REVID +: Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform (GoodRENal.eu)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks
研究概览
简要总结
There is wide evidence regarding the weak points of end-stage Chronic kidney disease (CKD) patients in hemodialysis, and they include three intervention aspects: exercise, nutrition and psychological support. Evidence shows that exercise for patients in hemodialysis results in increased survival rate, functional capacity, strength and health-related quality of life.
Additionally, different studies have shown the benefits of psychological interventions and the positive effect of educational programs on nutritional care for patients in hemodialysis.
Despite the well-known benefits of exercise, this kind of programs are not being implemented in the routine clinical care of hemodialysis patients.
Thus, the GoodRENal project aims to promote healthy lifestyles among dialysis patients in a holistic approach that combines exercise, nutrition and psychological wellbeing plus cognitive functioning addressing adult learners. The project will, in phase 1, explore barriers and facilitators of patients, carers and health professionals towards healthy lifestyle (physical activity, nutrition and psychological well being). In phase 2, the project will develop a health virtual platform including these three dimensions of cares. In summary, the project outputs will be:
- A didactic content in a modular platform to create an educational program for integrated treatments in patients with dialysis
- A guideline to promote healthy lifestyles among dialysis patients for health care providers
- A guideline to promote e healthy lifestyles among dialysis patients for patients and formal - nonformal carers
详细描述
CKD stage 5D, has a high incidence, 100-200 people per million, and high prevalence, 750-1500 per million. More than 40-50% are above 65 years old, with a lower rate in women but with higher frailty than men. This cohort presents high comorbidity, malnutrition, sedentary behavior, low health-related quality of life, frailty and high dependency levels. Mortality risk is close to 15% per year. Cardiovascular disease is the main cause of death in end-stage CKD. It is also a high risk factor for peripheral artery disease and lower limbs amputation.
Supporting this cohort results in high direct and indirect costs. Additionally, these patients present high anxiety and depression rates. Comorbidity between depression and somatic illness leads to a significant increase of the illness load since there is higher symptomatology, higher morbidity, higher health costs, and worse functioning and quality of life. Current evidence suggests a bidirectional relationship between depression and medical illness. Mechanisms suggested explaining this complex relationship would include both biological and behavioral aspects. Depression is also associated with the worst adherence to treatment of comorbid patients.
There is wide evidence regarding the weak points of end-stage CKD patients in hemodialysis, and they include three intervention aspects: exercise, nutrition and psychological support. Evidence shows that exercise for patients in hemodialysis results in increased survival rate, functional capacity, strength, and health-related quality of life. Additionally, different studies have shown the benefits of psychological interventions and the positive effect of educational programs on nutritional care for patients in hemodialysis. Several combined interventions have been implemented leading to heterogeneous results.
Despite the well-known benefits of exercise, this kind of programs are not being implemented in the routine clinical care of hemodialysis patients. Patients' lack of interest regarding participation in exercise programs, time constraints, and lack of knowledge by health professionals at the hemodialysis units, are some of the factors underpinning the low implementation rate of intradialysis exercise programs.
Virtual reality (VR) refers to computer-generated interactive simulation that offers users the opportunity to participate in environments that look like objects and events of the real world.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
A team of assessors, different to the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on hemodialysis medically stable
- •Ability to walk to walk at least a few steps, even if walking aids like canes or a walker ar needed
- •Life expectancy greater than 6 months
排除标准
- •Myocardial infarction in the previous 6 weeks
- •Angina unstable on exercise or at rest
- •Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia.
- •Life expectancy less than 6 months
- •Cognitive impairment
- •Language barriers
- •Illiteracy
研究组 & 干预措施
Virtual reality health platform during hemodialysis
During 12 weeks subjects will use a VR platform during hemodialysis. The intervention will be virtual reality exercise, nutritional advice and psychological wellbeing support plus cognitive training.
干预措施: Virtual reality health platform during hemodialysis (Other)
Control group-usual care
During 12 weeks subjects will carry on with the usual care in the hemodialysis unit
结局指标
主要结局
Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks
时间窗: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
More meters walked in 6 minutes mean a better walking capacity
次要结局
- Change from baseline usual gait speed assessed by a 4 meters gait speed test at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline lower limbs strength assessed by a dinamometer at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline physical activity level assessed by the international physical activity questionnaire at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline cognitive function assessed by the Mini-mental State at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline health-related quality of life assessed by the Short Form 36 questionnaire at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline stance from a chair capacity assessed by the sit to stand 10 at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline handgrip strength assessed by a handgrip dinamometer at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Percentage of sessions performed from te sessions offered to measure adherence to the educational program(After 12 weeks of intervention)
- Change from baseline physical activity level assessed by the human activity profile questionnaire, average activity score at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Healthcare resources expenditure and costs(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline depression assessed by the Beck Depression Inventory (BDI) at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline qualitative assessment in food intake assessed by the Short form food questionnaire at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline perceived stress assessed by the Perceived Stress Scale (PSS) at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline cognitive state assessed by the Montreal Cognitive Assessment (MoCA)at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline lean body mass assessed by the bioimpedance spectroscopy at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline nutritional status assessed by the 7 point Subjective Global Assessment at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline Anxiety assessed by the Hospital Anxiety and Depression Scale at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline anxiety assessed by the State Trait Anxiety Inventory (STAI) at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline positive and negative emotions assessed by Positive and Negative Affect Schedule Scale (PANAS) at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline attention level assessed by the Trail Making Test (TMT) at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
- Change from baseline memory assessed by the Wechsler-IV Memory Scale at 12 weeks(Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention)
研究者
Eva Segura Ortí
Professor
Cardenal Herrera University