Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT04342520
Status:
UNKNOWN
Last Update Posted:
2023-01-06
First Post:
2020-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale', 'timeFrame': 'at inclusion', 'description': 'The anxiety score (Y-B form) of the State Trait Anxiety Inventory (STAI) scale, assess the level of anxiety in daily life. The range of this score is from 20 to 80.'}, {'measure': 'Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale', 'timeFrame': 'at 2 months', 'description': 'The anxiety score (Y-B form) of the State Trait Anxiety Inventory (STAI) scale, assess the level of anxiety in daily life. The range of this score is from 20 to 80.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Decline']}, 'descriptionModule': {'briefSummary': "Improving the diagnosis of neurocognitive disorders is a major public health challenge. This diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for some despite the presence of clinical signs and symptoms. However, the etiological diagnosis of a TNC is crucial for the patient and his family to understand the most appropriate decisions for the future, to plan the organization of his life as long as he is able to do so, to access the clinical research, to promote dialogue between patients and their caregivers. On the contrary, a late diagnosis may be responsible for the fact that the patient and his / her family are less able to benefit from certain psychosocial interventions, services and treatments.\n\nBut the diagnostic announcement is retained. One of the negative and dreaded effects of such an announcement is the negative psychological impact. Some studies show that the diagnostic announcement would worsen the level of anxiety or depressed mood and the risk of social isolation. On the other hand, other studies show that symptoms such as anxiety, psychic distress and depression remain stable, or even decrease slightly after the announcement of the diagnosis, in patients and their relatives. However, the literature is questionable because the majority of the studies are retrospective, mono-centric, and the patient numbers are low. While the first reactions of patients may be negative after the announcement, some report resignation experiences, or form of relief, because they have finally found a clinical explanation for the symptoms encountered. While doubt or diagnostic uncertainty, as well as the feeling of not knowing the truth, seem to have a more damaging psychological impact on the patient and those around him, increasing anxiety and confusion.\n\nThe primary objective is to study if the level of anxiety 2 months after the announcement of the diagnosis of Alzheimer's disease or a related disease is not superior to the level of anxiety before the announcement with patient / caregiver.\n\nThis present study aim to explore the feasibility with 14 patients.", 'detailedDescription': "Improving the diagnosis of neurocognitive disorders is a major public health challenge. This diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for some despite the presence of clinical signs and symptoms. However, the etiological diagnosis of a TNC is crucial for the patient and his family to understand the most appropriate decisions for the future, to plan the organization of his life as long as he is able to do so, to access the clinical research, to promote dialogue between patients and their caregivers. On the contrary, a late diagnosis may be responsible for the fact that the patient and his / her family are less able to benefit from certain psychosocial interventions, services and treatments.\n\nBut the diagnostic announcement is retained. One of the negative and dreaded effects of such an announcement is the negative psychological impact. Some studies show that the diagnostic announcement would worsen the level of anxiety or depressed mood and the risk of social isolation. On the other hand, other studies show that symptoms such as anxiety, psychic distress and depression remain stable, or even decrease slightly after the announcement of the diagnosis, in patients and their relatives. However, the literature is questionable because the majority of the studies are retrospective, mono-centric, and the patient numbers are low. While the first reactions of patients may be negative after the announcement, some report resignation experiences, or form of relief, because they have finally found a clinical explanation for the symptoms encountered. While doubt or diagnostic uncertainty, as well as the feeling of not knowing the truth, seem to have a more damaging psychological impact on the patient and those around him, increasing anxiety and confusion.\n\nThe primary objective is to study if the level of anxiety 2 months after the announcement of the diagnosis of Alzheimer's disease or a related disease is not superior to the level of anxiety before the announcement with patient / caregiver.\n\nThis present study aim to explore the feasibility with 14 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient / caregiver likely to participate in the study will be identified in a memory clinic as part of their regular medical course.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients :\n* Man or woman 55 years and over\n* Patient received for the first time in Memory Consultation and not aware of his diagnosis\n* Patient with a Mini-Mental State Assessment score (MMSE) ≥ 20\n* Patient accompanied by a primary caregiver\n* Patient able to provide consent to participate in research\n\nCaregiver:\n\n* The caregiver accompanies the patient and is considered as the main caregiver during the consultation\n* is able to provide consent to participate in research\n\nExclusion Criteria:\n\n* Patient living in a care homes\n* Patient protected by law (under legal protection, guardianship or trusteeship)\n* Patient with a hearing or visual impairment that does not allow to carry out assessments in Memory Consultation\n* Patient opposing research'}, 'identificationModule': {'nctId': 'NCT04342520', 'acronym': 'ADIMA', 'briefTitle': "Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases", 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': "Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases", 'orgStudyIdInfo': {'id': '2019-A02620-57'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dyads Patient / caregiver', 'type': 'OTHER', 'description': "adult patient / caregiver couples, patient are 55 years of age or older and have Alzheimer's disease or a related disease"}]}, 'contactsLocationsModule': {'locations': [{'zip': '69100', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie DAUTRICOURT, Dr', 'role': 'CONTACT', 'email': 'sophie.dautricourt@chu-lyon.fr', 'phone': '+33472432174', 'phoneExt': '+33'}], 'facility': 'Hôpital des Charpennes (HCL)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Sophie DAUTRICOURT, Dr', 'role': 'CONTACT', 'email': 'sophie.dautricourt@chu-lyon.fr', 'phone': '+334 72 43 21 74', 'phoneExt': '+33'}, {'name': 'Anthony BATHSAVANIS', 'role': 'CONTACT', 'email': 'anthony.bathsavanis@chu-lyon.fr', 'phone': '+334 72 43 22 06', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}