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Comparison of physical activity and quality of life in home haemodialysis (HHD) patients versus conventional in-centre haemodialysis (ICHD) patients: the observational, longitudinal, prospective, international, multicentric SeCoIA study protocol.

ABSTRACT: BACKGROUND:Home haemodialysis (HHD), has shown improved clinical outcomes, as well as a better quality of life, compared to conventional in-centre haemodialysis (ICHD) but still has a global low prevalence among end-stage renal disease patients. Haemodialysis (HD) patients tend to be sedentary but only few studies, mainly in North American ICHD patients, have evaluated the level of activity in HD patients. METHODS:SeCoIA is an observational, longitudinal, prospective, international, multicentric, study, conducted in metropolitan France and Belgium. The main objective of the study is to quantify the physical activity measured by the total daily number of steps, in HHD patients compared to ICHD patients. The SeCoIA study will include 80 HHD patients and 80 ICHD patients,. Secondary objectives will be to characterize the HHD population and to confirm HHD efficiency on clinical parameters, as well as quality of life (QoL), in current practice. Physical activity will be measured by a 3-axis accelerometer. Accelerometers have been shown to provide accurate information, on both physical activity and sedentary behaviour. Patients will be instructed to wear the device and complete a patient diary 7 consecutive days after inclusion and the first week of each month for 12?months. Decision to undergo HDD or ICHD is independent of the study and follow-up frequency remains at the discretion of the physician/centre. QoL and quality of sleep will be respectively assessed by the Kidney Disease Quality of Life 1.2 (KDQOL™) and the Pittsburg Sleep Quality index (PSQI) questionnaires at inclusion, 6- and 12-month visits. Patients presenting a restless leg syndrome (RLS) will also complete the International Restless Legs Syndrome rating scale (IRLS) questionnaire. DISCUSSION:The SeCoIA study will be the first large cohort study (160 patients) evaluating physical activity, objectively measured with a 3-axis accelerometer, in HHD versus ICHD patients. The present study will also include a comparison of QoL with a focus on RLS between HHD and ICHD. It is anticipated that HHD patients will have an improved physical activity and QoL which should encourage physicians to further promote HHD. TRIAL REGISTRATION:Clinical trial NCT03737578 study registered on November 9, 2018 (Retrospectively registered).

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PROVIDER: S-EPMC7682091 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Comparison of physical activity and quality of life in home haemodialysis (HHD) patients versus conventional in-centre haemodialysis (ICHD) patients: the observational, longitudinal, prospective, international, multicentric SeCoIA study protocol.

Target Natalia N Courivaud Cécile C Michel Pierre Antoine PA Daoud Salima S Thomas Michel M

BMC nephrology 20201123 1

<h4>Background</h4>Home haemodialysis (HHD), has shown improved clinical outcomes, as well as a better quality of life, compared to conventional in-centre haemodialysis (ICHD) but still has a global low prevalence among end-stage renal disease patients. Haemodialysis (HD) patients tend to be sedentary but only few studies, mainly in North American ICHD patients, have evaluated the level of activity in HD patients.<h4>Methods</h4>SeCoIA is an observational, longitudinal, prospective, internationa ...[more]

PMID: 33225917

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Project description:To evaluate patient experiences of specific aspects of haemodialysis care across several countries.Cross-sectional survey using the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) questionnaire.Haemodialysis clinics within a single provider in Europe and South America.2748 adults treated in haemodialysis.The primary outcome was patient satisfaction with overall care. Secondary outcomes included patient experiences of individual aspects of dialysis care.2145 (78.1%) adults responded to the questionnaire. Fewer than half (46.5% (95% CI 44.5% to 48.6%)) rated their overall care as excellent. Global perceptions of care were uninfluenced by most respondent characteristics except age and depressive symptoms; older respondents were less critical of their care (adjusted OR for excellent rating 1.44 (1.01 to 2.04)) and those with depressive symptoms were less satisfied (0.56 (0.44 to 0.71)). Aspects of care that respondents most frequently ranked as excellent were staff attention to dialysis vascular access (54% (52% to 56%)); caring of nurses (53% (51% to 55%)); staff responsiveness to pain or discomfort (51% (49% to 53%)); caring, helpfulness and sensitivity of dialysis staff (50% (48% to 52%)); and ease of reaching dialysis staff by telephone (48% (46% to 50%)). The aspects of care least frequently ranked as excellent were information provided when choosing a dialysis modality (23% (21% to 25%)), ease of seeing a social worker (28% (24% to 32%)), information provided about dialysis (34% (32% to 36%)), accuracy of information from nephrologist (eg, about prognosis or likelihood of a kidney transplant; 37% (35% to 39%)) and accuracy of nephrologists' instructions (39% (36% to 41%)).Haemodialysis patients are least satisfied with the complex aspects of care. Patients' expectations for accurate information, prognosis, the likelihood of kidney transplantation and their options when choosing dialysis treatment need to be considered when planning healthcare research and practices.

