Clinical trial NCT04823286: Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform
Official title: REVID +: Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform (GoodRENal.eu)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Hemodialysis-Induced Symptom
Chronic Kidney Diseases
Keywords: exercise
physical function
health related quality of life
nutrition
psychological wellbeing
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Hospital de Manises
name: Universitat Politècnica de València
name: University of Valencia
name: Karolinska Institutet
name: Skane University Hospital
name: KU Leuven
name: Aristotle University Of Thessaloniki
First posted: 2021-03-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two groups, intradialysis virtual reality platform or usual care
Primary purpose: TREATMENT

Brief summary: 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:

1. A didactic content in a modular platform to create an educational program for integrated treatments in patients with dialysis
2. A guideline to promote healthy lifestyles among dialysis patients for health care providers
3. A guideline to promote e healthy lifestyles among dialysis patients for patients and formal - nonformal carers

Detailed description: 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.

VR exercise has been successfully implemented in neuro-rehabilitation, resulting in better balance, gait, and mobility in cerebrovascular accidents, multiple sclerosis, Guillain-Barre syndrome, and Parkinson's disease. Few studies have explored the impact of VR exercise in renal rehabilitation. Three of the partners (Universidad Cardenal Herrera-CEU, Universitat Politècnica de Valéncia, and Hospital de Manises) have implemented two randomized trials of non-immersive VR exercise intradialysis. Currently, those partners are developing a third trial with this technology and they have verified that this type of exercise has good tolerance and high adherence rates. Additionally, it has a positive impact on strength, functional capacity, physical activity level, and health-related quality of life.

Until now, the most traditional way to assess and implement psychological and psycho-educative treatments has been 'face to face'. Nevertheless, more than 50% of people suffering from depression are not being treated appropriately. This is why alternative treatment models to assess and treat are being implemented, and technology (as the internet) is an option to increase the number of patients that can be treated. Additionally, few studies have explored technology as a means to educate renal patients regarding nutrition or psychological health.

Thus, the hypothesis of the present study is that a health virtual platform designed for holistic treatment of patients undertaking hemodialysis will result in health benefits for this cohort, regarding physical activity, nutritional and psychological health. The platform will be designed according to the aims highlighted by experts, barriers, and needs of end-stage CKD patients and their caregivers. As mentioned above, end-stage chronic kidney disease patients have high comorbidity, malnutrition, sedentarism, low health-related quality of life, low physical function, frailty, and high dependency levels. So they rely on non-formal caregivers for their activities of daily living. This cohort presents high anxiety and depression levels and the combination of somatic disease plus depression results in higher symptoms, higher comorbidity, higher health resources, and worst quality of life. Besides, there is a bidirectional relationship between depression and disease, and depression is associated with lower adherence to medical treatment.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary outcomes:
measure: Change from baseline health-related quality of life assessed by the Short Form 36 questionnaire at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline stance from a chair capacity assessed by the sit to stand 10 at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline usual gait speed assessed by a 4 meters gait speed test at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline handgrip strength assessed by a handgrip dinamometer at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline lower limbs strength assessed by a dinamometer at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline physical activity level assessed by the human activity profile questionnaire, average activity score at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline physical activity level assessed by the international physical activity questionnaire at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Percentage of sessions performed from te sessions offered to measure adherence to the educational program
timeFrame: After 12 weeks of intervention
measure: Healthcare resources expenditure and costs
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline lean body mass assessed by the bioimpedance spectroscopy at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline qualitative assessment in food intake assessed by the Short form food questionnaire at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline nutritional status assessed by the 7 point Subjective Global Assessment at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline cognitive function assessed by the Mini-mental State at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline Anxiety assessed by the Hospital Anxiety and Depression Scale at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline positive and negative emotions assessed by Positive and Negative Affect Schedule Scale (PANAS) at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline depression assessed by the Beck Depression Inventory (BDI) at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline anxiety assessed by the State Trait Anxiety Inventory (STAI) at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline perceived stress assessed by the Perceived Stress Scale (PSS) at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline cognitive state assessed by the Montreal Cognitive Assessment (MoCA)at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline attention level assessed by the Trail Making Test (TMT) at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
measure: Change from baseline memory assessed by the Wechsler-IV Memory Scale at 12 weeks
timeFrame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Valencia
country: Spain
facility: Universitat de Valencia
city: Valencia
country: Spain
facility: Universitat Politécnica de Valéncia
city: Lund
country: Sweden
facility: Skane Univeristy Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Universidad CEU Cardenal Herrera, UCH CEU
name: Eva SEGURA-ORTÍ
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23.
citation: Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
citation: Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
citation: Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
citation: Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527.
citation: Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.