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

NCT ID: NCT03750331

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 738 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2025-12-31

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.

Conditions

Renal Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

traditional schedule

Intervention Type: OTHER

a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule

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).

Group Type: EXPERIMENTAL

Ap'Telecare

Intervention Type: OTHER

an internet application on a computer, tablet or smartphone

Interventions

Ap'Telecare

an internet application on a computer, tablet or smartphone

Intervention Type: OTHER

traditional schedule

a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No home internet access
• Major disability

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Mariat, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Clermont-Ferrand, CHU Site Gabriel-Montpied

Clermont-Ferrand, , France

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2018-A00677-48

Identifier Type: OTHER

Identifier Source: secondary_id

1708232

Identifier Type: -

Identifier Source: org_study_id