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

Last updated: March 9, 2020
Sponsor: Physidia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03737578
2018A00838-47
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, 6or 7 times per week) at home.

  5. Comparator arm: prevalent or incident patient treated by conventional hemodialysis (3times per week) and fitting with the matching criteria of an interventional patientincluded in the center

Exclusion

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. Patientwith history of mental instability, major cognitive impairment in the previous 5years, or major psychiatric condition not adequately controlled or stable underpharmacological treatment

Study Design

Total Participants: 160
Study Start date:
June 27, 2018
Estimated Completion Date:
June 30, 2021

Study 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;

Connect with a study center

  • Centre Hospitalier

    La Roche-sur-Yon, 85000
    France

    Active - Recruiting

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