Chronic Renal Failure Clinical Trial
— HSMDPOfficial title:
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
Status | Withdrawn |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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | CTIRC - Hôpitaux Saint Maurice | Saint Maurice |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Agence Regionale de Sante d'Ile de France |
France,
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
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 |
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