Prehabilitation for Aortic Aneurysm Surgery: Proof-of-concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intervention feasibility
研究概览
简要总结
This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program, a 6-week collaborative care intervention to help prepare individuals for repair of aortic aneurysms.
详细描述
This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program. Ready for Recovery is a 6-week collaborative care program to prepare individuals for surgical procedures to repair an aortic aneurysm. Participants will speak with a study trainer on the phone each week and will set goals related to physical activity, a healthy diet, and inspiratory muscle training. They also will be given resources to reduce stress, treat anxiety and depression (if present), and stop smoking, and the study team will make recommendations regarding medication adjustments to reduce complications after surgery. The primary outcome is feasibility (measured by percentage of phone sessions completed). Secondary outcomes include acceptability (measured by weekly 0-10 utility ratings) and preliminary impact on functional, psychological, and health behavior outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing elective aortic aneurysm repair (open or endovascular)
排除标准
- •Cognitive disturbance
- •Current pregnancy or plan to become pregnant prior to surgery
- •Inability to write/speak fluently in English
研究组 & 干预措施
Ready for Recovery
Participants in this arm will receive the Ready for Recovery intervention.
干预措施: Ready for Recovery (Behavioral)
结局指标
主要结局
Intervention feasibility
时间窗: Weekly over 6 weeks
Percentage of intervention phone sessions completed
次要结局
- Feasibility of data collection(Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge)
- Utility of the Ready for Recovery program(6 weeks)
- Change in physical function (PROMIS PF-20)(Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge)
研究者
Christopher Celano
Associate Director, Cardiac Psychiatry Research Program
Massachusetts General Hospital
