Clinical trial NCT03737578: Comparison of Daily Home Hemodialysis (HD) With Conventional in Center HD in Terms of Patients Quality of Life and Clinical Outcomes
Official title: Efficacy of Daily Hemodialysis Compared With in Center Hemodialysis 3 Times Per Week
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Home hemodialysis
Daily hemodialysis
Frequent hemodialysis
Lead sponsor: Physidia
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this is an interventional, pragmatic study with minimal risks, exposed / unexposed, prospective, longitudinal, multicentric and national conducted in metropolitan France
Primary purpose: TREATMENT

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;

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
timeFrame: 3 months
measure: Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
timeFrame: 6 months
measure: Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
timeFrame: 9 months
measure: Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
timeFrame: 12 months
Secondary outcomes:
measure: Evolution of the blood pressure during the study period
timeFrame: At inclusion and during visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
measure: Evolution of the frequency of hospitalizations during the study period
timeFrame: During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
measure: Change in quality of life of the patients measured through questionnaire during the study period
timeFrame: At inclusion and during visit at month 3, 6, 9 and 12
measure: Change in quality of the sleep of the patients through questionnaire during the study period
timeFrame: At inclusion and during visit at month 3, 6, 9 and 12
measure: Change of the percentage of patients with restless leg syndrome (RLS) during the study period
timeFrame: At inclusion and during visit at month 3, 6, 9 and 12
measure: Change of drug intake during the study period (posology of drugs linked with ESRD)
timeFrame: During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier
Study officials:
affiliation: Centre Hospitalier La Roche sur Yon - France
name: Natalia Target, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Jean Minjoz, Besançon, France
name: Cécile Courivaud, MD
role: STUDY_CHAIR
affiliation: Hôpital Tenon APHP, Paris, France
name: Pierre Antoine Michel, MD
role: STUDY_CHAIR
References:
citation: 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.