End Stage Renal Disease
Conditions
Keywords
Home hemodialysis, Daily hemodialysis, Frequent hemodialysis
Brief summary
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
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: 1. To describe the characteristics of daily hemodialysis patients; 2. To describe the prescription procedures of the home daily HD; 3. To compare the evolution of the blood pressure between the 2 modalities of hemodialysis; 4. To compare the frequency of hospitalizations, duration and hospitalization reasons between the 2 hemodialysis modalities; 5. To compare the quality of life of the patients between the 2 modalities ; 6. To evaluate the quality of the sleep of the patients between the 2 modalities ; 7. Compare the percentage of patients with restless leg syndrome (RLS) and the severity of RLS between the two modalities; 8. Compare the evolution of drug intake between the two modalities; 9. Evaluate the number of abandoning subjects and causes of discontinuation of HQD;
Interventions
OTHERDelivery of a connected pedometer / accelerometer
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
Sponsors
Physidia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
this is an interventional, pragmatic study with minimal risks, exposed / unexposed, prospective, longitudinal, multicentric and national conducted in metropolitan France
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 18 years or over 2. Patient who dated and signed the consent form 3. Patient (s) affiliated to a Social Security scheme 4. Interventional arm: patient who begins or will begin daily hemodialysis training (5, 6 or 7 times per week) at home. 5. 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
1. Patient with needs any help to walk (wheelchair, crutch, walker, cane ...) 2. Patient with active neoplasia; 3. Patient with predicted life expectancy of less than one year; 4. Patient with significant reading or writing difficulties; 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer) | 3 months | The main criteria is the total average number of steps taken per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the frequency of hospitalizations during the study period | During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | number of hospitalizations period |
| Change in quality of life of the patients measured through questionnaire during the study period | At inclusion and during visit at month 3, 6, 9 and 12 | Questionnaire KDQOL-SF version 1.2 (auto questionnaire) |
| Evolution of the blood pressure during the study period | At inclusion and during visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | Systolic and diastolic blood pressure measurement |
| Change of the percentage of patients with restless leg syndrome (RLS) during the study period | At inclusion and during visit at month 3, 6, 9 and 12 | International scale of Restless leg syndrome severity IRLS V1.0 (auto questionnaire) |
| Change of drug intake during the study period (posology of drugs linked with ESRD) | During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | Evolution of drugs posology (drug linked with ESRD) |
| Change in quality of the sleep of the patients through questionnaire during the study period | At inclusion and during visit at month 3, 6, 9 and 12 | Pittsburgh Sleep Quality Index PSQI version 1.0 (auto questionnaire) |
Countries
France
Contacts
Primary ContactMichel Thomas, PhD
Backup ContactBernadette Darne, MD
Outcome results
None listed