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

Physidia

Status: Unknown

Conditions: End Stage Renal Disease

Treatments: Other: Delivery of a connected pedometer / accelerometer

Study type: Interventional

Funder types: Industry

Identifiers

NCT03737578

2018A00838-47

Details and patient eligibility

About

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.

Full 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;

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Daily hemodialysis patients

Experimental group

Description:

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.

Treatment:

Other: Delivery of a connected pedometer / accelerometer

Conventional hemodialysis patients

Active Comparator group

Description:

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.

Treatment:

Other: Delivery of a connected pedometer / accelerometer