Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient. (APT'x)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Renal Transplantation
• Intervention / Treatment: Other: traditional schedule; Other: Ap'Telecare

• Study Type: Interventional
• Enrollment (Actual): 738
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Clermont-Ferrand, CHU Site Gabriel-Montpied
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No home internet access
• Major disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: traditional patient follow-up; 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)	Other: traditional schedule; a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule
Experimental: medically-tailored follow-up with 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).	Other: Ap'Telecare; an internet application on a computer, tablet or smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		2 years
Failure of immunosuppressive treatment	Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic	2 years
number of patients who needed to return to dialysis		2 years
number of patients with acute or chronic transplant rejection		2 years
Post-transplant complication		2 years
Quality of life assessed	EuroQol group - 5 Dimensions ( EQ-5D) scale	2 years
Level of anxiety and depression	Hospital Anxiety and Depression (HAD) scale	2 years
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Christophe Mariat, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): October 10, 2023
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: telemedicine
• Other Study ID Numbers: 1708232; 2018-A00677-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No