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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allograft
• Intervention / Treatment: Other: pharmaceutical follow-up

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérémy JOST, PhamD, PhD; Phone Number: +33(0)555 056 155; Email: jeremy.jost@chu-limoges.fr
• Study Contact Backup: Name: Stéphanie BONNET; Phone Number: +33(0)555 056 155; Email: stephanie.bonnet@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87042
    • Recruiting
    • Limoges university hospital
    • Contact: Stéphanie BONNET; Phone Number: +33(0)555 056 155; Email: stephanie.bonnet@chu-limoges.fr
    • Contact: Jérémy JOST, MD; Phone Number: +33(0)555 056 155; Email: jeremy.jost@chu-limoges.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Factors associated with a change	Semi-structured interview conducted at M+12 post-transplant.	month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Factors associated with a change	Semi-structured interview conducted at D+15 after discharge from hospital.	day 15
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
Factors associated with a change	Semi-structured interview conducted at M+3 post-transplant.	month 3
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
Factors associated with a change	Semi-structured interview conducted at M+6 post-transplant.	month 6
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
Factors associated with a change	Semi-structured interview conducted at M+9 post-transplant.	month 9
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
Patient's representations of their medication after transplantation	semi-directive interview approach using specific items	day 15
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
Patient's representations of their medication after transplantation	semi-directive interview approach using specific items	month 6
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
Patient's representations of their medication after transplantation	semi-directive interview approach using specific items	month 12
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
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient	ad hoc closed-ended questionnaire	month 3
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient	ad hoc closed-ended questionnaire	month 6
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient	ad hoc closed-ended questionnaire	month 12

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Anticipated): January 20, 2024
• Study Completion (Anticipated): January 20, 2024

Study Registration Dates

• First Submitted: October 31, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: allograft; drug; acceptance
• Other Study ID Numbers: 87RI21_0032 (AdHemLim)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No