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

Allograft Clinical Trial

— AdHemLim  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164835
• Other study ID #: 87RI21_0032 (AdHemLim)
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Allograft

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