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

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Delivery of a connected pedometer / accelerometer
Sponsored by
Physidia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Home hemodialysis, Daily hemodialysis, Frequent hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre HospitalierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daily hemodialysis patients

Conventional hemodialysis patients

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Evolution of the blood pressure during the study period
Systolic and diastolic blood pressure measurement
Evolution of the frequency of hospitalizations during the study period
number of hospitalizations period
Change in quality of life of the patients measured through questionnaire during the study period
Questionnaire KDQOL-SF version 1.2 (auto questionnaire)
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)
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)
Change of drug intake during the study period (posology of drugs linked with ESRD)
Evolution of drugs posology (drug linked with ESRD)

Full Information

First Posted
October 22, 2018
Last Updated
March 9, 2020
Sponsor
Physidia
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1. Study Identification

Unique Protocol Identification Number
NCT03737578
Brief Title
Comparison of Daily Home Hemodialysis (HD) With Conventional in Center HD in Terms of Patients Quality of Life and Clinical Outcomes
Acronym
SeCoIA
Official Title
Efficacy of Daily Hemodialysis Compared With in Center Hemodialysis 3 Times Per Week
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physidia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: To describe the characteristics of daily hemodialysis patients; To describe the prescription procedures of the home daily HD; To compare the evolution of the blood pressure between the 2 modalities of hemodialysis; To compare the frequency of hospitalizations, duration and hospitalization reasons between the 2 hemodialysis modalities; To compare the quality of life of the patients between the 2 modalities ; To evaluate the quality of the sleep of the patients between the 2 modalities ; Compare the percentage of patients with restless leg syndrome (RLS) and the severity of RLS between the two modalities; Compare the evolution of drug intake between the two modalities; Evaluate the number of abandoning subjects and causes of discontinuation of HQD;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Home hemodialysis, Daily hemodialysis, Frequent hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
this is an interventional, pragmatic study with minimal risks, exposed / unexposed, prospective, longitudinal, multicentric and national conducted in metropolitan France
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Daily hemodialysis patients
Arm Type
Experimental
Arm 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.
Arm Title
Conventional hemodialysis patients
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Delivery of a connected pedometer / accelerometer
Other Intervention Name(s)
Quality of life and restless leg syndrome questionnaires
Intervention Description
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
Primary Outcome Measure Information:
Title
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
Description
The main criteria is the total average number of steps taken per day
Time Frame
3 months
Title
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
Description
The main criteria is the total average number of steps taken per day
Time Frame
6 months
Title
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
Description
The main criteria is the total average number of steps taken per day
Time Frame
9 months
Title
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
Description
The main criteria is the total average number of steps taken per day
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evolution of the blood pressure during the study period
Description
Systolic and diastolic blood pressure measurement
Time Frame
At inclusion and during visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Title
Evolution of the frequency of hospitalizations during the study period
Description
number of hospitalizations period
Time Frame
During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Title
Change in quality of life of the patients measured through questionnaire during the study period
Description
Questionnaire KDQOL-SF version 1.2 (auto questionnaire)
Time Frame
At inclusion and during visit at month 3, 6, 9 and 12
Title
Change in quality of the sleep of the patients through questionnaire during the study period
Description
Pittsburgh Sleep Quality Index PSQI version 1.0 (auto questionnaire)
Time Frame
At inclusion and during visit at month 3, 6, 9 and 12
Title
Change of the percentage of patients with restless leg syndrome (RLS) during the study period
Description
International scale of Restless leg syndrome severity IRLS V1.0 (auto questionnaire)
Time Frame
At inclusion and during visit at month 3, 6, 9 and 12
Title
Change of drug intake during the study period (posology of drugs linked with ESRD)
Description
Evolution of drugs posology (drug linked with ESRD)
Time Frame
During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 years or over Patient who dated and signed the consent form Patient (s) affiliated to a Social Security scheme Interventional arm: patient who begins or will begin daily hemodialysis training (5, 6 or 7 times per week) at home. 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: Patient with needs any help to walk (wheelchair, crutch, walker, cane ...) Patient with active neoplasia; Patient with predicted life expectancy of less than one year; Patient with significant reading or writing difficulties; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Thomas, PhD
Phone
+33 (0)6 74 28 71 99
Email
michel.thomas@physidia.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bernadette Darne, MD
Phone
+33 (0) 1 39 62 15 27
Email
bernadette.darne@monitoring-force.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Target, MD
Organizational Affiliation
Centre Hospitalier La Roche sur Yon - France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cécile Courivaud, MD
Organizational Affiliation
CHRU Jean Minjoz, Besançon, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pierre Antoine Michel, MD
Organizational Affiliation
Hôpital Tenon APHP, Paris, France
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Target, MD
Phone
+33 (0) 2 51 44 61 65
Email
natalia.target@chd-vendee.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
33225917
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.
Results Reference
derived

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

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