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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily hemodialysis patients | Experimental | 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. |
|
| Conventional hemodialysis patients | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delivery of a connected pedometer / accelerometer | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel Thomas, PhD | Contact | +33 (0)6 74 28 71 99 | michel.thomas@physidia.fr | |
| Bernadette Darne, MD | Contact | +33 (0) 1 39 62 15 27 | bernadette.darne@monitoring-force.fr |
| Name | Affiliation | Role |
|---|---|---|
| Natalia Target, MD | Centre Hospitalier La Roche sur Yon - France | Principal Investigator |
| Cécile Courivaud, MD | CHRU Jean Minjoz, Besançon, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier | Recruiting | La Roche-sur-Yon | 85000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33225917 | Derived | Target N, Courivaud C, Michel PA, Daoud S, Thomas M. 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. BMC Nephrol. 2020 Nov 23;21(1):500. doi: 10.1186/s12882-020-02127-7. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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this is an interventional, pragmatic study with minimal risks, exposed / unexposed, prospective, longitudinal, multicentric and national conducted in metropolitan France
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|
|
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 |
| Pierre Antoine Michel, MD |
| Hôpital Tenon APHP, Paris, France |
| Study Chair |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004778 |
| Environment and Public Health |