Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft (AdHemLim)

University of Limoges (UL)

Status: Unknown

Conditions: Allograft

Treatments: Other: pharmaceutical follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT05164835

87RI21_0032 (AdHemLim)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• allograft patients followed by the Limoges University Hospital

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental

Experimental group

Treatment:

Other: pharmaceutical follow-up