Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04342520 |
| Other study ID # |
2019-A02620-57 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 16, 2022 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Hospices Civils de Lyon |
| Contact |
Sophie DAUTRICOURT, Dr |
| Phone |
+334 72 43 21 74 |
| Email |
sophie.dautricourt[@]chu-lyon.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
