NCT03737578

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

October 22, 2018

Last Update Submit

March 9, 2020

Conditions

End Stage Renal Disease

Keywords

Home hemodialysisDaily hemodialysisFrequent hemodialysis

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Delivery of a connected pedometer / accelerometer

Interventions

Delivery of a connected pedometer / accelerometerOTHER

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

Also known as: Quality of life and restless leg syndrome questionnaires
Conventional hemodialysis patientsDaily hemodialysis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier

La Roche-sur-Yon, 85000, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33225917DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Natalia Target, MD

    Centre Hospitalier La Roche sur Yon - France

    PRINCIPAL INVESTIGATOR

  • Cécile Courivaud, MD

    CHRU Jean Minjoz, Besançon, France

    STUDY CHAIR

  • Pierre Antoine Michel, MD

    Hôpital Tenon APHP, Paris, France

    STUDY CHAIR

Central Study Contacts

Michel Thomas, PhD

CONTACT

+33 (0)6 74 28 71 99michel.thomas@physidia.fr

Bernadette Darne, MD

CONTACT

+33 (0) 1 39 62 15 27bernadette.darne@monitoring-force.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: this is an interventional, pragmatic study with minimal risks, exposed / unexposed, prospective, longitudinal, multicentric and national conducted in metropolitan France
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

November 9, 2018

Study Start

June 27, 2018

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

FR(1)