Health TrialsbyHealthPanel

Virtual PREHAB Study for Patients Undergoing TAVI

ConditionsCardiovascular Diseases in Old AgeFrailtyTAVI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorNova Scotia Health Authority

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre

Informed written or verbal consent

Disqualifiers

New York Heart Association or Canadian Cardiovascular Score of 4

Severe functional limitations

Cognitive impairment that impacts consenting ability

Significant language barrier

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual PREHAB

    Behavioral

    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 and/or online consults with participants will monitor the progression of the individual through the program, review patient materials, review medication changes, as well as provide recommendations to adopting a physically active lifestyle, diet, well-being, smoking, or other supports available to the patient. Medication changes are monitored by a nurse and any necessary medication recommendations involve the program's medical director, the patient's family physician, and TAVI team.

  • Standard care

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard CareActive comparator 1 intervention
Group B: Virtual PREHABExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CLSA-FI

Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)

Time frame
Baseline
2

CLSA-FI

Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)

Time frame
8-weeks preoperatively
3

CLSA-FI

Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)

Time frame
1-week preoperatively
4

CLSA-FI

Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)

Time frame
3-months postoperatively

Secondary outcomes

1

EQ-5D-5L health-related quality of life

Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)

Time frame
Baseline
2

EQ-5D-5L health-related quality of life

Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)

Time frame
8-weeks preoperatively
3

EQ-5D-5L health-related quality of life

Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)

Time frame
1-week preoperatively
4

EQ-5D-5L health-related quality of life

Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)

Time frame
3-months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

Source ClinicalTrials.gov
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