- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02475577
Determine Return on Investment in Heart Failure Remote Monitoring Program
29. marts 2016 opdateret af: 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).
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret 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).
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
163
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Florida
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Naples, Florida, Forenede Stater, 34102
- Rekruttering
- NCH Healthcare System
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Kontakt:
- Laurie Zone-Smith, PhD
- Telefonnummer: 239-624-4986
- E-mail: laurie.zonesmith@nchmd.org
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Kontakt:
- Theresa L Morrison, PhD
- Telefonnummer: 239-624-4384
- E-mail: theresa.morrison@nchmd.org
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-
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
18 år til 89 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 navne:
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Eksperimentel: 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 navne:
|
|
Eksperimentel: 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 navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
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31 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Communication with healthcare provider or emergency department
Tidsramme: 31 days
|
Communication that resulted in unplanned healthcare provider office visits or visit to emergency department
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31 days
|
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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
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31 days
|
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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
|
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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.
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31 days
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number and type of incidents
Tidsramme: 31 days
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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
|
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Subject attrition
Tidsramme: 31 days
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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.
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31 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Theresa Morrison, PhD, NCH Healthcare System Inc
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. juni 2015
Primær færdiggørelse (Forventet)
1. juni 2017
Studieafslutning (Forventet)
1. august 2017
Datoer for studieregistrering
Først indsendt
12. juni 2015
Først indsendt, der opfyldte QC-kriterier
17. juni 2015
Først opslået (Skøn)
18. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15-001
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 .
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