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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05164835
Other study ID # 87RI21_0032 (AdHemLim)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 17, 2022
Est. completion date January 20, 2024

Study information

Verified date January 2022
Source University Hospital, Limoges
Contact Jérémy JOST, PhamD, PhD
Phone +33(0)555 056 155
Email jeremy.jost@chu-limoges.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 20, 2024
Est. primary completion date January 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France Limoges University Hospital Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medication adherence level 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) month 12
Primary Factors associated with a change Semi-structured interview conducted at M+12 post-transplant. month 12
Secondary Medication adherence level 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) day 15
Secondary Factors associated with a change Semi-structured interview conducted at D+15 after discharge from hospital. day 15
Secondary Medication adherence level 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) month 3
Secondary Factors associated with a change Semi-structured interview conducted at M+3 post-transplant. month 3
Secondary Medication adherence level 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) month 6
Secondary Factors associated with a change Semi-structured interview conducted at M+6 post-transplant. month 6
Secondary Medication adherence level 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) month 9
Secondary Factors associated with a change Semi-structured interview conducted at M+9 post-transplant. month 9
Secondary Patient's representations of their medication after transplantation Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree) day 15
Secondary Patient's representations of their medication after transplantation semi-directive interview approach using specific items day 15
Secondary Patient's representations of their medication after transplantation Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree) month 6
Secondary Patient's representations of their medication after transplantation semi-directive interview approach using specific items month 6
Secondary Patient's representations of their medication after transplantation Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree) month 12
Secondary Patient's representations of their medication after transplantation semi-directive interview approach using specific items month 12
Secondary Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient ad hoc closed-ended questionnaire conducted prior to transplantation day 0
Secondary Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient ad hoc closed-ended questionnaire month 3
Secondary Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient ad hoc closed-ended questionnaire month 6
Secondary Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient ad hoc closed-ended questionnaire month 12
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