Clinical trial NCT04342520: Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases
Official title: Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Decline
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 14
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient / caregiver likely to participate in the study will be identified in a memory clinic as part of their regular medical course.

Brief summary: 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.

But 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.

The 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.

This present study aim to explore the feasibility with 14 patients.

Detailed description: 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.

But 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.

The 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.

This present study aim to explore the feasibility with 14 patients.

Eligibility criteria: Inclusion Criteria:

* Patients :
* Man or woman 55 years and over
* Patient received for the first time in Memory Consultation and not aware of his diagnosis
* Patient with a Mini-Mental State Assessment score (MMSE) ≥ 20
* Patient accompanied by a primary caregiver
* Patient able to provide consent to participate in research

Caregiver:

* The caregiver accompanies the patient and is considered as the main caregiver during the consultation
* is able to provide consent to participate in research

Exclusion Criteria:

* Patient living in a care homes
* Patient protected by law (under legal protection, guardianship or trusteeship)
* Patient with a hearing or visual impairment that does not allow to carry out assessments in Memory Consultation
* Patient opposing research

Primary outcomes:
measure: Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale
timeFrame: at inclusion
measure: Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale
timeFrame: at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital des Charpennes (HCL)
Study officials:
References: