Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

Renal Transplantation Clinical Trial

— APT'x  

Official title:

Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03750331
• Other study ID #: 1708232
• Secondary ID: 2018-A00677-48
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 738
• Est. completion date: December 2025
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients transplanted for at least 3 months

• Stable renal graft function

Exclusion Criteria:

• No home internet access

• Major disability

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Other:
• Ap'Telecare
an internet application on a computer, tablet or smartphone
• traditional schedule
a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule

Locations

Country	Name	City	State
France	Clermont-Ferrand, CHU Site Gabriel-Montpied	Clermont-Ferrand
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients experiencing at least one episode of graft dysfunction	graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value)	2 years
Secondary	Failure of immunosuppressive treatment	Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic	2 years
Secondary	number of patients who needed to return to dialysis		2 years
Secondary	number of patients with acute or chronic transplant rejection		2 years
Secondary	Post-transplant complication		2 years
Secondary	Death		2 years
Secondary	Quality of life assessed	EuroQol group - 5 Dimensions ( EQ-5D) scale	2 years
Secondary	Level of anxiety and depression	Hospital Anxiety and Depression (HAD) scale	2 years
Secondary	Incremental cost-effectiveness evaluation criteria	Cost per QALY earned (QALYs estimated from the EuroQol group - 5 Dimensions ( EQ-5D) quality of life scale).	2 years
Secondary	Evaluation criteria for the Budget Impact Analysis	Average cost saved per 100 patients treated in the "Ap'Telecare group" compared to the "traditional follow-up".	2 years