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

Chronic Renal Failure Clinical Trial

— HSMDP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03019159
• Other study ID #: TLM-HSMDP
• Status: Withdrawn
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 10, 2017
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Peritoneal Dialysis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Teleconsulting

Locations

Country	Name	City	State
France	CTIRC - Hôpitaux Saint Maurice	Saint Maurice

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Agence Regionale de Sante d'Ile de France

Country where clinical trial is conducted

France, 

References & Publications (2)

Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. — View Citation

Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe adverse events	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	Yes
Secondary	Number of hospitalisations		Within 2 years after enrollment	Yes
Secondary	Number of consultations		Within 2 years after enrollment	No
Secondary	Number of sanitary transportation		Within 2 years after enrollment	No
Secondary	Mean length of hospital stay		Within 2 years after enrollment	No
Secondary	Global costs		6 months after the first patient enrollment	No
Secondary	Patients satisfaction		1 year after enrollment	No
Secondary	Satisfaction of the professionnals		6 months after enrollment of the first patient	No

External Links

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