Aortic Valve StenosisNCT06040398
The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- What is being tested?
- JUMPSTART exercise program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The population of post-TAVR patients is growing larger and ranges in age from 65 to 95 years.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences (McMaster Children's Hospital and Hamilton General Hospital)
Hamilton, Ontario
Administrative Office, 905-521-2100
About this study
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.
Read the 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.
- Being tested
- JUMPSTART exercise program
- Keywords
- early mobilization, exercise program, cardiac care
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUMPSTART exercise programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TAVR Patients | All outpatients undergoing TAVR and managed through the overnight-model pathway at the Hamilton General Hospital will be eligible for participation. Receives: Behavioral: JUMPSTART exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months post-TAVR procedure.
Adoption
Number of eligible patients who participate in the JUMPSTART program.
Measured: 14 days post-TAVR procedure.
Adoption
Number of eligible patients who participate in the JUMPSTART program. Target = 70% adoption rate.
Measured: 3 months post-TAVR procedure.
Secondary outcomes (7)
Reach
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.
Measured: 12 months (post-study start date).
Effectiveness (cardiac rehab attendance)
Measurement of the percentage of post-TAVR patients who have attended a cardiac rehab orientation session by 3 months post-TAVR procedure.
Measured: 3 months post-TAVR procedure.
Effectiveness (acceptability)
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.
Measured: 14 days and 3 months post-TAVR procedure.
Effectiveness (feasibility)
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.
Measured: 14 days and 3 months post-TAVR procedure.
Adoption (barriers and facilitators)
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.
Measured: 14 days and 3 months post-TAVR procedure.
Implementation (fidelity)
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.
Measured: Assessed at 4 months (post-study start date), 8 months, and 12 months.
Maintenance
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.
Measured: Assessed at 4 months (post-study start date), 8 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences, McMaster University
- Responsible party
- Principal investigator, Madhu K. Natarajan, Hamilton Health Sciences Corporation
- Investigators
- Madhu K Natarajan, MD, Principal investigator, Hamilton Health Sciences and McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040398
- Sponsor's protocol ID
- 15474
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
- ClinicalTrials.gov ID
- NCT06040398
- Acronym / sponsor ID
- 15474
- Keywords
- early mobilization, exercise program, cardiac care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Edwards Lifesciences, McMaster University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR Patients | – | Behavioral: JUMPSTART exercise programAll outpatients undergoing TAVR and managed through the overnight-model pathway at the Hamilton General Hospital will be eligible for participation. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The population of post-TAVR patients is growing larger and ranges in age from 65 to 95 years.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUMPSTART exercise programThe 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. | Behavioural | TAVR Patients |
Primary outcome
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.
Adoption
Time frame: 14 days post-TAVR procedure.
Number of eligible patients who participate in the JUMPSTART program.
Adoption
Time frame: 3 months post-TAVR procedure.
Number of eligible patients who participate in the JUMPSTART program. Target = 70% adoption rate.
7 secondary outcomes
Reach
Time frame: 12 months (post-study start date).
Effectiveness (cardiac rehab attendance)
Time frame: 3 months post-TAVR procedure.
Effectiveness (acceptability)
Time frame: 14 days and 3 months post-TAVR procedure.
Effectiveness (feasibility)
Time frame: 14 days and 3 months post-TAVR procedure.
Adoption (barriers and facilitators)
Time frame: 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.
Maintenance
Time frame: Assessed at 4 months (post-study start date), 8 months, and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhu K Natarajan, MD principal investigator
Hamilton Health Sciences and McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marija Corovic, MPH ((905) 525-9140, corovicm@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (quality of life) (time frame: Baseline and 3 months post-TAVR procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.