Virtual PREHAB Study for Patients Undergoing TAVI

NCT05617196 | Recruiting

• 1 other identifier: NS-NHIG-2021-1905
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases in Old Age; Frailty; TAVI

Keywords

Frailty; Virtual PREHAB; Cardiac rehabilitation; TAVI

Outcome Measures

Primary Outcomes (8)

• CLSA-FI

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

  Baseline

• CLSA-FI

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

  8-weeks preoperatively

• CLSA-FI

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

  1-week preoperatively

• CLSA-FI

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

  3-months postoperatively

• PFFS-FI

  Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)

  Baseline

• PFFS-FI

  Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)

  1-week preoperatively

• PFFS-FI

  Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)

  8-weeks preoperatively

• PFFS-FI

  Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)

  3-months postoperatively

Secondary Outcomes (7)

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

  Baseline

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

  8-weeks preoperatively

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

  1-week preoperatively

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

  3-months postoperatively

• VARC-3 Composite clinical end-points

  Hospital discharge (assessed up to day 14)

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Behavioral: Standard care

Virtual PREHAB

EXPERIMENTAL

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.

Behavioral: Virtual PREHAB

Interventions

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.

Virtual PREHAB

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.

Standard Care

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B4E 0H4, Canada

RECRUITING

MeSH Terms

Conditions

Frailty

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Scott Kehler, PhD

CONTACT

902-494-2822; scott.kehler@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 15, 2022
• Study Start: January 5, 2023
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)