NCT03737578

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Physidia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-27
• Primary completion: 2020-12-01
• Completion: 2021-06-01
• First posted: 2018-11-09
• Last updated: 2020-03-10

Locations

1 site across 1 country: France