NCT05164835

Brief Summary

Allograft patients have a complex care pathway and are left with a large number of prescribed medications. They have to deal with changes linked to the transplant (change in taste, fatigue, regular monitoring, risk of GVH (graft versus host) complications, infectious risks, change in eating habits, etc.), and a large number of associated drugs (immunosuppressants, anti-infectious prophylaxis and supplements (folic acid, magnesium, bile salts, etc.), which are added to any pre-existing chronic pathologies. Therapeutic adherence of these patients is a real challenge. Indeed, the success of the transplant and the complications that may arise (graft rejection, GVH, infections, death, hospitalisation, etc.) are closely linked to good or poor therapeutic adherence. Moreover, the majority of these patients are young and are not used to taking many treatments, which will change after the transplant. Adherence to treatment consists of three phases:

  • Acceptance of the disease and the benefits of treatment,
  • Compliance: following the instructions of the prescription (dosage and schedule),
  • Persistence: consistency of compliance over time. Support from the care team throughout the management of these patients is necessary for good therapeutic adherence in order to prevent and act early on the difficulties encountered (appearance of side effects linked to the treatments, large number of tablets per day, duration of treatment (1 to 2 years), risk of GVH, significant asthenia and difficulty in concentrating, etc.) We have a large amount of data on therapeutic adherence and potential non-adherence factors in patients with chronic diseases (diabetes, asthma, cancer, etc.) or in solid organ transplant patients. On the other hand, there is little data on allograft patients. Most often, a parallel is made between the data present in kidney transplant patients and allograft patients. However, it is necessary to study more specifically the therapeutic adherence in this population. A recent multicentre cross-sectional study in France on adherence in allograft patients showed that 80% of adult and paediatric patients were not adherent.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 31, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

June 1, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

October 31, 2021

Last Update Submit

May 30, 2022

Conditions

Allograft

Keywords

allograftdrugacceptance

Outcome Measures

Primary Outcomes (2)

  • Medication adherence level

    Patient's level of medication adherence will be assessed by the 8-item Morisky test (score 0 to 13 : a score greater than or equal to 11 show good adherence)

    month 12

  • Factors associated with a change

    Semi-structured interview conducted at M+12 post-transplant.

    month 12

Secondary Outcomes (18)

  • Medication adherence level

    day 15

  • Factors associated with a change

    day 15

  • Medication adherence level

    month 3

  • Factors associated with a change

    month 3

  • Medication adherence level

    month 6

  • +13 more secondary outcomes

Study Arms (1)

Experimental

EXPERIMENTAL
Other: pharmaceutical follow-up

Interventions

pharmaceutical follow-upOTHER

Pharmaceutical follow-up over 1 year and pharmaceutical interviews during the various medical consultation appointments. In addition to the usual care: * Delivery of questionnaire at the time defined in the protocol. The questionnaires will be given during the waiting time of the patients at the University Hospital of Limoges. * Extension of the duration of the usual interview by 10 minutes in order to collect the desired information.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • allograft patients followed by the Limoges University Hospital

You may not qualify if:

  • patient hospitalised at the Limoges University Hospital for a reason other than allograft
  • refusal of the patient to participate in this research
  • patient unable to understand the treatment
  • pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges University Hospital

Limoges, 87042, France

RECRUITING

Central Study Contacts

Jérémy JOST, PhamD, PhD

CONTACT

+33(0)555 056 155jeremy.jost@chu-limoges.fr

Stéphanie BONNET

CONTACT

+33(0)555 056 155stephanie.bonnet@chu-limoges.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2021

First Posted

December 21, 2021

Study Start

January 17, 2022

Primary Completion

January 20, 2024

Study Completion

January 20, 2024

Last Updated

June 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)