AllograftAdHemLimNCT05164835
Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft
A study testing pharmaceutical follow-up in people with Allograft, run by University Hospital, Limoges at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allograft
- What is being tested?
- pharmaceutical follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2022to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- allograft patients followed by the Limoges University Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Allograft
- Being tested
- pharmaceutical follow-up
- Keywords
- allograft, drug, acceptance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical follow-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: pharmaceutical follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: month 12
Factors associated with a change
Semi-structured interview conducted at M+12 post-transplant.
Measured: month 12
Secondary outcomes (18)
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)
Measured: day 15
Factors associated with a change
Semi-structured interview conducted at D+15 after discharge from hospital.
Measured: 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)
Measured: month 3
Factors associated with a change
Semi-structured interview conducted at M+3 post-transplant.
Measured: 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)
Measured: month 6
Factors associated with a change
Semi-structured interview conducted at M+6 post-transplant.
Measured: 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)
Measured: month 9
Factors associated with a change
Semi-structured interview conducted at M+9 post-transplant.
Measured: 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)
Measured: day 15
Patient's representations of their medication after transplantation
semi-directive interview approach using specific items
Measured: 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)
Measured: month 6
Patient's representations of their medication after transplantation
semi-directive interview approach using specific items
Measured: 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)
Measured: month 12
Patient's representations of their medication after transplantation
semi-directive interview approach using specific items
Measured: 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
Measured: day 0
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
ad hoc closed-ended questionnaire
Measured: month 3
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
ad hoc closed-ended questionnaire
Measured: month 6
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
ad hoc closed-ended questionnaire
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start26 Jan 2022
- Primary completion27 Jan 2025
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllograftStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164835
- Sponsor's protocol ID
- 87RI21_0032 (AdHemLim)
- Acronym
- AdHemLim
- Status last verified
- Jun 2026
- First submitted
- 31 Oct 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05164835
- Acronym / sponsor ID
- AdHemLim / 87RI21_0032 (AdHemLim)
- Conditions
- Allograft
- Keywords
- allograft, drug, acceptance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: pharmaceutical follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- allograft patients followed by the Limoges University Hospital
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmaceutical follow-upPharmaceutical 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. | Other | Experimental |
Primary outcome
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)
Factors associated with a change
Time frame: month 12
Semi-structured interview conducted at M+12 post-transplant.
18 secondary outcomes
Medication adherence level
Time frame: day 15
Factors associated with a change
Time frame: day 15
Medication adherence level
Time frame: month 3
Factors associated with a change
Time frame: month 3
Medication adherence level
Time frame: month 6
Factors associated with a change
Time frame: month 6
Medication adherence level
Time frame: month 9
Factors associated with a change
Time frame: month 9
Patient's representations of their medication after transplantation
Time frame: day 15
Patient's representations of their medication after transplantation
Time frame: day 15
Patient's representations of their medication after transplantation
Time frame: month 6
Patient's representations of their medication after transplantation
Time frame: month 6
Patient's representations of their medication after transplantation
Time frame: month 12
Patient's representations of their medication after transplantation
Time frame: month 12
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
Time frame: day 0
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
Time frame: month 3
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
Time frame: month 6
Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient
Time frame: month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical follow-up in people with Allograft, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence level (time frame: month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.