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Advanced eHealth for Chronic Obstructive Pulmonary Disease (COPD) in Colorado

3. oktober 2012 opdateret af: University of Colorado, Denver

Phase 3 Clinical Trial Studying the Efficacy of a Proactive Integrated Approach to Care in Patients With Advanced COPD

Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death in the United States, affects 24 million people and is responsible for up to $32 billion annually in direct and indirect health care costs. Based upon these national COPD prevalence data, we estimate that 483,000 Coloradans have COPD (193,000 diagnosed and 290,000 undiagnosed), and that the care of these patients costs up to $490 million annually. Therefore, to alter the impact of COPD on the State and People of Colorado, we propose to introduce a telephone-dependent, internet-supported, self-monitoring "eHealth" management system in both urban and rural Colorado settings in order to decrease healthcare utilization, improve the management of COPD based upon current national guidelines, improve quality of life, reduce health care costs decrease COPD exacerbations. We base this program on a successful clinical pilot study, performed at the University of Colorado Hospital (UCH) during 2004-2005, which demonstrated dramatic improvements in quality of life and decreased health care costs. We propose to enroll patients with advanced COPD, or a history of COPD exacerbations, because these are the patients with the highest healthcare costs, the greatest disability, and the highest mortality. The ultimate goal of this project is to demonstrate the feasibility and efficacy of this proactive management strategy as it is disseminated throughout urban and rural Colorado. In this first phase we will target two Denver Metro sites, UCH and Kaiser-Permanente (KP), and rural sites (to be determined). We chose these urban sites because of their strong interest in enacting the eHealth Program, because of their organized systems of healthcare delivery and because of the numbers of COPD patients that they serve. We are particularly enthusiastic about the application of this technology to rural, underserved areas, because this approach has the potential to dramatically improve delivery of healthcare to a large portion of Colorado that is chronically plagued by inadequate health care networks and lack of specialty care. More broadly, we are enthusiastic about the prospect that eHealth programs may hold the potential to improve healthcare delivery for many chronic illnesses, in addition to COPD.

Studieoversigt

Status

Afsluttet

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

511

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Hospital
      • Denver, Colorado, Forenede Stater, 80218
        • Kaiser Permanente

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • COPD Diagnosis per GOLD Guidelines
  • Airflow obstruction on spirometry defined as an FEV1/FVC less than or equal to 70% and an FEV1 less than or equal to 50% predicted, or an FEV1 greater than 50% predicted with a history of a COPD exacerbation within the previous year.
  • Standard telephone access
  • US Citizen and Colorado resident

Exclusion Criteria:

  • Asthma
  • Co-existing conditions that are likely to cause death within two years, CXR evidence of interstitial lung disease or other pulmonary diagnoses at the time of enrollment, end-stage liver disease, end-stage renal disease, end-stage muscle disease, HIV disease or dementia.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Proactive Integrated Care
COPD-specific education, self-management instruction, remote monitoring and enhanced communication with a coordinator
Comparison of the effect of COPD education, self-management instruction, home monitoring with a Health Buddy Telemonitor, pulse oximeter, pedometer and spirometer, and enhanced communication with a study coordinator (cell phone access)
Aktiv komparator: Standard Care Control
No intervention other that measurements taken at 0, 3, 6 and 9 months of the study.
No intervention was made. Data measurements were taken at 0, 3, 6 and 9 months, as in the active intervention group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Udnyttelse af sundhedsvæsenet
Tidsramme: 9 måneder
9 måneder

Sekundære resultatmål

Resultatmål
Tidsramme
Quality of Life by St. Georges Respiratory Questionnaire
Tidsramme: 3, 6 and 9 months
3, 6 and 9 months
Guideline-based medical therapy
Tidsramme: 9 months
9 months
Exercise capacity
Tidsramme: 9 months
9 months
Oxygen utilization and pre-and post-exercise oxygen saturations
Tidsramme: 9 months
9 months
Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) index
Tidsramme: 9 months
9 months
Symptoms including cough, sputum production and dyspnea (modified Medical Research Council (MMRC) MMRC Dyspnea Scale)
Tidsramme: 9 months
9 months
Smoking status
Tidsramme: 9 months
9 months
Pulmonary rehabilitation
Tidsramme: 9 months
9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: William Vandivier, MD, University of Colorado, Denver

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2006

Primær færdiggørelse (Faktiske)

1. august 2007

Studieafslutning (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først indsendt

6. januar 2010

Først indsendt, der opfyldte QC-kriterier

7. januar 2010

Først opslået (Skøn)

8. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 06-0587
  • 07 FLA 00834 (Anden identifikator: CDPHE)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Integrated Care

3
Abonner