Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft
NCT ID: NCT05164835
Last Updated: 2022-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-01-17
2024-01-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Experimental
pharmaceutical follow-up
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.
Interventions
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pharmaceutical follow-up
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* refusal of the patient to participate in this research
* patient unable to understand the treatment
* pregnant or breastfeeding woman
18 Years
ALL
No
Sponsors
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University Hospital, Limoges
OTHER
Responsible Party
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Locations
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Limoges University Hospital
Limoges, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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87RI21_0032 (AdHemLim)
Identifier Type: -
Identifier Source: org_study_id
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