Establishment of a Personalized Pharmaceutical Plan in Renal or Hepatic Transplant Patients
GREPH
Mise en Place d'un Plan Pharmaceutique Personnalisé Chez Les Patients transplantés rénaux ou hépatiques : Essai randomisé en Cluster de Type Stepped-wedge.
3 other identifiers
interventional
1,716
1 country
12
Brief Summary
The main objective of the study is to evaluate the impact of the Personalized Pharmaceutical Plan on the therapeutic adherence to immunosuppressive treatments one year after liver or kidney transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
October 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2025
CompletedNovember 3, 2022
November 1, 2022
1.9 years
March 2, 2020
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Therapeutic adhesion
The Investigator will consider that a patient is in therapeutic adhesion thanks to two methods : use of the BAASIS® questionnaire (if answer \<1 for at least one of the 4 questions in the score, the patient will be considered as a non-adherent) and use of the health insurance data from the national health data system (checking that 100% of the days are covered by possession of immunosuppressive drugs)
1 year after transplantation
Secondary Outcomes (8)
Drug adherence of all chronic treatments prescribed to the patient (except immunosuppression (IS) drug)
1 year after transplantation
Knowledge of hygienic-dietetic rules and drug intake modalities
1 year after transplantation
Occurrence of adverse effects
At month 1,month 3, and 12 months after transplantation
Fate of the graft
1 year and 3 years after transplantation
Assessing patient, medical, and community pharmacist satisfaction
1 year after transplantation
- +3 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALImplementation of a personalized pharmaceutical plan with a view to increasing the patient's therapeutic education in the hospital and in the community (entrance and discharge reconciliation, 3 pharmaceutical interviews in the hospital, strengthening of the community-hospital link , 3 outpatient pharmaceutical consultations)
Usual care period
NO INTERVENTIONNo changes to usual center practices
Interventions
Personalized Pharmaceutical Plan on therapeutic adherence to immunosuppressive treatments after the transplantation
Eligibility Criteria
You may qualify if:
- Patient ≥ 18 years old
- Patient having given his free, informed and express consent
- Patient with a kidney or liver transplantation performed in the 10 participating university hospital centers
- Patient speaking french
- Patient whose main residence is in France and has no project of moving during the study period
- Patient declaring to attend the same pharmacy
- Social insured patient
You may not qualify if:
- Patient protected: safeguard of justice, curatorship, tutelage
- Patient having a double liver / kidney transplantation with a center not participating in the study
- Patients with a double organ transplantation kidney /hart
- Patient already transplanted regardless of the organ
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
CHU-BREST - Pharmacie clinique La Cavale Blanche
Brest, 29609, France
APHM - Service de Pharmacie Clinique; Hôpital de la Timone
Marseille, 13385, France
APHM Service Pharmacie- Hôpital de la Conception
Marseille, 13385, France
CHU-Montpellier Service Pharmacie Lapeyronie
Montpellier, 34000, France
CHU-NANTES Service de Pharmacie
Nantes, 44000, France
CHU-POITIERS Service de Pharmacie
Poitiers, 86021, France
CHU-REIMS Service de Pharmacie -Robert Debré
Reims, 51092, France
CHU-RENNES Pôle Pharmacie, Unité de pharmacie clinique
Rennes, 35000, France
CHU-STRASBOURG Service Pharmacie, Hôpital Hautepierre
Strasbourg, 67200, France
CHU-TOULOUSE Pôle Pharmacie PURPAN
Toulouse, 31059, France
CHU-TOURS Hôpital Bretonneau
Tours, 37044, France
CHU-TOURS-Hôpital TROUSSEAU
Tours, 37044, France
Related Publications (1)
Pourrat X, Berthy E, Dupuis A, Barbier L, Buchler M, Guillon LG, Monmousseau F, Ruspini E, Salame E, Houdard SB, Giraudeau B. Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH). Trials. 2021 Nov 8;22(1):782. doi: 10.1186/s13063-021-05749-w.
PMID: 34749777DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xavier POURRAT, PhD
University Hospital of TOURS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 5, 2020
Study Start
October 12, 2020
Primary Completion
September 11, 2022
Study Completion
September 11, 2025
Last Updated
November 3, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share