Clinical trial NCT05164835: Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft
Official title: Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft: a Pilot Study at the University Hospital of Limoges
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allograft
Keywords: allograft
drug
acceptance
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence level
timeFrame: month 12
measure: Factors associated with a change
timeFrame: month 12
Secondary outcomes:
measure: Medication adherence level
timeFrame: day 15
measure: Factors associated with a change
timeFrame: day 15
measure: Medication adherence level
timeFrame: month 3
measure: Factors associated with a change
timeFrame: month 3
measure: Medication adherence level
timeFrame: month 6
measure: Factors associated with a change
timeFrame: month 6
measure: Medication adherence level
timeFrame: month 9
measure: Factors associated with a change
timeFrame: month 9
measure: Patient's representations of their medication after transplantation
timeFrame: day 15
measure: Patient's representations of their medication after transplantation
timeFrame: day 15
measure: Patient's representations of their medication after transplantation
timeFrame: month 6
measure: Patient's representations of their medication after transplantation
timeFrame: month 6
measure: Patient's representations of their medication after transplantation
timeFrame: month 12
measure: Patient's representations of their medication after transplantation
timeFrame: month 12
measure: Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
timeFrame: day 0
measure: Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
timeFrame: month 3
measure: Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
timeFrame: month 6
measure: Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
timeFrame: month 12
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
References: