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Clinical Trials/NCT03019159
NCT03019159
Withdrawn
N/A

Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis

Assistance Publique - Hôpitaux de Paris1 site in 1 countrySeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Renal Failure
Sponsor
Assistance Publique - Hôpitaux de Paris
Locations
1
Primary Endpoint
Severe adverse events
Status
Withdrawn
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
September 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Severe adverse events

Time Frame: 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 Outcomes

  • Number of sanitary transportation(Within 2 years after enrollment)
  • Number of hospitalisations(Within 2 years after enrollment)
  • Number of consultations(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)

Study Sites (1)

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