- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00778986
Effects of Remote Patient Monitoring on Heart Failure Management
Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Poor management of heart failure (HF) has added to the high costs and negative health outcomes from this chronic illness, including frequent hospitalization. HF patients require close monitoring to detect worsening health and to optimize their treatment. However, many patients visit their HF clinicians only once every few months, and perform minimal or no self-monitoring.
Remote patient monitoring is a potential tool to help clinicians and the patients better manage HF. A remote patient monitoring system (home monitoring of vital signs and symptoms) that has been developed with extensive clinician and patient input and testing, will be studied to determine its effects on HF management. Half of one hundred patients from the University Health Network Heart Failure Clinic will be randomly placed into the remote monitoring (RM) group and the other half will be in the control group. Patients in the RM group will monitor their weight, blood pressure, ECG, and symptoms at home for 6 months. This information will be automatically sent from the medical devices wirelessly through Bluetooth to a mobile phone, which will send the information to the data servers. Both clinicians and patients will have access to the data. Patients will get automated reminder telephone calls if they do not take the number of measurements prescribed by their doctors.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of Heart Failure (NYHA Class II-IV)
- Out-patients attending the University Health Network Heart Failure Clinic
- English-speaking and able to read English
- 18 years old or over
Exclusion Criteria:
- Awaiting heart transplantation
- Not expected to survive over a year (as determined by their cardiologist)
- Unable to read text on a mobile phone due to vision disability
- Unable to self-care due to anxiety, depression, or decreased cognitive function
- Lack of manual dexterity to accurately press buttons on the mobile phone
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: remote monitoring
group of patients that will be using the heart failure remote patient monitoring system in addition to the usual care they receive at the University Health Network Heart Failure Clinic
|
remote monitoring of weight, blood pressure, ECG, and symptoms
|
|
Ingen indgriben: control
group of patients provided with usual care at the University Health Network Heart Failure Clinic
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Brain Natriuretic Peptide values
Tidsramme: Baseline, 6 months
|
Baseline, 6 months
|
|
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Tidsramme: baseline, 6 months
|
baseline, 6 months
|
|
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
Tidsramme: baseline, 6 months
|
baseline, 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of hospitalizations and days in hospital
Tidsramme: 6 months comparison between intervention and control groups
|
6 months comparison between intervention and control groups
|
|
Number of Emergency Department visits
Tidsramme: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
|
All cause mortality
Tidsramme: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
|
Number of Heart Failure Clinic visits
Tidsramme: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Heather J Ross, MD, MHSc, University Health Network, Toronto
Publikationer og nyttige links
Generelle publikationer
- Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system. Int J Med Inform. 2012 Aug;81(8):556-65. doi: 10.1016/j.ijmedinf.2012.03.001. Epub 2012 Mar 31.
- Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HF-RPM-UHN
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 .