Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-30 @ 1:37 PM
Study NCT ID:
NCT05164835
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2021-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2021-10-31', 'studyFirstSubmitQcDate': '2021-12-07', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication adherence level', 'timeFrame': 'month 12', 'description': "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)"}, {'measure': 'Factors associated with a change', 'timeFrame': 'month 12', 'description': 'Semi-structured interview conducted at M+12 post-transplant.'}], 'secondaryOutcomes': [{'measure': 'Medication adherence level', 'timeFrame': 'day 15', 'description': "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)"}, {'measure': 'Factors associated with a change', 'timeFrame': 'day 15', 'description': 'Semi-structured interview conducted at D+15 after discharge from hospital.'}, {'measure': 'Medication adherence level', 'timeFrame': 'month 3', 'description': "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)"}, {'measure': 'Factors associated with a change', 'timeFrame': 'month 3', 'description': 'Semi-structured interview conducted at M+3 post-transplant.'}, {'measure': 'Medication adherence level', 'timeFrame': 'month 6', 'description': "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)"}, {'measure': 'Factors associated with a change', 'timeFrame': 'month 6', 'description': 'Semi-structured interview conducted at M+6 post-transplant.'}, {'measure': 'Medication adherence level', 'timeFrame': 'month 9', 'description': "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)"}, {'measure': 'Factors associated with a change', 'timeFrame': 'month 9', 'description': 'Semi-structured interview conducted at M+9 post-transplant.'}, {'measure': "Patient's representations of their medication after transplantation", 'timeFrame': 'day 15', 'description': 'Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree)'}, {'measure': "Patient's representations of their medication after transplantation", 'timeFrame': 'day 15', 'description': 'semi-directive interview approach using specific items'}, {'measure': "Patient's representations of their medication after transplantation", 'timeFrame': 'month 6', 'description': 'Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree)'}, {'measure': "Patient's representations of their medication after transplantation", 'timeFrame': 'month 6', 'description': 'semi-directive interview approach using specific items'}, {'measure': "Patient's representations of their medication after transplantation", 'timeFrame': 'month 12', 'description': 'Use of the "belief about medicines" questionnaire : 18 items. Each item is rated from 0 to 5 (0 = strongly disagree, 5 = strongly agree)'}, {'measure': "Patient's representations of their medication after transplantation", 'timeFrame': 'month 12', 'description': 'semi-directive interview approach using specific items'}, {'measure': 'Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient', 'timeFrame': 'day 0', 'description': 'ad hoc closed-ended questionnaire conducted prior to transplantation'}, {'measure': 'Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient', 'timeFrame': 'month 3', 'description': 'ad hoc closed-ended questionnaire'}, {'measure': 'Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient', 'timeFrame': 'month 6', 'description': 'ad hoc closed-ended questionnaire'}, {'measure': 'Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient', 'timeFrame': 'month 12', 'description': 'ad hoc closed-ended questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allograft', 'drug', 'acceptance'], 'conditions': ['Allograft']}, 'descriptionModule': {'briefSummary': 'Allograft patients have a complex care pathway and are left with a large number of prescribed medications.\n\nThey 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.\n\nTherapeutic 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.\n\nAdherence to treatment consists of three phases:\n\n* Acceptance of the disease and the benefits of treatment,\n* Compliance: following the instructions of the prescription (dosage and schedule),\n* Persistence: consistency of compliance over time.\n\nSupport 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.)\n\nWe 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.\n\nOn 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.\n\nA recent multicentre cross-sectional study in France on adherence in allograft patients showed that 80% of adult and paediatric patients were not adherent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* allograft patients followed by the Limoges University Hospital\n\nExclusion Criteria:\n\n* patient hospitalised at the Limoges University Hospital for a reason other than allograft\n* refusal of the patient to participate in this research\n* patient unable to understand the treatment\n* pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT05164835', 'acronym': 'AdHemLim', 'briefTitle': 'Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '87RI21_0032 (AdHemLim)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Other: pharmaceutical follow-up']}], 'interventions': [{'name': 'pharmaceutical follow-up', 'type': 'OTHER', 'description': 'Pharmaceutical follow-up over 1 year and pharmaceutical interviews during the various medical consultation appointments.\n\nIn addition to the usual care:\n\n* 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.\n* Extension of the duration of the usual interview by 10 minutes in order to collect the desired information.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémy JOST, MD', 'role': 'CONTACT', 'email': 'jeremy.jost@chu-limoges.fr', 'phone': '+33(0)555 056 155'}, {'name': 'Stéphanie BONNET', 'role': 'CONTACT', 'email': 'stephanie.bonnet@chu-limoges.fr', 'phone': '+33(0)555 056 155'}], 'facility': 'Limoges University Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'centralContacts': [{'name': 'Jérémy JOST, PhamD, PhD', 'role': 'CONTACT', 'email': 'jeremy.jost@chu-limoges.fr', 'phone': '+33(0)555 056 155'}, {'name': 'Stéphanie BONNET', 'role': 'CONTACT', 'email': 'stephanie.bonnet@chu-limoges.fr', 'phone': '+33(0)555 056 155'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}