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

January 10, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Maurice, France, 94410
        • CTIRC - Hôpitaux Saint Maurice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with renal failure under peritoneal dialysis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tele-consulting
One visit out of two takes place with teleconsulting and the other is a face-to-face consultation
Device: Teleconsulting
Other Names:
  • Telemedicine
No tele-consulting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 2 years after enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence Regionale de Sante d'Ile de France

Investigators

  • Principal Investigator: Isabelle Durand-Zaleski, MD, PhD, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Stéphane Roueff, MD, Pôle CTIRC. Hôpitaux Saint Maurice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLM-HSMDP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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