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

NCT06040398 | Unknown

• 1 other identifier: 15474
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Keywords

early mobilization; exercise program; cardiac care

Outcome Measures

Primary Outcomes (3)

• Effectiveness (quality of life)

  Changes in Toronto Aortic Stenosis QoL Questionnaire (TASQ) scores will be compared among study participants who did the JUMPSTART program, and those that didn't. The TASQ consists of 16 statements. Most statements are answered via 7-point Likert scale, where a higher score represents worse outcomes.

  Baseline and 3 months post-TAVR procedure.

• Adoption

  Number of eligible patients who participate in the JUMPSTART program.

  14 days post-TAVR procedure.

• Adoption

  Number of eligible patients who participate in the JUMPSTART program. Target = 70% adoption rate.

  3 months post-TAVR procedure.

Secondary Outcomes (7)

• Reach

  12 months (post-study start date).

• Effectiveness (cardiac rehab attendance)

  3 months post-TAVR procedure.

• Effectiveness (acceptability)

  14 days and 3 months post-TAVR procedure.

• Effectiveness (feasibility)

  14 days and 3 months post-TAVR procedure.

• Adoption (barriers and facilitators)

  14 days and 3 months post-TAVR procedure.

Study Arms (1)

TAVR Patients

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

Behavioral: JUMPSTART exercise program

Interventions

JUMPSTART exercise program 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.

TAVR Patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of post-TAVR patients is growing larger and ranges in age from 65 to 95 years.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Edwards Lifesciences: collaborator
• McMaster University: collaborator

Study Sites (1)

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

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Madhu K Natarajan, MD

  Hamilton Health Sciences and McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marija Corovic, MPH

CONTACT

(905) 525-9140; corovicm@mcmaster.ca

Karen Mosleh, MSc

CONTACT

(905) 525-9140; spithokd@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional and Structural Cardiologist; Professor, McMaster University

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: September 15, 2023
• Study Start: March 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

CA (1)