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

NCT ID: NCT03737578

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-27
• Study Completion Date: 2021-06-30

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:

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;

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Delivery of a connected pedometer / accelerometer

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Delivery of a connected pedometer / accelerometer

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Quality of life and restless leg syndrome questionnaires

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Physidia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Target, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier La Roche sur Yon - France

Cécile Courivaud, MD

Role: STUDY_CHAIR

CHRU Jean Minjoz, Besançon, France

Pierre Antoine Michel, MD

Role: STUDY_CHAIR

Hôpital Tenon APHP, Paris, France

Locations

Centre Hospitalier

La Roche-sur-Yon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Michel Thomas, PhD

Role: CONTACT

michel.thomas@physidia.fr

+33 (0)6 74 28 71 99

Bernadette Darne, MD

Role: CONTACT

bernadette.darne@monitoring-force.fr

+33 (0) 1 39 62 15 27

Facility Contacts

Natalia Target, MD

Role: primary

natalia.target@chd-vendee.fr

+33 (0) 2 51 44 61 65

References

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.

Reference Type: DERIVED

PMID: 33225917 (View on PubMed)

Other Identifiers

2018A00838-47

Identifier Type: -

Identifier Source: org_study_id