ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
About this trial
ECOCAPTURE@HOME is a study which is currently being developed with the objective to capture the behavioral signature of apathy in everyday life context through remote monitoring of participants' behavior for about one month. Participants will not only be patients with apathy but also their spouse caregiver. Behavioral markers of apathy will be extracted from a combination of: 1/ objective physiological data from sensors on a bracelet worn by participants; 2/ subjective data filled by the caregiver through an application. Thus investigators will collect a pool of metrics and show they can measure three assumed behavioral markers of apathy (daytime activity, quality of sleep and emotional arousal), which in turn allow to predict caregiver's perception of the dyad's psychological state. The final goal is to lay the foundations for the development of a clinical tool for the remote follow-up of patient-caregiver couples.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of bvFTD according to Rascovsky's international criteria for the bvFTD group / diagnosis of AD according to Dubois's international criteria for the AD group;
No evidence of any other cerebral pathology;
A Mini-Mental State Evaluation (MMSE) score superior or equal to 10 (to minimise the effect of confounding factors related to very severe cognitive impairment);
Aged between 40 and 85;
Disqualifiers
Persons in detention by judicial or administrative decision
Person who is subject to a legal protection order
Person submitted to an exclusion period due to the participation to another research
Trial population
20 patient-caregiver dyads with patients suffering from behavioral variant front-temporal dementia, 20 patient-caregiver dyads with patients suffering from Alzheimer disease, 20 healthy control dyads
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Remote collection of passive and active data for 28 consecutive days
Other interventionPassive sensor data: collected continuously for 28 days, from a multi-sensor wearable bracelet worn by each member of the dyad; Active questionnaire data: collected once a week during the four weeks of monitoring (and at the end of the 28 days for patient-caregiver dyads), from questionnaires filled by one partner of the dyad (for patient-caregiver dyads, this will be the caregiver) using a smartphone application.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Patient-caregiver dyads, patients with behavioural variant frontotemporal dementia1 intervention
Group B: Patient-caregiver dyads, patients with Alzheimer disease1 intervention
Group C: Healthy control dyads1 intervention
Trial outcomes
Primary outcomes
1
Acceleration (in g)
In all the dyads included in the study for a remote follow-up, investigators will collect the acceleration signal recorded by a bracelet (Empatica E4) including a 3-axis accelerometer, continuously for 28 days. Data of acceleration will be collected in both partners of the dyad.
Time frame
28 days2
Electrodermal activity (in microsiemens)
In all the dyads included in the study for a remote follow-up, investigators will collect the electrodermal activity signal recorded by a bracelet (Empatica E4) including an EDA sensor, continuously for 28 days. Data of electrodermal activity will be collected in both partners of the dyad.
Time frame
28 days3
Blood volume pulse (or relative blood flow)
In all the dyads included in the study for a remote follow-up, investigators will collect the blood volume pulse recorded by a bracelet (Empatica E4) including a photoplethysmogram (PPG) sensor, continuously for 28 days. Data of blood volume pulse will be collected in both partners of the dyad. Heart rate (number of beats per minute) can be derived from the blood volume pulse.
Time frame
28 days4
Bedtime and getting up time (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Time frame
once during the first week of the follow-upSecondary outcomes
1
Patient's apathy perceived by caregiver (day scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of patient's apathy perceived by caregiver on a day scale (once a week), caregivers have to complete one question: "How did you perceive your partner's level of apathy (= lack of ability to initiate activities) during the day?" using a visual analogue scale from "Very low" to "Very high".
Time frame
once a week during the 4 weeks of the follow-up2
Patient's apathy perceived by caregiver (month scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of patient's apathy perceived by caregiver on the month scale (at the end of the 28 days of follow-up), investigators use a validated questionnaire: Starkstein Apathy Scale (SAS) in caregiver's version (Starkstein et al., 1992). SAS score varies between 0 and 42, higher score meaning higher apathy.
Time frame
at the end of the 28-day follow-up3
Caregiver's burden (day scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of caregiver's burden on a day scale (once a week), caregivers have to complete one question: "How did you perceive the level of burden related to your partner's care during the day?" using a visual analogue scale from "Very low" to "Very high".
Time frame
once a week during the 4 weeks of the follow-up4
Caregiver's burden (month scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of caregiver's burden on the month scale (at the end of the 28 days of follow-up), investigators use a validated questionnaire: Zarit Burden Interview (ZBI) (Hébert et al., 2010). ZBI score varies between 0 and 48, higher score meaning higher perceived burden.
Time frame
at the end of the 28-day follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov