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ThErapy Adherence Management in Veterans

10. mai 2019 oppdatert av: University of Florida

ThErapy Adherence Management in Veterans: A Randomized Trial

The study is a prospective, randomized, controlled trial studying adherence to positive airway pressure therapy in a population referred to the VA system for the treatment of sleep disordered breathing. The primary aim of the study is to determine if, compared to standard care provided at a VA Sleep Center, the deployment of a structured adherence management program and a web-based information program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting Centers for Medicare & Medicaid Services (CMS) adherence requirements (use > 4 hours for >= 70% of days) at 90 days.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The primary aim of the study is to determine if, compared to standard care provided at a VA Sleep Center, the deployment of a structured adherence management program and a web-based information program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting CMS adherence requirements (use > 4hrs on >=70% of nights) at 90 days.

Secondary aims:

  1. Results in higher nightly use of therapy (hours per night and % of nights with at least 4 hours of use) at 90 days
  2. Results in participant satisfaction that is superior to current standard care
  3. Offers operational efficiencies or economic benefits to the health care facility (reduced staff time (sleep clinic and physician), equipment consumption, unplanned participant contacts or visits, and reduced overtime)
  4. Results in indirect benefits to participants (fewer clinic visits, less travel or in-clinic/ office visit waiting time)

Studietype

Intervensjonell

Registrering (Faktiske)

250

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Florida
      • Gainesville, Florida, Forente stater, 32611
        • University of Florida
      • Gainesville, Florida, Forente stater, 32608
        • Malcom Randall VA Medical Center

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

21 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Ages 21 to 85
  • Diagnostic Apnoea-Hypopnoea Index (AHI) ≥ 15 determined by in lab polysomnography (PSG) or home sleep testing (HST) or by a sleep therapy device
  • Eligible for treatment with Automatically adjusted CPAP or Automatically adjusted BiPAP
  • Currently has a Smart Phone or home access (computer with internet access) to the internet based version of the software application

Exclusion Criteria:

  • Participation in another interventional research concerned with sleep disorders within the last 30 days
  • Major uncontrolled medical condition that would interfere with the demands of the study, adherence to PAP, or the ability to commit to follow-up assessment including conditions such as poorly managed or controlled or advanced stages of pulmonary disease, cardiac disease, neurological disease, neuromuscular disease, cancer, and renal disease.
  • Prior PAP use within the previous 12 months.
  • Predominantly Central Apneas (≥ 50% central apneas) or Cheyne Stokes Respiration (CSR) (≥ 20% of Total Sleep Time (TST) with CSR)
  • Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake or the requirement for supplemental oxygen (at night or continuous) or mechanical ventilation.
  • Surgery involving the upper airway, nose, sinus, eye, teeth, or middle ear within the previous 90 days
  • PAP therapy is otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PAMS service

Study participants will be randomly assigned to have their Continuous positive airway pressure therapy (CPAP) or Bilevel Positive Airway Pressure (BiPAP) therapy followed by a structured patient adherence management service (PAMS).

Interventions: Call to patient by sleep coach on days 3,7,14,32,45, 60, and 75 after participants begin PAP treatment. At each time frame sleep coach reviews CPAP adherence data on EncoreAnywhere (EA) a cloud based program collecting adherence data via wireless modem on CPAP units. Calls will not be made at days 7 and 14 if adherence is good. If problems are identified and cannot be handled over the telephone the problems will be escalated to VA MD or CPAP respiratory therapy (RT) providers for direct intervention. All patients are seen in sleep clinic by a VA MD sleep provider 3 months after starting treatment.
Atferdsmessig: structured adherence management program
Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy
Aktiv komparator: Standard Care (SCP)
Study participants will be randomly assigned to have their CPAP or BiPAP therapy followed by the current Sleep Center standard care process. This includes a telephone number that patients can call or problems and review of adherence data on EncoreAnywhere (EA) at 4 to 6 weeks after starting treatment. Patients are seen in sleep clinic by a VA MD sleep provider 3 months after starting treatment.
Atferdsmessig: Standard of care
Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Increase on CMS adherence requirements
Tidsramme: at 90 days
The requirements are greater than 4 hours use for 70% of nights
at 90 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Nightly use of therapy
Tidsramme: at 90 days
Hours per night and % of nights with at least 4 hours of use
at 90 days
Participant satisfaction
Tidsramme: at 90 days
Participants will complete at "Patients Satisfaction Survey" containing 5 questions about their satisfaction with CPAP treatment and the process of starting CPAP. There is a 5 point scale from very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4), very unsatisfied (5). Score can vary from 5 to 25. 30,
at 90 days
Operational efficiencies and economic benefits to the health care facility
Tidsramme: at 90 days
Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time
at 90 days

Samarbeidspartnere og etterforskere

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

Sponsor

University of Florida

Samarbeidspartnere

US Department of Veterans Affairs
Philips Respironics

Etterforskere

  • Hovedetterforsker: Richard B Berry, MD, Malcom Randall VAMC

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)

8. august 2017

Primær fullføring (Faktiske)

9. mai 2019

Studiet fullført (Faktiske)

9. mai 2019

Datoer for studieregistrering

Først innsendt

4. august 2017

Først innsendt som oppfylte QC-kriteriene

4. august 2017

Først lagt ut (Faktiske)

9. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB201701153
  • ST-17043-VAPAM-JP (Annen identifikator: University of Florida Internal ID)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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