Virtual PREHAB Study for Patients Undergoing TAVI

Nova Scotia Health Authority (NSHA)

Status: Enrolling

Conditions: Cardiovascular Diseases in Old Age; Frailty; TAVI

Treatments: Behavioral: Standard care; Behavioral: Virtual PREHAB

Study type: Interventional

Funder types: Other

Identifiers

NCT05617196

NS-NHIG-2021-1905

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Standard Care

Active Comparator group

Treatment:

Behavioral: Standard care

Virtual PREHAB

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual PREHAB