ECOCAPTURE@HOME: Protocol for the Remote Assessment of Apathy and Its Everyday-Life Consequences.
Valérie Godefroy, Richard Levy, Arabella Bouzigues...
https://pubmed.ncbi.nlm.nih.gov/34360133Actively Recruiting
Age: 40Years - 85Years
All Genders
Healthy Volunteers
ID04865172
ECOCAPTURE@HOME: Program for the Assessment of Behavioural Markers of Apathy Under Real-life Conditions Aimed At Patients with Neurodegenerative Dementias and Their Caregivers
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2024-11-21
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to identify and measure behavioral signs of apathy in daily life among patients with neurodegenerative dementias and their caregivers. The study involves groups of patient-caregiver pairs affected by behavioral variant Frontotemporal Dementia (bvFTD), Alzheimer Disease (AD), and healthy control couples. The goal is to develop a remote monitoring tool to better understand and track apathy, which greatly affects quality of life but is difficult to define and measure objectively. Participants will wear a multi-sensor bracelet continuously for 28 days to collect passive data like physical activity, electrodermal activity, and blood volume pulse. Caregivers will also complete weekly questionnaires via a smartphone app about behaviors related to meals, sleep, and daily activities. The study compares data from three groups: bvFTD patient-caregiver dyads, AD patient-caregiver dyads, and healthy control dyads. During the 28-day period, researchers will gather continuous sensor data and weekly questionnaire responses to evaluate three key behavioral markers of apathy: daytime activity, sleep quality, and emotional arousal. They will analyze these markers on daily and monthly scales and assess how well they predict caregivers' perceptions of psychological states. This monitoring may help improve future care and support for patients and their caregivers.
CONDITIONS
Brief Title
ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions
Who Can Participate
Age: 40Years - 85Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with behavioral variant Frontotemporal Dementia (bvFTD) or Alzheimer Disease (AD) according to international criteria
- Aged between 40 and 85 years old
- Mini-Mental State Evaluation (MMSE) score of 10 or higher
- No evidence of other brain diseases
- No psychiatric conditions and a Montgomery-Åsberg Depression Rating Scale (MADRS) score below 20
- No excessive use of psychotropic drugs such as benzodiazepines or sleeping pills
- No major physical disability affecting mobility
- No heart pacemaker
- Caregivers and healthy control partners aged between 40 and 85 years old
- Caregivers with no psychiatric conditions and MADRS score below 20
- Caregivers with no excessive use of psychotropic drugs
- Caregivers with no major physical disability affecting mobility
- Caregivers with no heart pacemaker
You will not qualify if you...
- Persons detained by judicial or administrative decision
- Persons under legal protection orders
- Persons excluded due to participation in another research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 28 consecutive days
Participants wear a multi-sensor wearable bracelet to collect passive behavioral data continuously. Active behavioral data is collected through weekly questionnaires completed by caregivers in patient-caregiver dyads using a smartphone application.
Weekly visits for questionnaires during the 4 weeks
Trial Site Locations
Total: 1 location
1
ICM, Hôpital Salpêtrière
Paris, France, 75013
Actively Recruiting
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Research Team
R
Richard Levy, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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