- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02078622
Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients With COPD (RTQOL)
A Prospective Randomized Controlled Trial to Evaluate the Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients Diagnosed With COPD
Evaluate subjects in an prospective randomized controlled trial in which subjects will be administered scientifically validated questionnaires to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and quality of life as primary endpoints
Utilize: Chronic Respiratory Disease Questionnaire (CRQ)
The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency room encounters, hospital admissions)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
California
-
Carlsbad, California, Forenede Stater, 92008
- Isabel Pereira, Md
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Diagnosis of COPD
- Cognitive ability to retain education and training
- Resides in a stable residence or home, apartment
- Managed by primary care physician (family practice)
Exclusion Criteria:
- Lacks cognitive ability to retain education and training
- Not managed by primary care physician (family practice)
- No stable residence or is homeless
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
COPD, Education and Case Management
Respiratory Therapist Education and Case Management
|
Respiratory Therapists will conduct home care visits over a period of one-year at two-week intervals
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of Life Using Chronic Respiratory Disease Questionnaire
Tidsramme: Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life
|
Using the CRQ Evaluate Health Outcomes and QOL
|
Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Healthcare Utilization
Tidsramme: 1 year
|
Hospital Admission, Emergency Room Encounters
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: ISABEL PEREIRA, MD, StratiHealth
- Studieleder: VERNON R PERTELLE, RRT, StratiHealth
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20140101S
- SH20140101S (Andet bevillings-/finansieringsnummer: STRATIHEALTH)
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 Respiratory Therapist Education and Case Management
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Afsluttet
-
Omada Health, Inc.Palo Alto Medical Foundation; Sutter HealthAfsluttetType 2 diabetesForenede Stater
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Rekruttering
-
University of MichiganNational Institute on Aging (NIA)RekrutteringKronisk smerte | Kognitiv svækkelseForenede Stater
-
University of ArizonaRekruttering
-
NYU Langone HealthAgency for Healthcare Research and Quality (AHRQ)Ikke rekrutterer endnuType 2 diabetesForenede Stater
-
Chinese University of Hong KongIntegrated Community Care and Family Support CentresAfsluttetFamilieplejere | Skizofreni spektrum lidelserHong Kong
-
Omada Health, Inc.Abbott Diabetes Care; Evidation HealthAfsluttetType 2 diabetesForenede Stater
-
Sinai Health SystemRekrutteringDiabetes mellitus, type 2 | Diabetes mellitus | Diabetes | Diabetes mellitus, type 1Forenede Stater
-
University of ArkansasTrukket tilbageDiabetes mellitus, type 2 | SøvnhygiejneForenede Stater