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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05164835
Acronym
AdHemLim
Enrollment
20
Registered
2021-12-21
Start date
2022-01-26
Completion date
2026-12-20
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allograft

Keywords

allograft, drug, acceptance

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.

Interventions

OTHERpharmaceutical 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.

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medication adherence levelmonth 12Patient'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)
Factors associated with a changemonth 12Semi-structured interview conducted at M+12 post-transplant.

Secondary

MeasureTime frameDescription
Medication adherence levelday 15Patient'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)
Factors associated with a changeday 15Semi-structured interview conducted at D+15 after discharge from hospital.
Patient's representations of their medication after transplantationday 15Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree)
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patientday 0ad hoc closed-ended questionnaire conducted prior to transplantation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026