Project description:BackgroundIntroducing a de-novo home haemodialysis (HHD) program often raises safety concerns as errors could potentially lead to serious adverse events. Despite the complexity of performing haemodialysis at home without the supervision of healthcare staff, HHD has a good safety record. We aim to pre-emptively identify and reduce the risks to our new HHD program by risk assessment and using failure mode and effects analysis (FMEA) to identify potential defects in the design and planning of HHD.MethodsWe performed a general risk assessment of failure during transitioning from in-centre to HHD with a failure mode and effects analysis focused on the highest areas of failure. We collaborated with key team members from a well-established HHD program and one HHD patient. Risk assessment was conducted separately and then through video conference meetings for joint deliberation. We listed all key processes, sub-processes, step and then identified failure mode by scoring based on risk priority numbers. Solutions were then designed to eliminate and mitigate risk.ResultsTransitioning to HHD was found to have the highest risk of failure with 3 main processes and 34 steps. We identified a total of 59 areas with potential failures. The median and mean risk priority number (RPN) scores from failure mode effect analysis were 5 and 38, with the highest RPN related to vascular access at 256. As many failure modes with high RPN scores were related to vascular access, we focussed on FMEA by identifying the risk mitigation strategies and possible solutions in all 9 areas in access-related medical emergencies in a bundled- approach. We discussed, the risk reduction areas of setting up HHD and how to address incidents that occurred and those not preventable.ConclusionsWe developed a safety framework for a de-novo HHD program by performing FMEA in high-risk areas. The involvement of two teams with different clinical experience for HHD allowed us to successfully pre-emptively identify risks and develop solutions.

Project description:OBJECTIVES:Fatigue is common and debilitating among dialysis patients. The aim of this study was to understand the longitudinal trajectory of fatigue and consider sociodemographic, clinical, and psychological factors that are related to variation in fatigue levels over time. DESIGN:A prospective study of fatigue with yearly assessments over 3 years among prevalent in-centre haemodialysis (HD) patients. METHODS:Fatigue severity was measured using the Chalder Fatigue Questionnaire and fatigue-related functional impairment using the Work and Social Adjustment Scale. The trajectories of fatigue outcomes were examined using piecewise growth models, using length of time on dialysis as time. Sociodemographic, clinical, and psychological predictors of fatigue were assessed using linear growth models, using follow-up time. RESULTS:One hundred and seventy-four prevalent HD patients completed baseline measures, 118 at 12 months, 84 at 24 months, and 66 at 36 months. Fatigue severity scores decreased by 0.15 each year. Fatigue-related functional impairment increased by 1.17 each year. In adjusted linear growth models, non-white ethnicity was a significant predictor of lower initial fatigue severity (B = -2.95, 95% CI -5.51 to -0.40) and a greater reduction in fatigue severity of 1.60 each year (95% CI 0.35-2.36). A one-point increase in damage beliefs was associated with a 0.36 increase in fatigue-related functional impairment each year (95% CI -0.61 to -0.01). CONCLUSION:Damage beliefs predicted an increase in fatigue-related functional impairment over time. However, the data strongly suggested that fatigue outcomes vary by length of time on dialysis. Statement of contribution What is already known on this subject? At least 1 in 2 haemodialysis (HD) patients are clinically fatigued. Growing evidence is available on the important role of psychological factors in fatigue across chronic conditions. The contribution of psychological factors, beyond distress, to fatigue in HD has not been examined to date. What does this study add? Ethnicity played a role in the initial level of fatigue severity and over time. Damage beliefs predicted an increase in fatigue-related impairment over time. Data strongly suggested that fatigue outcomes vary by length of time on dialysis.

