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

March 9, 2020 updated by: Physidia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche-sur-Yon, France, 85000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Daily hemodialysis patients

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.
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

Other Names:
  • Quality of life and restless leg syndrome questionnaires
ACTIVE_COMPARATOR: Conventional hemodialysis patients

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.
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

Other Names:
  • Quality of life and restless leg syndrome questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
Time Frame: 3 months
The main criteria is the total average number of steps taken per day
3 months
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
Time Frame: 6 months
The main criteria is the total average number of steps taken per day
6 months
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
Time Frame: 9 months
The main criteria is the total average number of steps taken per day
9 months
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
Time Frame: 12 months
The main criteria is the total average number of steps taken per day
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the blood pressure during the study period
Time Frame: 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
At inclusion and during visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Evolution of the frequency of hospitalizations during the study period
Time Frame: During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
number of hospitalizations period
During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Change in quality of life of the patients measured through questionnaire during the study period
Time Frame: At inclusion and during visit at month 3, 6, 9 and 12
Questionnaire KDQOL-SF version 1.2 (auto questionnaire)
At inclusion and during visit at month 3, 6, 9 and 12
Change in quality of the sleep of the patients through questionnaire during the study period
Time Frame: At inclusion and during visit at month 3, 6, 9 and 12
Pittsburgh Sleep Quality Index PSQI version 1.0 (auto questionnaire)
At inclusion and during visit at month 3, 6, 9 and 12
Change of the percentage of patients with restless leg syndrome (RLS) during the study period
Time Frame: At inclusion and during visit at month 3, 6, 9 and 12
International scale of Restless leg syndrome severity IRLS V1.0 (auto questionnaire)
At inclusion and during visit at month 3, 6, 9 and 12
Change of drug intake during the study period (posology of drugs linked with ESRD)
Time Frame: 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)
During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physidia

Investigators

  • Principal Investigator: Natalia Target, MD, Centre Hospitalier La Roche sur Yon - France
  • Study Chair: Cécile Courivaud, MD, CHRU Jean Minjoz, Besançon, France
  • Study Chair: Pierre Antoine Michel, MD, Hôpital Tenon APHP, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 27, 2018

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (ACTUAL)

November 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018A00838-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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