- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00217867
Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization
A RCT to Reduce Cardiopulmonary Rehospitalization
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
BACKGROUND:
Limited health literacy is prevalent in America and has been identified as a cross-cutting priority area for transforming health care quality. This study will explore the effect of innovative patient-education and self-management systems on early rehospitalization for patients admitted to a general medical service.
DESIGN NARRATIVE:
This is a two-armed randomized study of patients with chronic cardiopulmonary diseases in three levels of health literacy. Patients will be tested with the 66 word version of the Rapid Estimate of Adult Literacy in Medicine (REALM) test to allow us to analyze the data according to literacy categories ( 6th grade, 7th-8th grade, and 9th grade). Patients will be randomized to one of the following groups: 1) standard discharge (control group); 2) a experimental group receiving both the case management intervention plus educational and self-management support by Embodied Conversational Agents (ECAs) and post-discharge reinforcement of the discharge plan using a computerized telephone system
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Admitted to the general medical service at Boston Medical Center (BMC)
- Desires to be hospitalized in the future if there is a clinical need
- Able to communicate in English with health providers
Exclusion Criteria:
- Transferred from an outside hospital or a specialty services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry)
- Requires hospice, nursing home, or other institutional settings
- Vision that is inadequate to discern the computer-based education and self-management support system
- Hearing that is inadequate to use a telephone
- Unable to independently consent
- Scheduled admission (e.g. for surgery)
- Has sickle cell disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: 1
Usual Care, defined as the usual hospital discharge process as delivered by nurses and doctors.
|
|
Eksperimentel: 2
Use of animated computerized character to prepare subjects for discharge by reviewing information provided to subjects in a printed After Hospital Care Plan packet, followed by telephone system to reinforce the discharge.
|
Animated character will teach the discharge plan before discharge, then this teaching will be reinforced by computerized telephone system.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rehospitalization
Tidsramme: Measured at 30 days
|
Measured at 30 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Subject satisfaction with intervention and hospital experience
Tidsramme: Measured at discharge and 30 days
|
Measured at discharge and 30 days
|
Subject readiness for discharge
Tidsramme: Measured at 30 days
|
Measured at 30 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Brian Jack, MD, Boston Medical Center
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-25057
- R01HL081307 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 Hjertesygdomme
-
Region SkaneTilmelding efter invitationHjertesvigt New York Heart Association (NYHA) klasse II | Hjertesvigt New York Heart Association (NYHA) klasse IIISverige
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... og andre samarbejdspartnereIkke rekrutterer endnuHjertesvigt, systolisk | Hjertesvigt med reduceret udstødningsfraktion | Hjertesvigt New York Heart Association Klasse IV | Hjertesvigt New York Heart Association Klasse IIIPolen
-
University of WashingtonAmerican Heart AssociationAfsluttetHjertesvigt, Kongestiv | Mitokondriel ændring | Hjertesvigt New York Heart Association Klasse IVForenede Stater
-
Novartis PharmaceuticalsAfsluttetPatienter, der med succes afslutter den 12-måneders behandlingsperiode i kernestudiet (de Novo Heart-modtagere), som var interesserede i at blive behandlet med EC-MPS
-
University Hospital, GasthuisbergUkendtTransient Left Ventricular Ballooning SyndromeBelgien
-
NYU Langone HealthRekrutteringTako-tsubo kardiomyopati | Takotsubo kardiomyopati | Broken Heart SyndromeForenede Stater
-
French Cardiology SocietyAfsluttet
Kliniske forsøg med Animated character intervention with telephone follow-up
-
Johns Hopkins UniversityChildren's Hospital of Philadelphia; Columbia University; Research Foundation... og andre samarbejdspartnereIkke rekrutterer endnuSelvmord, Forsøg | Selvmord | Selvmordstanker | Selvmordsforebyggelse