- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05349708
Telehealth Home-monitoring for Frailty in Cardiac Surgery (THE-FACS)
Benefit of a Telehealth Home-monitoring Program for Vulnerable Patients and Patients Living With Frailty Undergoing Heart Surgery
Cardiac surgical interventions are increasingly offered to vulnerable patients or patients living with frailty. Unfortunately, frailty has been shown to be an independent predictor of poorer outcome and increased health care resources in terms of readmission to hospital or visit to the ER after discharge. We hypothesize that the use of a comprehensive Telehealth home-monitoring program could reduce emergency room visits and re-hospitalization after heart surgery.
Frailty in all patients will be determined using the Edmonton frailty scale (EFS) as is part of the current standard of care for all patients at the NBHC since 2018. We plan to implement the Telehealth intervention on all 120 consecutively enrolled patients identified as vulnerable and/or frail and discharged from hospital within 10 days of their surgery. The primary outcome of interest will be rates of ER visit and readmission to hospital within 30 days of discharge compared to propensity score matched historical control patients. A power calculation suggests that 120 patients per group are necessary explaining why the intervention group will be 120 patients. We chose to compare our intervention to a matched group of 240 individuals from historical data which already captures follows patients 30 days after surgery but is limited in its Telehealth intervention. Duration of the study is 12 months.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
New Brunswick
-
Saint John, New Brunswick, Canada, E2L4L4
- New Brunswick Heart Centre, Saint John Regional Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients, aged 55 years or older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement, mitral valve repair/replacement or combined CABG/valve procedures.
- Patients defined as pre- vulnerable, vulnerable or frail based on the Edmonton frailty scale (> 4 considered pre- vulnerable) as defined prior to surgery
Exclusion Criteria:
Medical reasons for exclusion
- Patients who have unstable or recent unstable cardiac syndrome requiring urgent (within 24hr) or emergent surgery
- Acute endocarditis who are at higher risk for adverse events
- Dialysis dependent who are at higher risk for adverse events
- Patients who have cognitive deficits, visual impairments, inability to read or major difficulties with electronic devices that would preclude use of the intervention
- Patients who do not have any support or potential caregivers to help facilitate their transition home
- Patients undergoing minimally invasive surgery which has been shown to enhance recovery
- Patients unable to be discharged home within 10 days of their surgery. The average length of hospitalization is 5 days with frail patients often requiring additional time but usually within 10 days unless some major barrier exists in allowing discharge home.
- Patients who are transferred to another hospital for recovery or care.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Participant
Patients who were sent home with the intervention post-surgery
|
Telehealth home-monitoring tablet and blood pressure cuff
|
Geen tussenkomst: Historical controls
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Rates of emergency room visit and readmission to hospital
Tijdsspanne: 30 days of discharge post-cardiac surgery
|
The aim was to compare the rate of emergency room visits and readmission to hospital within 30 days of discharge between two groups of patients: frail, post-surgery cardiac surgery patients who went home with the intervention for self-monitoring of health versus historical controls
|
30 days of discharge post-cardiac surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Length of hospital stay (LOS, days) and discharge disposition
Tijdsspanne: Duration of stay at the hospital post-cardiac surgery
|
The post-surgery inclusion criterion was the LOS of 10 days or less and home-discharge.
The investigators, therefore, assessed the LOS and discharge disposition of the frail participants who consented to participate in the study to understand the challenges in recovery and ability to participate in the study.
|
Duration of stay at the hospital post-cardiac surgery
|
Rate of readmission to hospital and/or ER visit and reasons
Tijdsspanne: 30 days of discharge post-cardiac surgery
|
The aim of the telehealth home monitoring platform was to reduce hospital readmission and/ or ER visits within 30 days of discharge post-cardiac surgery.
The investigators, therefore, wanted to explore the rates and causes for the above-mentioned outcomes.
|
30 days of discharge post-cardiac surgery
|
Percentage of patients who faced difficulties with the Telehealth intervention and causes of the same
Tijdsspanne: 30 days of discharge post-cardiac surgery
|
Identification of the major challenges frail participants faced in using a technology-based home monitoring program to self-monitor their health and recovery post-cardiac surgery.
A participation-satisfaction questionnaire was used to assess the percentage of patients who could/ count not use the intervention and the reasons for such (technological challenges, connectivity ussies, etc.).
|
30 days of discharge post-cardiac surgery
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 100097
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op THE-FACS
-
Memorial Sloan Kettering Cancer CenterBeëindigdDe familie of verwanten van patiënten die bij MSKCC zijn behandeld voor niet-cutane plaveiselcelcarcinomen van de | Bovenste spijsverteringskanaalVerenigde Staten
-
Istanbul Physical Medicine Rehabilitation Training...VoltooidHerstel van een beroerteKalkoen
-
University of VictoriaVoltooid
-
Memorial Sloan Kettering Cancer CenterWervingAlvleesklierkanker | Ductaal adenocarcinoom van de alvleesklierVerenigde Staten
-
Yu-Hsiang WuNational Institute on Deafness and Other Communication Disorders (NIDCD)Werving
-
Duke UniversityVoltooidSeksuele voorlichtingVerenigde Staten
-
University of New BrunswickHorizon Health Network; Universite de Moncton; New Brunswick Health Research Foundation en andere medewerkersVoltooid
-
LeMaitre VascularAvaniaWervingTrombus | Embolus | Occlusie; SchipDuitsland, Zwitserland
-
Asian Institute of Gastroenterology, IndiaOvesco Endoscopy AGNog niet aan het werven