Project description:ObjectivesMaintenance of vascular access (VA) patency after percutaneous transluminal angioplasty (PTA) is important and remains a challenge despite VA monitoring and surveillance. The aim of this study was to examine factors affecting the post-PTA arteriovenous access (AVA) patency in patients who have been on close VA monitoring and surveillance for access flow.DesignRetrospective cohort study.SettingA single medical centre in Taiwan.ParticipantsRecords of patients who received chronic haemodialysis between 1 January 2017 and 31 December 2018 were retrospectively reviewed. Patients were divided into two groups (without or with PTA intervention on AVA).Primary and secondary outcomePatients were followed until reintervention PTA, termination or abandoned VA or end of study. In addition to routine monitoring, VA flow surveillance was performed every 3 months for detection of VA dysfunction adhering to Kidney Disease Outcomes Quality Initiative guidelines.ResultsA total of 508 patients were selected for study inclusion (with PTA, n=231; without PTA, n=277). At baseline, variables that differed between groups included malignancy and levels of albumin, uric acid, potassium, phosphorous, high-density lipoprotein, total bilirubin and ferritin (all p<0.05). Significant between-group differences were observed for β-adrenergic blocking agents (with PTA, 49.8%; without PTA, 37.5%; p, 0.007) and ADP inhibitors (with PTA, 23.8%; without PTA, 11.2%; p<0.001). Among patients with PTA, those with acute myocardial infarction, high ferritin level or arteriovenous graft (AVG) had a significantly higher risk of reintervention post-PTA (p<0.05). Dipeptidyl peptidase-4 inhibitors, thiazolidinediones, ADP inhibitors, and warfarin use were predictors of post-PTA patency (p<0.05).ConclusionsAVG access type, acute myocardial infarction, and high ferritin levels are risk factors for re-intervention post-PTA. These findings may be useful in the development of prophylactic strategies for monitoring VA function and tailoring surveillance programs for these dialysis patients.

Project description:BackgroundDisorders of consciousness (DoC) are severe neurological conditions in which consciousness is impaired to various degrees. They are caused by injury or malfunction of neural systems regulating arousal and awareness. Over the last decades, major efforts in improving and individualizing diagnostic and prognostic accuracy for patients affected by DoC have been made, mainly focusing on introducing multimodal assessments to complement behavioral examination. The present EU-funded multicentric research project "PerBrain" is aimed at developing an individualized diagnostic hierarchical pathway guided by both behavior and multimodal neurodiagnostics for DoC patients.MethodsIn this project, each enrolled patient undergoes repetitive behavioral, clinical, and neurodiagnostic assessments according to a patient-tailored multi-layer workflow. Multimodal diagnostic acquisitions using state-of-the-art techniques at different stages of the patients' clinical evolution are performed. The techniques applied comprise well-established behavioral scales, innovative neurophysiological techniques (such as quantitative electroencephalography and transcranial magnetic stimulation combined with electroencephalography), structural and resting-state functional magnetic resonance imaging, and measurements of physiological activity (i.e. nasal airflow respiration). In addition, the well-being and treatment decision attitudes of patients' informal caregivers (primarily family members) are investigated. Patient and caregiver assessments are performed at multiple time points within one year after acquired brain injury, starting at the acute disease phase.DiscussionAccurate classification and outcome prediction of DoC are of crucial importance for affected patients as well as their caregivers, as individual rehabilitation strategies and treatment decisions are critically dependent on the latter. The PerBrain project aims at optimizing individual DoC diagnosis and accuracy of outcome prediction by integrating data from the suggested multimodal examination methods into a personalized hierarchical diagnosis and prognosis procedure. Using the parallel tracking of both patients' neurological status and their caregivers' mental situation, well-being, and treatment decision attitudes from the acute to the chronic phase of the disease and across different countries, this project aims at significantly contributing to the current clinical routine of DoC patients and their family members.Trial registrationClinicalTrials.gov, NCT04798456 . Registered 15 March 2021 - Retrospectively registered.

Project description:BackgroundTraditional performance-based measurements of mobility fail to recognize the interaction between the individual and their environment. Life-space (LS) forms a central element in the broader context of mobility and has received growing attention in gerontology. Still, knowledge on LS in the nursing home (NH) remains sparse. The aim of this study was to identify LS trajectories in people with dementia from time of NH admission, and explore characteristics associated with LS over time.MethodsIn total, 583 people with dementia were included at NH admission and assessed biannually for 3 years. LS was assessed using the Nursing Home Life-Space Diameter. Association with individual (age, sex, general medical health, number of medications, pain, physical performance, dementia severity, and neuropsychiatric symptoms) and environmental (staff-to-resident ratio, unit size, and quality of the physical environment) characterises was assessed. We used a growth mixture model to identify LS trajectories and linear mixed model was used to explore characteristics associated with LS over time.ResultsWe identified four groups of residents with distinct LS trajectories, labelled Group 1 (n = 19, 3.5%), Group 2 (n = 390, 72.1%), Group 3 (n = 56, 10.4%), Group 4 (n = 76, 14.0%). Being younger, having good compared to poor general medical health, less severe dementia, more agitation, less apathy, better physical performance and living in a smaller unit were associated with a wider LS throughout the study period.ConclusionFrom NH admission most NH residents' LS trajectory remained stable (Group 2), and their daily lives unfolded within their unit. Better physical performance and less apathy emerged as potentially modifiable characteristics associated with wider LS over time. Future studies are encouraged to determine whether LS trajectories in NH residents are modifiable, and we suggest that future research further explore the impact of environmental characteristics.

