Virtual PREHAB Study for Patients Undergoing TAVI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual PREHAB, Standard care.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases in Old Age, Frailty, TAVI. Basic parameters: 50 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility of a Virtually Delivered Preoperative Rehabilitation Program for Patients Awaiting TAVI to Reduce Frailty: The Virtual PREHAB Study
Overview
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.
Interventions
- Behavioral Virtual PREHAB
The Virtual PREHAB program begins with a virtual health care team assessment. The physiotherapist will support patients in identifying ways to safely engage in home-based physical activities and in their neighborhoods. Additional weekly 30-minute telephone consultations with the physiotherapist, nurse, and dietitian are provided as well as three 30-minute online consultations are provided; telephone calls will replace these online consults if the patient does not have internet access. Telephone - Behavioral Standard care
In Nova Scotia, patients are referred to the TAVI program. The TAVI health care team, consisting of a cardiac surgeon, cardiologist, nurse, and geriatric team conduct patient assessments and provide guidance and resources on self management.Once patient assessments are completed, patients are discussed at a multidisciplinary team meeting. When a patient is accepted for TAVI, they are placed on a waiting list which lasts for 3-6 months depending on urgency.
Primary outcome measures
- CLSA-FI [Time frame: Baseline]
- CLSA-FI [Time frame: 8-weeks preoperatively]
- CLSA-FI [Time frame: 1-week preoperatively]
- CLSA-FI [Time frame: 3-months postoperatively]
- PFFS-FI [Time frame: Baseline]
- PFFS-FI [Time frame: 1-week preoperatively]
- PFFS-FI [Time frame: 8-weeks preoperatively]
- PFFS-FI [Time frame: 3-months postoperatively]
Secondary outcome measures (7)
- EQ-5D-5L health-related quality of life [Time frame: Baseline]
- EQ-5D-5L health-related quality of life [Time frame: 8-weeks preoperatively]
- EQ-5D-5L health-related quality of life [Time frame: 1-week preoperatively]
- EQ-5D-5L health-related quality of life [Time frame: 3-months postoperatively]
- VARC-3 Composite clinical end-points [Time frame: Hospital discharge (assessed up to day 14)]
- VARC-3 Composite clinical end-points [Time frame: 30-days postoperatively]
- Cardiac rehabilitation attendance [Time frame: 3-months postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Nova Scotia Health — Halifax
Identifiers
NCT: NCT05617196 · NS-NHIG-2021-1905