Virtual PREHAB Study for Patients Undergoing TAVI

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases in Old Age; Frailty; TAVI
• Interventions: Behavioral: Standard care; Behavioral: Virtual PREHAB

• Registration Number: NCT05617196
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

Nova Scotians are aging and many are becoming frailer. People with frailty are more likely to live in worse health and do not recover well from major events, such as open heart surgery. Many people are also too frail to receive open heart surgery. Less invasive procedures called transcatheter aortic valve implantation, or TAVI, are provided for the frailest patients. While TAVI is life-saving, frailer patients are less likely to survive in better health after their operation. Patients in Nova Scotia can also wait up to 3-6 months for their operation where they become frailer or can die before receiving TAVI. The investigators believe that it is important to support these individuals to improve their frailty and overall health before their operation.

Center-based cardiac rehabilitation is offered to patients after, but not before TAVI to improve their health. Center-based preoperative cardiac rehabilitation (i.e., PREHAB) can safely improve the function of frail patients who received open heart surgery. However, many patients cannot come to a center-based PREHAB because of transportation requirements to access the program. Another option is to support these patients with virtually delivered PREHAB, where they can stay in their homes. However, this possibility has not been studied.

For this study, virtual PREHAB will be delivered using the virtual cardiac rehabilitation program in Nova Scotia to patients before TAVI. This intervention will be delivered by healthcare providers who routinely care for TAVI patients, including a medical director, program lead, nurse, physiotherapist, and dietician. Ther goal of this study is to determine if it is feasible and safe to use virtual PREHAB to reduce frailty before TAVI. This research fits with Research Nova Scotia's priorities to improve patient outcomes in those with significant long-term health conditions, and to provide accessible, safe, and quality virtual healthcare to patients so they can thrive after their operation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-15
• Study Start: 2023-01-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre
• Informed written or verbal consent

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Exclusion Criteria

• New York Heart Association or Canadian Cardiovascular Score of 4
• Severe functional limitations
• Cognitive impairment that impacts consenting ability
• Significant language barrier
• No internet or telephone access that precludes virtual PREHAB participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard care	-
Virtual PREHAB	Virtual PREHAB	In addition to standard care, participants randomized to the The virtual PREHAB program will be delivered by the Hearts and Health in Motion cardiac rehabilitation CR health care team including a medical director nurse, dietician, and physiotherapist who routinely deliver CR postoperatively. The virtual PREHAB program will be up to 8-weeks in duration and deliver the core components of CR online or by telephone.

Primary Outcome Measures

Name	Time	Method
CLSA-FI	3-months postoperatively	Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
PFFS-FI	3-months postoperatively	Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)

Secondary Outcome Measures

Name	Time	Method
Cardiac rehabilitation attendance	3-months postoperatively	Percent of people attending cardiac rehabilitation
EQ-5D-5L health-related quality of life	3-months postoperatively	Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
VARC-3 Composite clinical end-points	30-days postoperatively	Valvular Academic Research Consortium V.3.0 clinical endpoints (Mortality, Neurologic events, Hospitalization, Rehospitalization, Bleeding and transfusions, Vascular and access-related complications, Cardiac structural complications, Other procedural or valve-related complications, New conduction disturbances and arrhythmias, New conduction disturbances and arrhythmias, Myocardial infarction, Bioprosthetic valve dysfunction, Leaflet thickening and reduced motion, Clinically significant valve thrombosis, Patient-reported outcomes and health status. Fewer complications indicate a better surgical outcome

Trial Locations

Locations (1)

Nova Scotia Health; 🇨🇦 Halifax, Nova Scotia, Canada