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Virtual PREHAB Study for Patients Undergoing TAVI

Primary Purpose

Cardiovascular Diseases in Old Age, Frailty, TAVI

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual PREHAB
Standard care
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases in Old Age focused on measuring Frailty, Virtual PREHAB, Cardiac rehabilitation, TAVI

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard Care

    Virtual PREHAB

    Arm 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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    EQ-5D-5L health-related quality of life
    Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
    EQ-5D-5L health-related quality of life
    Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
    EQ-5D-5L health-related quality of life
    Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
    EQ-5D-5L health-related quality of life
    Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
    VARC-3 Composite clinical end-points
    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
    VARC-3 Composite clinical end-points
    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
    Cardiac rehabilitation attendance
    Percent of people attending cardiac rehabilitation

    Full Information

    First Posted
    October 26, 2022
    Last Updated
    November 14, 2022
    Sponsor
    Nova Scotia Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05617196
    Brief Title
    Virtual PREHAB Study for Patients Undergoing TAVI
    Official Title
    Feasibility of a Virtually Delivered Preoperative Rehabilitation Program for Patients Awaiting TAVI to Reduce Frailty: The Virtual PREHAB Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nova Scotia Health Authority

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases in Old Age, Frailty, TAVI
    Keywords
    Frailty, Virtual PREHAB, Cardiac rehabilitation, TAVI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care
    Arm Type
    Active Comparator
    Arm Title
    Virtual PREHAB
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual PREHAB
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard care
    Intervention Description
    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 Measure Information:
    Title
    CLSA-FI
    Description
    Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
    Time Frame
    Baseline
    Title
    CLSA-FI
    Description
    Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
    Time Frame
    8-weeks preoperatively
    Title
    CLSA-FI
    Description
    Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
    Time Frame
    1-week preoperatively
    Title
    CLSA-FI
    Description
    Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)
    Time Frame
    3-months postoperatively
    Title
    PFFS-FI
    Description
    Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
    Time Frame
    Baseline
    Title
    PFFS-FI
    Description
    Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
    Time Frame
    1-week preoperatively
    Title
    PFFS-FI
    Description
    Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
    Time Frame
    8-weeks preoperatively
    Title
    PFFS-FI
    Description
    Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)
    Time Frame
    3-months postoperatively
    Secondary Outcome Measure Information:
    Title
    EQ-5D-5L health-related quality of life
    Description
    Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
    Time Frame
    Baseline
    Title
    EQ-5D-5L health-related quality of life
    Description
    Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
    Time Frame
    8-weeks preoperatively
    Title
    EQ-5D-5L health-related quality of life
    Description
    Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
    Time Frame
    1-week preoperatively
    Title
    EQ-5D-5L health-related quality of life
    Description
    Euroqol-5 dimension-5 level health-related quality of life; range 5-25 (lower is better)
    Time Frame
    3-months postoperatively
    Title
    VARC-3 Composite clinical end-points
    Description
    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
    Time Frame
    Hospital discharge (assessed up to day 14)
    Title
    VARC-3 Composite clinical end-points
    Description
    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
    Time Frame
    30-days postoperatively
    Title
    Cardiac rehabilitation attendance
    Description
    Percent of people attending cardiac rehabilitation
    Time Frame
    3-months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Scott Kehler, PhD
    Phone
    902-494-2822
    Email
    scott.kehler@dal.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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