Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform

Chronic Kidney Diseases Clinical Trial

— GoodRENal  

Official title:

REVID +: Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform (GoodRENal.eu)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823286
• Other study ID #: 2020-064-1
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Cardenal Herrera University
• Contact: Eva SEGURA-ORTÍ, PhD
• Phone: 00 34 671580094
• Email: eva.segura[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• End Stage Renal Disease
• Hemodialysis-Induced Symptom
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• Virtual reality health platform during hemodialysis
Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis. The game will also aim at providing nutritional advice, and improving psychological wellbeing and cognitive function.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven
Greece	Aristotle University of Thessaloniki	Thessaloníki
Spain	Hospital de Manises	Manises	Valencia
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Universitat de Valencia	Valencia
Spain	Universitat Politécnica de Valéncia	Valencia
Sweden	Skane Univeristy Hospital	Lund
Sweden	Karolinska Institute	Stockholm

Sponsors (8)

Lead Sponsor	Collaborator
Cardenal Herrera University	Aristotle University Of Thessaloniki, Hospital de Manises, Karolinska Institutet, KU Leuven, Skane University Hospital, Universitat Politècnica de València, University of Valencia

Countries where clinical trial is conducted

Belgium,  Greece,  Spain,  Sweden, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks	More meters walked in 6 minutes mean a better walking capacity	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline health-related quality of life assessed by the Short Form 36 questionnaire at 12 weeks	The short form 36 gives data on 8 subscales and 2 components, higher score mean better health-related quality of life The scores range from 0 to 100, with 100 indicating optimal health and 0 reflecting very poor health.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline stance from a chair capacity assessed by the sit to stand 10 at 12 weeks	Time in seconds to perform 10 sit to stand repetitions. A decrease in the time to perform the test means better functional capacity to stand up from a chair	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline usual gait speed assessed by a 4 meters gait speed test at 12 weeks	Speed in m/s to cover 4 meters at normal speed. An increase in speed to perform the test means better gait speed	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline handgrip strength assessed by a handgrip dinamometer at 12 weeks	Bilateral handgrip strength measured in kilograms. An increase in handgrip strength means better strength	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline lower limbs strength assessed by a dinamometer at 12 weeks	Bilateral lower limbs muscle strength measured in kilograms. An increase in strength means better strength	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline physical activity level assessed by the human activity profile questionnaire, average activity score at 12 weeks	The average activity score of the human activity profile questionnaire ranges from 0 to 94. . A higher score means a higher physical activity level	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline physical activity level assessed by the international physical activity questionnaire at 12 weeks	The score of the international physical activity questionnaire will be recorded in MET-minutes/week. A higher score means a higher physical activity level	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Percentage of sessions performed from te sessions offered to measure adherence to the educational program	Calculation will be the result of sessions performed/sessions offered	After 12 weeks of intervention
Secondary	Healthcare resources expenditure and costs	Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline lean body mass assessed by the bioimpedance spectroscopy at 12 weeks	Lean body mass is a surrogate of muscle mass in kilograms. Increase in lean body mass means increase in muscle mass	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline qualitative assessment in food intake assessed by the Short form food questionnaire at 12 weeks	Qualitative assessment of food intake Short form food questionnaire. Improvement in the dietary quality	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline nutritional status assessed by the 7 point Subjective Global Assessment at 12 weeks	7 point subjective global assessment scores from 1 to 7, the higher the score the better nutritional status	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline cognitive function assessed by the Mini-mental State at 12 weeks	The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline Anxiety assessed by the Hospital Anxiety and Depression Scale at 12 weeks	Scores obtained between 0 and 21. The higher the score obtained, the higher the level of anxiety and depression.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline positive and negative emotions assessed by Positive and Negative Affect Schedule Scale (PANAS) at 12 weeks	It includes 2 subscales (positive affect and negative affect) with 10 items each. Each subscale can contain scores between 10 and 50. The higher the score obtained, the greater the presence of a particular affect.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline depression assessed by the Beck Depression Inventory (BDI) at 12 weeks	The scores range from 0 to 63 points. The higher the score, the greater the severity of depressive symptoms. Four groups are established according to the total score: 0-13, minimal depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline anxiety assessed by the State Trait Anxiety Inventory (STAI) at 12 weeks	Scale composed of 2 subscales. The range of scores for both subscales is between 0 and 60 points so that higher scores reflect greater anxiety.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline perceived stress assessed by the Perceived Stress Scale (PSS) at 12 weeks	Scores obtained in a range of 0 to 56 points. The higher the score obtained, the higher the level of perceived stress.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline cognitive state assessed by the Montreal Cognitive Assessment (MoCA)at 12 weeks	Scores on the MoCA assessment range from 0 to 30. A score of 26 and above is considered normal.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline attention level assessed by the Trail Making Test (TMT) at 12 weeks	Scoring is based on time taken to complete the test, with lower scores being better.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary	Change from baseline memory assessed by the Wechsler-IV Memory Scale at 12 weeks	The correction system allows obtaining scalar scores, indices, centiles and confidence intervals, in order to achieve a more flexible interpretation. It is interpreted on the basis of scales. The Spanish scales have been elaborated from a sample of almost 900 subjects aged between16 and 90 years.	Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention