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

September 13, 2023 updated by: Madhu K. Natarajan, Hamilton Health Sciences Corporation
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Hamilton Health Sciences (McMaster Children's Hospital and Hamilton General Hospital)
        • Contact:
          • Administrative Office
          • Phone Number: 905-521-2100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness (quality of life)
Time Frame: Baseline and 3 months post-TAVR procedure.
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
Time Frame: 14 days post-TAVR procedure.
Number of eligible patients who participate in the JUMPSTART program.
14 days post-TAVR procedure.
Adoption
Time Frame: 3 months post-TAVR procedure.
Number of eligible patients who participate in the JUMPSTART program. Target = 70% adoption rate.
3 months post-TAVR procedure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reach
Time Frame: 12 months (post-study start date).
Assessed by dividing the total eligible number of TAVR patients who agree to enter the JUMPSTART program by the total eligible number of TAVR patients who underwent the TAVR procedure at the Hamilton General Hospital.
12 months (post-study start date).
Effectiveness (cardiac rehab attendance)
Time Frame: 3 months post-TAVR procedure.
Measurement of the percentage of post-TAVR patients who have attended a cardiac rehab orientation session by 3 months post-TAVR procedure.
3 months post-TAVR procedure.
Effectiveness (acceptability)
Time Frame: 14 days and 3 months post-TAVR procedure.
Acceptability will be measured by self-reported questionnaire in consenting participants, administered via telephone interview or online survey (REDCap). Participants are asked to provide their level of satisfaction with the exercise videos and instructional handout on a scale of 1-7, where 1 = very unsatisfied and 7 = very satisfied.
14 days and 3 months post-TAVR procedure.
Effectiveness (feasibility)
Time Frame: 14 days and 3 months post-TAVR procedure.
Feasibility will be measured by self-reported questionnaire in consenting participants, administered via telephone interview or online survey (REDCap). Participants are asked about ease in following the exercise videos, and challenges associated with doing the exercises.
14 days and 3 months post-TAVR procedure.
Adoption (barriers and facilitators)
Time Frame: 14 days and 3 months post-TAVR procedure.
Barriers and facilitators will be assessed by questionnaire administered via telephone interview or online survey (REDCap). No response scales are used, the data collected is qualitative in nature. Implementation strategies will be tailored to these barriers and facilitators using an iterative process.
14 days and 3 months post-TAVR procedure.
Implementation (fidelity)
Time Frame: Assessed at 4 months (post-study start date), 8 months, and 12 months.
Meetings/focus groups with research team and hospital staff to review whether implementation has taken place as planned (e.g., fidelity of the recruitment process, data collection), and to discuss pre-discharge testing and whether patients are given JUMPSTART materials both at the pre-TAVR clinic and prior to discharge.
Assessed at 4 months (post-study start date), 8 months, and 12 months.
Maintenance
Time Frame: Assessed at 4 months (post-study start date), 8 months, and 12 months.
Meetings/focus groups with research team to review study participation rates and to discuss barriers to participation. Program sustainability and plans for imbedding the program into routine care/practice will also be discussed.
Assessed at 4 months (post-study start date), 8 months, and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamilton Health Sciences Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McMaster University
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Madhu K Natarajan, MD, Hamilton Health Sciences and McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15474

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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