The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge

NCT ID: NCT06040398

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-31

Brief Summary

A virtual, self-directed, and tailored early mobilization program called JUMPSTART, that aims to bridge cardiac rehabilitation intake for post-TAVR patients has been developed at the Hamilton General Hospital. The program includes a series of exercise videos at varying levels of intensity, designed for patients to follow at home, post-discharge. JUMPSTART is currently being offered as part of clinical care. In this new pilot study, the study team plans to develop and test new strategies to optimize recruitment and participation, develop additional JUMPSTART materials and evaluate outcomes through follow-up surveys and registry/administrative data at Hamilton General Hospital.

Detailed Description

Post-TAVR patients who have successfully completed a pre-discharge ambulation assessment and are deemed eligible for discharge will be eligible to participate. Potential participants will be introduced to the study in the pre-TAVR clinic by the nurse practitioner or their delegate. Participants who agree to be contacted for research purposes will provide written consent in the pre-TAVR clinic when they meet with the nurse practitioner. Confirmation of eligibility for the research study will be conducted post-TAVR by the nurse practitioner. The JUMPSTART program will be offered to all eligible patients as part of standard clinical care, regardless of their consent to participate in the research study. No data will be collected for the purposes of the research study from patients who do not provide consent. The primary outcomes will be adoption (the number of eligible post-TAVR patients who participate in the JUMPSTART early mobilization program), and a preliminary comparison of quality of life (measured using the Toronto Aortic Stenosis Quality of Life Questionnaire) between people who do and do not participate in the JUMPSTART program.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TAVR Patients

All outpatients undergoing TAVR and managed through the overnight-model pathway at the Hamilton General Hospital will be eligible for participation.

JUMPSTART exercise program

Intervention Type: BEHAVIORAL

The intervention is an early mobilization protocol (JUMPSTART). Four interactive exercise videos, at different intensity levels, include a variety of stretches and exercises designed to improve the full body mobilization of post-TAVR patients. Videos have been developed in consultation with a physiotherapist and cardiac rehabilitation specialist and have been piloted for initial acceptability by patients at the Hamilton General Hospital. The videos will be freely accessible to all eligible patients and their caregivers (regardless of participation in the research study) online (www.hhscebi.ca/projects/jumpstart). A written version of the exercise program, with photographs and detailed instructions, will also be made available. Additional exercise videos will be developed based on patients' needs and feedback received.

Interventions

JUMPSTART exercise program

The intervention is an early mobilization protocol (JUMPSTART). Four interactive exercise videos, at different intensity levels, include a variety of stretches and exercises designed to improve the full body mobilization of post-TAVR patients. Videos have been developed in consultation with a physiotherapist and cardiac rehabilitation specialist and have been piloted for initial acceptability by patients at the Hamilton General Hospital. The videos will be freely accessible to all eligible patients and their caregivers (regardless of participation in the research study) online (www.hhscebi.ca/projects/jumpstart). A written version of the exercise program, with photographs and detailed instructions, will also be made available. Additional exercise videos will be developed based on patients' needs and feedback received.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Outpatients who have undergone a TAVR procedure at the Hamilton General Hospital
• Patients who are managed through the overnight-model pathway
• Patients who successfully completed ambulation assessment
• Patients who are deemed eligible for discharge

Exclusion Criteria

• Patients who are hospitalized after the procedure (inpatients)
• Patients who had an axillary approach for TAVR
• Patients who had a pacemaker temporarily left in at the end of case, and
• Patients who received a permanent pacemaker in the last month

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Madhu K. Natarajan

Interventional and Structural Cardiologist; Professor, McMaster University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madhu K Natarajan, MD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences and McMaster University

Locations

Hamilton Health Sciences (McMaster Children's Hospital and Hamilton General Hospital)

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marija Corovic, MPH

Role: CONTACT

corovicm@mcmaster.ca

(905) 525-9140

Karen Mosleh, MSc

Role: CONTACT

spithokd@mcmaster.ca

(905) 525-9140

Facility Contacts

Administrative Office

Role: primary

905-521-2100

Other Identifiers

15474

Identifier Type: -

Identifier Source: org_study_id