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

Not Applicable

• Conditions: End Stage Renal Disease
• Interventions: Other: Delivery of a connected pedometer / accelerometer

• Registration Number: NCT03737578
• Lead Sponsor: Physidia

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;

Study Timeline

• Study Start: 2018-06-27
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily hemodialysis patients	Delivery of a connected pedometer / accelerometer	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	Delivery of a connected pedometer / accelerometer	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.

Primary Outcome Measures

Name	Time	Method
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)	12 months	The main criteria is the total average number of steps taken per day

Secondary Outcome Measures

Name	Time	Method
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 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)
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)
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 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)
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)

Trial Locations

Locations (1)

Centre Hospitalier; 🇫🇷 La Roche-sur-Yon, France