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

End Stage Renal Disease Clinical Trial

— SeCoIA  

Official title:

Efficacy of Daily Hemodialysis Compared With in Center Hemodialysis 3 Times Per Week

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03737578
• Other study ID #: 2018A00838-47
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2018
• Est. completion date: June 2021

Study information

• Verified date: March 2020
• Source: Physidia
• Contact: Michel Thomas, PhD
• Phone: +33 (0)6 74 28 71 99
• Email: michel.thomas[@]physidia.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Delivery 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

Locations

Country	Name	City	State
France	Centre Hospitalier	La Roche-sur-Yon

Sponsors (1)

Lead Sponsor	Collaborator
Physidia

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Evolution of the frequency of hospitalizations during the study period	number of hospitalizations period	During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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