Aortic Valve Stenosis Clinical Trial
Official title:
The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
NCT number | NCT06040398 |
Other study ID # | 15474 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | March 31, 2024 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | March 31, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences (McMaster Children's Hospital and Hamilton General Hospital) | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | Edwards Lifesciences, McMaster University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | Adoption | Number of eligible patients who participate in the JUMPSTART program. | 14 days post-TAVR procedure. | |
Primary | Adoption | Number of eligible patients who participate in the JUMPSTART program. Target = 70% adoption rate. | 3 months post-TAVR procedure. | |
Secondary | 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. | 12 months (post-study start date). | |
Secondary | 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. | 3 months post-TAVR procedure. | |
Secondary | 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. | 14 days and 3 months post-TAVR procedure. | |
Secondary | 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. | 14 days and 3 months post-TAVR procedure. | |
Secondary | 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. | 14 days and 3 months post-TAVR procedure. | |
Secondary | 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. | Assessed at 4 months (post-study start date), 8 months, and 12 months. | |
Secondary | 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. | Assessed at 4 months (post-study start date), 8 months, and 12 months. |
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