ADIMA: Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04342520
Collaborator
(none)
14
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dyads Patient / caregiver

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
14 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale [at inclusion]

    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.

  2. Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale [at 2 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04342520
Other Study ID Numbers:
  • 2019-A02620-57
First Posted:
Apr 13, 2020
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022