Heal-Me PiONEeR (Personalized Online Nutrition and Exercise Routines) - Reconnecting Vulnerable Outpatients With Multidisciplinary Care - a Randomized Controlled Trial Assessing 3 Levels of Online Programming in the Time of COVID
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Lower Extremity Functional Scale (LEFS)
研究概览
简要总结
The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.
Participants will be randomized to one of three groups: (i) standard care, (ii) a personnel-light app-based intervention, (iii) a personnel-intensive app-based intervention. Participants randomized to standard care will receive exercise and nutrition resources as well as a Garmin watch. Participants in the experimental groups will receive standard care, plus a 12-week multidisciplinary app-based personalized program involving 12 weeks of exercise programming and 10-weeks of nutrition programming. Participants in study group 3 will receive additional one-on-one care.
The Research Ethics Board at the University of Alberta has approved this study. The protocol will measure patient-related outcome measures including physical function, quality of life, social isolation, and anxiety, as well as measures of acceptability and cost. 216 participants will take part in this study (n=72 per arm).
Analyses: fitness testing and patient-reported outcomes will be administered before and after the intervention. Fitness and patient-reported outcomes will be compared using linear mixed models with random effects. App acceptability will be compared between groups using Chi-Square.
详细描述
INTRODUCTION:
COVID-19 related social distancing have a profound impact on vulnerable people living with chronic conditions, including cancer and organ failure. Pre-pandemic, many of these patients relied on and benefited from multidisciplinary supports and structured programming to maintain well-being and function. Many of these in-person supports are not currently available, which has disconnected these patients from the care they need to stay well.
Virtual modalities are a promising solution that allow multidisciplinary programs (i.e. exercise and nutrition) to continue to deliver support for these patients when social distancing doesn't allow these programs to run in-person. However, it's currently unclear whether virtual programming is acceptable in these populations, and what level of support is best in terms of benefits and costs.
The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.
OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •≥ 18 years of age
- •In one of the following 3 disease groups:
- •Cancer survivor who has completed treatment or is receiving maintenance therapy
- •Patient who is currently post-transplantation from liver or lung transplantation
- •Patient with chronic lung disease who may or may not be listed for organ transplantation
- •Previous enrolment in exercise rehabilitation program (i.e. rehabilitation "graduate")
- •Access to an Internet connected device with video and audio capabilities
排除标准
- •Compassionate care
- •Unsafe to participate in a virtual exercise program
- •Unable to provide informed consent
结局指标
主要结局
Lower Extremity Functional Scale (LEFS)
时间窗: 12 Weeks
The difference in the pre- vs post-intervention change in LEFS score between groups (score range: 0-80, higher scores indicate higher function)
次要结局
- Resilience (10-Item Connor Davidson Resilience Scale)(12 Weeks)
- Sit-and-Reach(12 Weeks)
- Overall Well-Being (The World Health Organization-5 [WHO-5] Well-Being Index)(12 Weeks)
- General health-related quality of life (5-Level EQ-5D [EQ-5D-5L])(12 Weeks)
- Timed Sit-to-Stand (60 & 30 seconds)(12 Weeks)
- Timed One-Legged Stance(12 Weeks)
- Step Count & Activity Minutes(12 Weeks)
- Upper Extremity Functional Index (UEFI)(12 weeks)
- 2-Minute Step Test (2MST)(12 Weeks)
- General health-related quality of life (36-Item Short Form Survey [SF-36])(12 Weeks)