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

Not Applicable

Active, not recruiting

• Conditions: Renal Transplantation
• Interventions: Other: traditional schedule; Other: Ap'Telecare

• Registration Number: NCT03750331
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-23
• Study Start: 2018-12-17
• Primary Completion: 2023-10-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 738

Inclusion Criteria

• Patients transplanted for at least 3 months
• Stable renal graft function

Exclusion Criteria

• No home internet access
• Major disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional patient follow-up	traditional schedule	a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter)
medically-tailored follow-up with Ap'Telecare	Ap'Telecare	a group of patients assisted by Ap'Telecare and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).

Primary Outcome Measures

Name	Time	Method
Patients experiencing at least one episode of graft dysfunction	2 years	graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value)

Secondary Outcome Measures

Name	Time	Method
Post-transplant complication	2 years
Evaluation criteria for the Budget Impact Analysis	2 years	Average cost saved per 100 patients treated in the "Ap'Telecare group" compared to the "traditional follow-up".
Quality of life assessed	2 years	EuroQol group - 5 Dimensions ( EQ-5D) scale
Level of anxiety and depression	2 years	Hospital Anxiety and Depression (HAD) scale
Death	2 years
Failure of immunosuppressive treatment	2 years	Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic
number of patients who needed to return to dialysis	2 years
number of patients with acute or chronic transplant rejection	2 years
Incremental cost-effectiveness evaluation criteria	2 years	Cost per QALY earned (QALYs estimated from the EuroQol group - 5 Dimensions ( EQ-5D) quality of life scale).

Trial Locations

Locations (2)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France

Clermont-Ferrand, CHU Site Gabriel-Montpied; 🇫🇷 Clermont-Ferrand, France