Clinical trial NCT06040398: The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
Official title: The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
Keywords: early mobilization
exercise program
cardiac care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
name: McMaster University
First posted: 2023-09-15
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Effectiveness (quality of life)
timeFrame: Baseline and 3 months post-TAVR procedure.
measure: Adoption
timeFrame: 14 days post-TAVR procedure.
measure: Adoption
timeFrame: 3 months post-TAVR procedure.
Secondary outcomes:
measure: Reach
timeFrame: 12 months (post-study start date).
measure: Effectiveness (cardiac rehab attendance)
timeFrame: 3 months post-TAVR procedure.
measure: Effectiveness (acceptability)
timeFrame: 14 days and 3 months post-TAVR procedure.
measure: Effectiveness (feasibility)
timeFrame: 14 days and 3 months post-TAVR procedure.
measure: Adoption (barriers and facilitators)
timeFrame: 14 days and 3 months post-TAVR procedure.
measure: Implementation (fidelity)
timeFrame: Assessed at 4 months (post-study start date), 8 months, and 12 months.
measure: Maintenance
timeFrame: Assessed at 4 months (post-study start date), 8 months, and 12 months.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences (McMaster Children's Hospital and Hamilton General Hospital)
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences and McMaster University
name: Madhu K Natarajan, MD
role: PRINCIPAL_INVESTIGATOR
References: