End Stage Renal DiseaseSeCoIANCT03737578
Comparison of Daily Home Hemodialysis (HD) With Conventional in Center HD in Terms of Patients Quality of Life and Clinical Outcomes
A study testing Delivery of a connected pedometer / accelerometer in people with End Stage Renal Disease, run by Physidia at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Delivery of a connected pedometer / accelerometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2018to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier
La Roche-sur-Yon, 85000
Natalia Target, MD, +33 (0) 2 51 44 61 65, natalia.target@chd-vendee.fr
About this study
Official title: 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.
Read the 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;
- Conditions
- End Stage Renal Disease
- Being tested
- Delivery of a connected pedometer / accelerometer
- Keywords
- Home hemodialysis, Daily hemodialysis, Frequent hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of a connected pedometer / accelerometerOther
Also called Quality of life and restless leg syndrome questionnaires
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
| Study group | Role | What they receive |
|---|---|---|
| Daily hemodialysis patients | Experimental | 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. Receives: Other: Delivery of a connected pedometer / accelerometer |
| Conventional hemodialysis patients | Active comparator | 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. Receives: Other: Delivery of a connected pedometer / accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
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
Measured: 6 months
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
Measured: 9 months
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
Measured: 12 months
Secondary outcomes (6)
Evolution of the blood pressure during the study period
Systolic and diastolic blood pressure measurement
Measured: 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
number of hospitalizations period
Measured: 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
Questionnaire KDQOL-SF version 1.2 (auto questionnaire)
Measured: 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
Pittsburgh Sleep Quality Index PSQI version 1.0 (auto questionnaire)
Measured: 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
International scale of Restless leg syndrome severity IRLS V1.0 (auto questionnaire)
Measured: 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)
Evolution of drugs posology (drug linked with ESRD)
Measured: During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start27 Jun 2018
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Physidia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Target, MD, Principal investigator, Centre Hospitalier La Roche sur Yon - FranceCécile Courivaud, MD, Study chair, CHRU Jean Minjoz, Besançon, FrancePierre Antoine Michel, MD, Study chair, Hôpital Tenon APHP, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737578
- Sponsor's protocol ID
- 2018A00838-47
- Acronym
- SeCoIA
- Status last verified
- Mar 2020
- First submitted
- 22 Oct 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Target NG, Michel PA, Courivaud C, Thomas M, Le Floc'h F, Canaud B. Physical Activity in Short Daily Home Dialysis versus to In-Center Hemodialysis: Results from the Self-convecTive Evaluation of Short Daily Home Dialysis on Physical Activity Study. Kidney360. 2026 Sep 1;7(9):2075-2086. doi: 10.34067/KID.0000001246. Epub 2026 Jun 18.
PubMed 42308431Target 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.
PubMed 33225917
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Daily Hemodialysis Compared With in Center Hemodialysis 3 Times Per Week
- ClinicalTrials.gov ID
- NCT03737578
- Acronym / sponsor ID
- SeCoIA / 2018A00838-47
- Conditions
- End Stage Renal Disease
- Keywords
- Home hemodialysis, Daily hemodialysis, Frequent hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- PhysidiaIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- this is an interventional, pragmatic study with minimal risks, exposed / unexposed, prospective, longitudinal, multicentric and national conducted in metropolitan France
| Arm | Type | Receives |
|---|---|---|
| Daily hemodialysis patients | Experimental | Other: Delivery of a connected pedometer / accelerometerDescription: 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 | Active comparator | Other: Delivery of a connected pedometer / accelerometerDescription: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivery of a connected pedometer / accelerometerAlso: Quality of life and restless leg syndrome questionnairesDelivery 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 | Conventional hemodialysis patients, Daily hemodialysis patients |
Primary outcome
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
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
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 42308431Target NG, Michel PA, Courivaud C, Thomas M, Le Floc'h F, Canaud B. Physical Activity in Short Daily Home Dialysis versus to In-Center Hemodialysis: Results from the Self-convecTive Evaluation of Short Daily Home Dialysis on Physical Activity Study. Kidney360. 2026 Sep 1;7(9):2075-2086. doi: 10.34067/KID.0000001246. Epub 2026 Jun 18.
- Derived from this study: PubMed 33225917Target 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Target, MD principal investigator
Centre Hospitalier La Roche sur Yon - France
Cécile Courivaud, MD study chair
CHRU Jean Minjoz, Besançon, France
Pierre Antoine Michel, MD study chair
Hôpital Tenon APHP, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of a connected pedometer / accelerometer in people with End Stage Renal Disease, run by Physidia at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Thomas, PhD (+33 (0)6 74 28 71 99, michel.thomas@physidia.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737578, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.