- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02475577
Determine Return on Investment in Heart Failure Remote Monitoring Program
29. mars 2016 oppdatert av: NCH Heatlhcare System Inc
A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program
The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).
Studietype
Intervensjonell
Registrering (Forventet)
163
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Florida
-
Naples, Florida, Forente stater, 34102
- Rekruttering
- NCH Healthcare System
-
Ta kontakt med:
- Laurie Zone-Smith, PhD
- Telefonnummer: 239-624-4986
- E-post: laurie.zonesmith@nchmd.org
-
Ta kontakt med:
- Theresa L Morrison, PhD
- Telefonnummer: 239-624-4384
- E-post: theresa.morrison@nchmd.org
-
-
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 til 89 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Absence of significant vision, hearing, or other communication deficits
- English speaking;
- Capable and willing to give informed consent;
- Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
- Living in a private home;
- Hospital admission for Heart Failure or decompensation in the previous 12 months
- New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist
- Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular
- Left ventricular ejection fraction <40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
or
- NYHA class II-III who had an ejection fraction >40% and evidence of diastolic left ventricular dysfunction.
- Optional subject with a diagnosis of diabetes (indicated by HbA1c >7).
Exclusion Criteria:
- Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
- Females who are pregnant, planning to become pregnant within 3 months, or lactating;
- Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
- Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
- End-stage heart failure requiring regular inotropic drug infusions;
- Chronic renal failure requiring dialysis treatment and
- Unstable angina.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Control
Control: Peripherals with HealthInterlink technology will record and transmit data, without intervention.
Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver.
|
home remote monitoring
Andre navn:
|
|
Eksperimentell: Intervention 1
Intervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver.
|
home remote monitoring
Andre navn:
|
|
Eksperimentell: Intervention 2
Intervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts).
The physicians will have access to the subject's data on a web-based program.
|
home remote monitoring
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
Tidsramme: 31 days
|
31 days post discharge with a heart failure-related hospital re-hospitalization.
|
31 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Communication with healthcare provider or emergency department
Tidsramme: 31 days
|
Communication that resulted in unplanned healthcare provider office visits or visit to emergency department
|
31 days
|
|
Number of non-conformity issues
Tidsramme: 31 days
|
Number of non-conformity telephone reminder texts, emails, and/or calls.
|
31 days
|
|
Health-related quality of life Questionnaire
Tidsramme: 31 days
|
Health-related quality of life
|
31 days
|
|
Subject satisfaction Questionnaire
Tidsramme: 31 days
|
Subject satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use, time to complete testing and questionnaire, benefit that promoted better health
|
31 days
|
|
Physician satisfaction Questionnaire
Tidsramme: 31 days
|
Physician satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use of software, benefit that promoted better communication with subject.
|
31 days
|
|
Cost of system and intervention per subjects
Tidsramme: 31 days
|
Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups.
|
31 days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number and type of incidents
Tidsramme: 31 days
|
Number and type of incident based on predefined criteria from the remote monitoring data (clinical signs and symptoms related to worsening of cardiac insufficiency or to its complications).
|
31 days
|
|
Subject attrition
Tidsramme: 31 days
|
Rate of subjects discontinuing the study due to Patient Request, Patient Complaint, Patient Transferred to higher level of care (ACLF, SNF), Patient Hospitalized, Physician Request Monitoring No Longer Needed (Resolution of Disease Process, Change in Treatment), Physician Complaint, Patient Expired, Patient all-cause mortality or Without other identifiable cause.
|
31 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Theresa Morrison, PhD, NCH Healthcare System Inc
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.
Hjelpsomme linker
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. juni 2015
Primær fullføring (Forventet)
1. juni 2017
Studiet fullført (Forventet)
1. august 2017
Datoer for studieregistrering
Først innsendt
12. juni 2015
Først innsendt som oppfylte QC-kriteriene
17. juni 2015
Først lagt ut (Anslag)
18. juni 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
31. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15-001
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. .
Kliniske studier på Hjertefeil
-
Istanbul UniversityHar ikke rekruttert ennåTidlig mobilisering, Open-Heart Surgery, Virtual RealityTyrkia
-
Region SkanePåmelding etter invitasjonHjertesvikt New York Heart Association (NYHA) klasse II | Hjertesvikt New York Heart Association (NYHA) klasse IIISverige
-
Medical University of BialystokMedical University of Lodz; Poznan University of Medical Sciences; Nicolaus... og andre samarbeidspartnereAvsluttetHjertesvikt, systolisk | Hjertesvikt med redusert utkastningsfraksjon | Hjertesvikt New York Heart Association Klasse IV | Hjertesvikt New York Heart Association klasse IIIPolen
-
Luigi Sacco University HospitalIRCCS Azienda Ospedaliero-Universitaria di Bologna; University of Padova; Università degli Studi di Ferrara og andre samarbeidspartnereRekrutteringAtrieflimmer | Block Complete HeartItalia, Belgia, Sveits
-
University of WashingtonAmerican Heart AssociationFullførtHjertesvikt, Kongestiv | Mitokondriell endring | Hjertesvikt New York Heart Association Klasse IVForente stater
-
Portuguese Association of Interventional CardiologyMedtronicRekrutteringAlvorlig symptomatisk aortastenose (definert som New York Heart Association (NYHA) klasse ≥ II)Portugal
-
Novartis PharmaceuticalsFullførtPasienter som har fullført den 12-måneders behandlingsperioden i kjernestudien (de Novo Heart-mottakere) som var interessert i å bli behandlet med EC-MPS
-
University Hospital, GasthuisbergUkjentTransient Left Ventricular Ballooning SyndromeBelgia
-
NYU Langone HealthRekrutteringTako-tsubo kardiomyopati | Takotsubo kardiomyopati | Broken Heart SyndromeForente stater
-
French Cardiology SocietyFullført
Kliniske studier på Peripherals with HealthInterlink technology
-
Universidad Nacional Autonoma de MexicoRekruttering