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

NCT03019159 | Withdrawn

• 1 other identifier: TLM-HSMDP
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Renal Failure; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

Tele-consulting

One visit out of two takes place with teleconsulting and the other is a face-to-face consultation

Device: Teleconsulting

No tele-consulting

Interventions

Teleconsulting DEVICE

Also known as: Telemedicine

Tele-consulting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with renal failure under peritoneal dialysis

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Agence Regionale de Sante d'Ile de France: collaborator

Study Sites (1)

CTIRC - Hôpitaux Saint Maurice

Saint-Maurice, 94410, France

Location

Related 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. doi: 10.1258/135763307781644906.

  PMID: 17785025 BACKGROUND

• 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.

  PMID: 22617736 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane Roueff, MD

  Pôle CTIRC. Hôpitaux Saint Maurice

  PRINCIPAL INVESTIGATOR

• Isabelle Durand-Zaleski, MD, PhD

  DRCD URC Eco. Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2014-06

Locations

FR (1)