Tailored Intervention to Promote Positive Airway Pressure Adherence (SCIP-PA)
30. september 2016 oppdatert av: Amy M. Sawyer, Milton S. Hershey Medical Center
Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence
The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes.
Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly.
The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA.
The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates.
The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.
Studietype
Intervensjonell
Registrering (Faktiske)
118
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Pennsylvania
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Hershey, Pennsylvania, Forente stater, 17033
- Penn State Hershey Medical Center
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- males and females >/= 18 years of age
- newly diagnosed with apnea/hypopnea index >/= 10 events/hr
- CPAP naive
- able to read and speak English
Exclusion Criteria:
- previous diagnosis and/or treatment of OSA
- major new psychiatric diagnosis within 6 months of study enrollment
- require supplemental oxygen or bilevel positive airway pressure on CPAP titration polysomnogram
- diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb movements >/= 10 events/hr with arousal, central sleep apnea with >/= 5 central events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Tailored
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
|
Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment.
Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
Andre navn:
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Aktiv komparator: Usual care
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
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Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Nightly CPAP Use
Tidsramme: 1 week
|
Mean CPAP use, hrs/night
|
1 week
|
|
Nightly CPAP Use
Tidsramme: 1 month
|
Mean CPAP use, hrs/night
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1 month
|
|
Nightly CPAP Use
Tidsramme: 3 months
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Mean CPAP use, hrs/night
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3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Sleep Time on CPAP
Tidsramme: 1 week
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% of Total Sleep Time (TST) using CPAP
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1 week
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Proportion of Participants Who Complete Protocol After Allocation
Tidsramme: Duration of protocol period
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Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT
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Duration of protocol period
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Proportion of Participants Who Withdrawal
Tidsramme: Duration of protocol period
|
Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT
|
Duration of protocol period
|
|
Acceptability of Study Intervention and Comparative Group
Tidsramme: 3 months
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Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to "interview" at study termination and debriefing (3 months)
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3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Amy M Sawyer, PhD, The Pennsylvania State University
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
- Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011 Dec;15(6):343-56. doi: 10.1016/j.smrv.2011.01.003. Epub 2011 Jun 8.
- Sawyer AM, Deatrick JA, Kuna ST, Weaver TE. Differences in perceptions of the diagnosis and treatment of obstructive sleep apnea and continuous positive airway pressure therapy among adherers and nonadherers. Qual Health Res. 2010 Jul;20(7):873-92. doi: 10.1177/1049732310365502. Epub 2010 Mar 30.
- Sawyer AM, Canamucio A, Moriarty H, Weaver TE, Richards KC, Kuna ST. Do cognitive perceptions influence CPAP use? Patient Educ Couns. 2011 Oct;85(1):85-91. doi: 10.1016/j.pec.2010.10.014. Epub 2010 Nov 10.
- Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, Pack AI. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep. 2003 Sep;26(6):727-32. doi: 10.1093/sleep/26.6.727.
- Yang H, Watach A, Varrasse M, King TS, Sawyer AM. Clinical Trial Enrollment Enrichment in Resource-Constrained Research Environments: Multivariable Apnea Prediction (MAP) Index in SCIP-PA Trial. J Clin Sleep Med. 2018 Feb 15;14(2):173-181. doi: 10.5664/jcsm.6926.
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
1. november 2011
Primær fullføring (Faktiske)
1. mars 2014
Studiet fullført (Faktiske)
1. mars 2014
Datoer for studieregistrering
Først innsendt
12. oktober 2011
Først innsendt som oppfylte QC-kriteriene
17. oktober 2011
Først lagt ut (Anslag)
19. oktober 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. september 2016
Sist bekreftet
1. september 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 37007
- 4R00NR011173 (U.S. NIH-stipend/kontrakt)
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. .