenager's asthma and sleep routines, and on what they would like to see in an intervention targeting co-morbid asthma and poor sleep.
Teachers: Step 2 Interviews
4 high school teachers, 2 from NYC and 2 from RI, will review the developed intervention. They will provide their opinions about the appropriateness of the teaching methods and literacy level for adolescents.
Students: Step 3 Focus Groups
20 adolescents with uncontrolled asthma and poor sleep [10 from NYC; 10 from RI] will review the intervention providing feedback on its appropriateness and utility.
Caregivers: Step 3 Focus Groups
The caregivers of the 20 adolescents in this step [10 from NYC; 10 from RI] will review the intervention providing feedback on its appropriateness and utility in small groups.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of subjects successfully completing the interview
Tidsramme: Up to 10 months
Subjects will be interviewed regarding their preference and opinions about adapted curriculum.
Up to 10 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Daphne Koinis-Mitchell, PhD, Rhode Island Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. april 2017

Primær fullføring (Faktiske)

10. april 2018

Studiet fullført (Faktiske)

10. april 2018

Datoer for studieregistrering

Først innsendt

22. februar 2017

Først innsendt som oppfylte QC-kriteriene

2. mars 2017

Først lagt ut (Faktiske)

8. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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