Limoges University Hospital
Limoges, 87042, France
NCT Number: NCT05164835
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Limoges, 87042, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pharmaceutical follow-up over 1 year and pharmaceutical interviews during the various medical consultation appointments.
In addition to the usual care:
Time frame: month 12
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)
Time frame: month 12
Semi-structured interview conducted at M+12 post-transplant.
Time frame: day 15
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)
Time frame: day 15
Semi-structured interview conducted at D+15 after discharge from hospital.
Time frame: month 3
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)
Time frame: month 3
Semi-structured interview conducted at M+3 post-transplant.
Time frame: month 6
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)
Time frame: month 6
Semi-structured interview conducted at M+6 post-transplant.
Time frame: month 9
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)
Time frame: month 9
Semi-structured interview conducted at M+9 post-transplant.
Time frame: day 15
Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree)
Time frame: day 15
semi-directive interview approach using specific items
Time frame: month 6
Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree)
Time frame: month 6
semi-directive interview approach using specific items
Time frame: month 12
Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree)
Time frame: month 12
semi-directive interview approach using specific items
Time frame: day 0
ad hoc closed-ended questionnaire conducted prior to transplantation
Time frame: month 3
ad hoc closed-ended questionnaire
Time frame: month 6
ad hoc closed-ended questionnaire
Time frame: month 12
ad hoc closed-ended questionnaire
University Hospital, Limoges
Other
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
Acronym: AdHemLim
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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