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

NCT03750331 | Active Not Recruiting

• 2 other identifiers: 17082322018-A00677-48
• Study Type: interventional
• Target: 738
• Locations: 1 country
• Sites: 2

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

Keywords

telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Failure of immunosuppressive treatment

  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

• Death

  2 years

Study Arms (2)

traditional patient follow-up

ACTIVE COMPARATOR

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

medically-tailored follow-up with Ap'Telecare

EXPERIMENTAL

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

Interventions

Ap'Telecare OTHER

an internet application on a computer, tablet or smartphone

medically-tailored follow-up with Ap'Telecare

traditional schedule OTHER

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

traditional patient follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No home internet access
• Major disability

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (2)

Clermont-Ferrand, CHU Site Gabriel-Montpied

Clermont-Ferrand, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

Study Officials

• Christophe Mariat, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 23, 2018
• Study Start: December 17, 2018
• Primary Completion: October 10, 2023
• Study Completion: December 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)