Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05164835

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges University Hospital

Limoges, 87042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmaceutical follow-up

Other

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.

Primary outcomes

  1. Medication adherence level

    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)

  2. Factors associated with a change

    Time frame: month 12

    Semi-structured interview conducted at M+12 post-transplant.

Secondary outcomes

  1. Medication adherence level

    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)

  2. Factors associated with a change

    Time frame: day 15

    Semi-structured interview conducted at D+15 after discharge from hospital.

  3. Medication adherence level

    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)

  4. Factors associated with a change

    Time frame: month 3

    Semi-structured interview conducted at M+3 post-transplant.

  5. Medication adherence level

    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)

  6. Factors associated with a change

    Time frame: month 6

    Semi-structured interview conducted at M+6 post-transplant.

  7. Medication adherence level

    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)

  8. Factors associated with a change

    Time frame: month 9

    Semi-structured interview conducted at M+9 post-transplant.

  9. Patient's representations of their medication after transplantation

    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)

  10. Patient's representations of their medication after transplantation

    Time frame: day 15

    semi-directive interview approach using specific items

  11. Patient's representations of their medication after transplantation

    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)

  12. Patient's representations of their medication after transplantation

    Time frame: month 6

    semi-directive interview approach using specific items

  13. Patient's representations of their medication after transplantation

    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)

  14. Patient's representations of their medication after transplantation

    Time frame: month 12

    semi-directive interview approach using specific items

  15. Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient

    Time frame: day 0

    ad hoc closed-ended questionnaire conducted prior to transplantation

  16. Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient

    Time frame: month 3

    ad hoc closed-ended questionnaire

  17. Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient

    Time frame: month 6

    ad hoc closed-ended questionnaire

  18. Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient

    Time frame: month 12

    ad hoc closed-ended questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study 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

Acronym: AdHemLim

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 21, 2021
Registry last updated
Jun 26, 2026

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.

Published trials that share one or more normalized conditions with this study.