跳至主要内容
临床试验/NCT05617196
NCT05617196招募中不适用

Feasibility of a Virtually Delivered Preoperative Rehabilitation Program for Patients Awaiting TAVI to Reduce Frailty: The Virtual PREHAB Study

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
CLSA-FI

研究概览

简要总结

Nova Scotians are aging and many are becoming frailer. People with frailty are more likely to live in worse health and do not recover well from major events, such as open heart surgery. Many people are also too frail to receive open heart surgery. Less invasive procedures called transcatheter aortic valve implantation, or TAVI, are provided for the frailest patients. While TAVI is life-saving, frailer patients are less likely to survive in better health after their operation. Patients in Nova Scotia can also wait up to 3-6 months for their operation where they become frailer or can die before receiving TAVI. The investigators believe that it is important to support these individuals to improve their frailty and overall health before their operation.

Center-based cardiac rehabilitation is offered to patients after, but not before TAVI to improve their health. Center-based preoperative cardiac rehabilitation (i.e., PREHAB) can safely improve the function of frail patients who received open heart surgery. However, many patients cannot come to a center-based PREHAB because of transportation requirements to access the program. Another option is to support these patients with virtually delivered PREHAB, where they can stay in their homes. However, this possibility has not been studied.

For this study, virtual PREHAB will be delivered using the virtual cardiac rehabilitation program in Nova Scotia to patients before TAVI. This intervention will be delivered by healthcare providers who routinely care for TAVI patients, including a medical director, program lead, nurse, physiotherapist, and dietician. Ther goal of this study is to determine if it is feasible and safe to use virtual PREHAB to reduce frailty before TAVI. This research fits with Research Nova Scotia's priorities to improve patient outcomes in those with significant long-term health conditions, and to provide accessible, safe, and quality virtual healthcare to patients so they can thrive after their operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre
  • Informed written or verbal consent

排除标准

  • New York Heart Association or Canadian Cardiovascular Score of 4
  • Severe functional limitations
  • Cognitive impairment that impacts consenting ability
  • Significant language barrier
  • No internet or telephone access that precludes virtual PREHAB participation

结局指标

主要结局

CLSA-FI

时间窗: 3-months postoperatively

Canadian Longitudinal Study on Aging Frailty Index; range 0-1 (lower is better)

PFFS-FI

时间窗: 3-months postoperatively

Pictorial-Fit Frail Scale Frailty Index; range 0-1 (lower is better)

次要结局

  • Cardiac rehabilitation attendance(3-months postoperatively)
  • EQ-5D-5L health-related quality of life(3-months postoperatively)
  • VARC-3 Composite clinical end-points(30-days postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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