The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Effectiveness (quality of life)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Effectiveness (quality of life)
时间窗: 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
时间窗: 3 months post-TAVR procedure.
Number of eligible patients who participate in the JUMPSTART program. Target = 70% adoption rate.
次要结局
- Effectiveness (cardiac rehab attendance)(3 months post-TAVR procedure.)
- Maintenance(Assessed at 4 months (post-study start date), 8 months, and 12 months.)
- Effectiveness (feasibility)(14 days and 3 months post-TAVR procedure.)
- Reach(12 months (post-study start date).)
- Effectiveness (acceptability)(14 days and 3 months post-TAVR procedure.)
- Adoption (barriers and facilitators)(14 days and 3 months post-TAVR procedure.)
- Implementation (fidelity)(Assessed at 4 months (post-study start date), 8 months, and 12 months.)
研究者
Madhu K. Natarajan
Interventional and Structural Cardiologist; Professor, McMaster University
Hamilton Health Sciences Corporation