Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis

Withdrawn

• Conditions: Peritoneal Dialysis; Chronic Renal Failure
• Interventions: Device: Teleconsulting

• Registration Number: NCT03019159
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study Start: 2014-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient under peritoneal dialysis for more than three month
• Patient thought to be able to perform peritoneal dialysis alone or with the help of health care professionnals
• Patients or health care professionnals thought to be able to use telemedicine

Exclusion Criteria

• No DSL Network
• No GSM Network
• Patients who can not express their opposition to the participation to this study because of limited mental abilities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tele-consulting	Teleconsulting	One visit out of two takes place with teleconsulting and the other is a face-to-face consultation

Primary Outcome Measures

Name	Time	Method
Severe adverse events	Within 2 years after enrollment	Death, Peritonitis, acute pulmonary edema, symptomatic hyperkalemia or with EKG signs, severe and resistant hypertension, with uremia \> 40 mmol/L

Secondary Outcome Measures

Name	Time	Method
Number of hospitalisations	Within 2 years after enrollment
Number of consultations	Within 2 years after enrollment
Number of sanitary transportation	Within 2 years after enrollment
Mean length of hospital stay	Within 2 years after enrollment
Global costs	6 months after the first patient enrollment
Patients satisfaction	1 year after enrollment
Satisfaction of the professionnals	6 months after enrollment of the first patient

Trial Locations

Locations (1)

CTIRC - Hôpitaux Saint Maurice; 🇫🇷 Saint Maurice, France