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NCT Number: NCT03750331

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clermont-Ferrand, CHU Site Gabriel-Montpied, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No home internet access
  • Major disability

Treatment and study plan

Ap'Telecare

Other

an internet application on a computer, tablet or smartphone

traditional schedule

Other

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

Primary outcomes

  1. Patients experiencing at least one episode of graft dysfunction

    Time frame: 2 years

    graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value)

Secondary outcomes

  1. Failure of immunosuppressive treatment

    Time frame: 2 years

    Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic

  2. number of patients who needed to return to dialysis

    Time frame: 2 years

  3. number of patients with acute or chronic transplant rejection

    Time frame: 2 years

  4. Post-transplant complication

    Time frame: 2 years

  5. Death

    Time frame: 2 years

  6. Quality of life assessed

    Time frame: 2 years

    EuroQol group - 5 Dimensions ( EQ-5D) scale

  7. Level of anxiety and depression

    Time frame: 2 years

    Hospital Anxiety and Depression (HAD) scale

  8. Incremental cost-effectiveness evaluation criteria

    Time frame: 2 years

    Cost per QALY earned (QALYs estimated from the EuroQol group - 5 Dimensions ( EQ-5D) quality of life scale).

  9. Evaluation criteria for the Budget Impact Analysis

    Time frame: 2 years

    Average cost saved per 100 patients treated in the "Ap'Telecare group" compared to the "traditional follow-up".

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: APT'x

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Nov 23, 2018
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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