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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT03750331

Collaborator

Ministry of Health, France (Other)

688

Enrollment

Locations

Arms

76.5

Anticipated Duration (Months)

344

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Other: Ap'Telecare Other: traditional schedule	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

688 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Non-inferiority Randomized Controlled Trial comparing Non-inferiority Randomized Controlled Trial comparing (i) 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) to (ii) a group of patients assisted by Ap'TELACARE 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).Non-inferiority Randomized Controlled Trial comparing Non-inferiority Randomized Controlled Trial comparing (i) 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) to (ii) a group of patients assisted by Ap'TELACARE 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).

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 17, 2018

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]
Post-transplant complication [2 years]
Death [2 years]
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
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).
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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients transplanted for at least 3 months
Stable renal graft function

Exclusion Criteria:

No home internet access
Major disability

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clermont-Ferrand, CHU Site Gabriel-Montpied	Clermont-Ferrand		France
2	CHU Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France

Investigators

Principal Investigator: Christophe Mariat, MD PhD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT03750331

Other Study ID Numbers:

1708232
2018-A00677-48

First Posted:

Nov 23, 2018

Last Update Posted:

Dec 2, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

telemedicine

Study Results

No Results Posted as of Dec 2, 2021