Project description:Aim Although cardiac rehabilitation improves physical fitness after a cardiac event, many eligible patients do not participate in cardiac rehabilitation and the beneficial effects of cardiac rehabilitation are often not maintained over time. Home-based training with telemonitoring guidance could improve participation rates and enhance long-term effectiveness. Methods and results We randomised 90 low-to-moderate cardiac risk patients entering cardiac rehabilitation to three months of either home-based training with telemonitoring guidance or centre-based training. Although training adherence was similar between groups, satisfaction was higher in the home-based group ( p?=?0.02). Physical fitness improved at discharge ( p?<?0.01) and at one-year follow-up ( p?<?0.01) in both groups, without differences between groups (home-based p?=?0.31 and centre-based p?=?0.87). Physical activity levels did not change during the one-year study period (centre-based p?=?0.38, home-based p?=?0.80). Healthcare costs were statistically non-significantly lower in the home-based group (€437 per patient, 95% confidence interval -562 to 1436, p?=?0.39). From a societal perspective, a statistically non-significant difference of €3160 per patient in favour of the home-based group was found (95% confidence interval -460 to 6780, p?=?0.09) and the probability that it was more cost-effective varied between 97% and 75% (willingness-to-pay of €0 and €100,000 per quality-adjusted life-years, respectively). Conclusion We found no differences between home-based training with telemonitoring guidance and centre-based training on physical fitness, physical activity level or health-related quality of life. However, home-based training was associated with a higher patient satisfaction and appears to be more cost-effective than centre-based training. We conclude that home-based training with telemonitoring guidance can be used as an alternative to centre-based training for low-to-moderate cardiac risk patients entering cardiac rehabilitation.

Project description:Background: More than a decade after the National Institute for Health and Clinical Excellence recommendation of home haemodialysis (home HD) for 10-15% of those needing renal replacement therapy, the uptake across different regions in the UK remains uneven. Methods: This survey is part of the Barriers to Successful Implementation of Care in Home Haemodialysis (BASIC-HHD) study, an observational study of patient and organizational factor barriers and enablers of home HD uptake, in the UK. The study centres had variable prevalence of home HD by design [low: <3% (2), medium: 5-8% (2) and high: >8% (1)]. This survey was administered electronically in 2013, and had 20 questions pertaining to home HD beliefs and practices. A total of 104 members of staff across five study centres were approached to complete the survey. Results: The response rate was 46%, mostly from experienced HD practitioners. Most believed in the benefits of home HD therapy. Across all centres, respondents believed that preconceptions about patients' and carers' ability to cope with home HD (35% to a great or very great extent) and staff knowledge and bias influenced offer of home HD therapy (45%). Also, compared with respondents from high prevalence (HP) centre, those from low prevalence (LP) centres felt that display and presentation of dialysis information lacked clarity and uniformity (44% versus 18%), and that a better set-up for training patients for self-care HD was required (72.8% versus 33.3%). A greater proportion of respondents from the HP centre expressed concerns over caregiver support and respite care for patients on home HD (63.7% versus 33.3%). Conclusions: Survey results indicate that across all centres in the study, there is an appetite for growing home HD. There are some differences in attitudes and practice between LP and HP centres. There are other domains where all centres have expressed concern and addressing these will be influential in navigating change from the current course.

Dataset Information

Comparison of physical activity and quality of life in home haemodialysis (HHD) patients versus conventional in-centre haemodialysis (ICHD) patients: the observational, longitudinal, prospective, international, multicentric SeCoIA study protocol.

Publications

Comparison of physical activity and quality of life in home haemodialysis (HHD) patients versus conventional in-centre haemodialysis (ICHD) patients: the observational, longitudinal, prospective, international, multicentric SeCoIA study protocol.

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