Comparison of Daily Home Hemodialysis (HD) With Conventional in Center HD in Terms of Patients Quality of Life and Clinical Outcomes

Study Overview
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Brief Summary
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The objective of this study is to describe the characteristics of patients on daily home hemodialysis and to confirm in real practice in France the effectiveness shown in studies, mainly American, both in terms of clinical outcomes and quality of life. Due to the few studies available in this population, the focus will be particularly on physical activity.

Detailed Description
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Primary objective : The main objective of this study is to evaluate the physical activity in the daily life of patients in daily hemodialysis in comparison with patients treated 3 times a week (conventional hemodialysis) others objectives are also: To describe the characteristics of daily hemodialysis patients; To describe the prescription procedures of the home daily HD; To compare the evolution of the blood pressure between the 2 modalities of hemodialysis; To compare the frequency of hospitalizations, duration and hospitalization reasons between the 2 hemodialysis modalities; To compare the quality of life of the patients between the 2 modalities ; To evaluate the quality of the sleep of the patients between the 2 modalities ; Compare the percentage of patients with restless leg syndrome (RLS) and the severity of RLS between the two modalities; Compare the evolution of drug intake between the two modalities; Evaluate the number of abandoning subjects and causes of discontinuation of HQD;

Official Title
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Efficacy of Daily Hemodialysis Compared With in Center Hemodialysis 3 Times Per Week

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: Delivery of a connected pedometer / accelerometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 years or over Patient who dated and signed the consent form Patient (s) affiliated to a Social Security scheme Interventional arm: patient who begins or will begin daily hemodialysis training (5, 6 or 7 times per week) at home. Comparator arm: prevalent or incident patient treated by conventional hemodialysis (3 times per week) and fitting with the matching criteria of an interventional patient included in the center Exclusion Criteria: Patient with needs any help to walk (wheelchair, crutch, walker, cane ...) Patient with active neoplasia; Patient with predicted life expectancy of less than one year; Patient with significant reading or writing difficulties; Patient participating in a clinical trial or other interventional study; 6. Patient with history of mental instability, major cognitive impairment in the previous 5 years, or major psychiatric condition not adequately controlled or stable under pharmacological treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: this is an interventional, pragmatic study with minimal risks, exposed / unexposed, prospective, longitudinal, multicentric and national conducted in metropolitan France
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily hemodialysis patients<br>Description: End stage renal disease patients starting daily hemodialysis treatment. Interventions: Delivery of a connected pedometer / accelerometer and Quality Of Life and Restless Leg Syndrome questionnaires. | Other: Delivery of a connected pedometer / accelerometer<br>* Delivery of a connected pedometer / accelerometer that the patient will be asked to wear at least 7 consecutive days / month. Quality of life and leg restless syndrome questionnaires (auto questionnaire) completed by the patients every 3 months<br>* Other names: Quality of life and restless leg syndrome questionnaires;|
| Active Comparator: Conventional hemodialysis patients<br>Description: End stage renal disease patients currently treated by conventional hemodialysis or starting conventional hemodialysis treatment. Interventions: Delivery of a connected pedometer / accelerometer and Quality Of Life and Restless Leg Syndrome questionnaires. | Other: Delivery of a connected pedometer / accelerometer<br>* Delivery of a connected pedometer / accelerometer that the patient will be asked to wear at least 7 consecutive days / month. Quality of life and leg restless syndrome questionnaires (auto questionnaire) completed by the patients every 3 months<br>* Other names: Quality of life and restless leg syndrome questionnaires;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer) | The main criteria is the total average number of steps taken per day | 3 months | 
| Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer) | The main criteria is the total average number of steps taken per day | 6 months | 
| Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer) | The main criteria is the total average number of steps taken per day | 9 months | 
| Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer) | The main criteria is the total average number of steps taken per day | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the blood pressure during the study period | Systolic and diastolic blood pressure measurement | At inclusion and during visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | 
| Evolution of the frequency of hospitalizations during the study period | number of hospitalizations period | During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | 
| Change in quality of life of the patients measured through questionnaire during the study period | Questionnaire KDQOL-SF version 1.2 (auto questionnaire) | At inclusion and during visit at month 3, 6, 9 and 12 | 
| Change in quality of the sleep of the patients through questionnaire during the study period | Pittsburgh Sleep Quality Index PSQI version 1.0 (auto questionnaire) | At inclusion and during visit at month 3, 6, 9 and 12 | 
| Change of the percentage of patients with restless leg syndrome (RLS) during the study period | International scale of Restless leg syndrome severity IRLS V1.0 (auto questionnaire) | At inclusion and during visit at month 3, 6, 9 and 12 | 
| Change of drug intake during the study period (posology of drugs linked with ESRD) | Evolution of drugs posology (drug linked with ESRD) | During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home hemodialysis, Daily hemodialysis, Frequent hemodialysis