Clinical trial NCT04865172: ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions
Official title: ECOCAPTURE@HOME: Program for the Assessment of Behavioural Markers of Apathy Under Real-life Conditions Aimed At Patients with Neurodegenerative Dementias and Their Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frontotemporal Dementia, Behavioral Variant
Alzheimer Disease
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2021-04-29
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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.

Detailed description: Apathy, a common neuropsychiatric symptom associated with dementia, has a strong impact on both patients' and caregivers' quality of life. In spite of its debilitating consequences, apathy is still poorly understood and hard to define or measure objectively. The overall objective of the ECOCAPTURE programme is to define a precise behavioural signature of apathy, assessed by a multi-modal and ecological approach. This protocol called "ECOCAPTURE@HOME" aims to validate a novel method for the remote measurement of behavioural markers of apathy. The final purpose of such a protocol being to improve the diagnosis and long-term follow-up of apathy.

Investigators plan to recruit 60 couples aged between 40 and 85 years old and divided into three groups of dyads: one group of 20 patient-caregiver dyads in which patients suffer from the behavioral variant of Fronto-Temporal Dementia (bvFTD), one group of 20 patient-caregiver dyads in which patients suffer from Alzheimer Disease (AD) and one group of 20 healthy control couples. All recruited dyads will be followed in their everyday life for 28 consecutive days via a multi-sensor wearable bracelet (worn by both partners of the dyad) collecting passive behavioural data. Active behavioural data will also be collected using questionnaires available on a smartphone application (completed by caregiver in patient-caregiver dyads). Investigators will thus validate a measurement model for three theoretical behavioural markers of apathy (i.e., daytime activity, quality of sleep and emotional arousal) using a pool metrics extracted from passive behavioural data (acceleration, electrodermal activity and blood volume pulse) completed by active behavioural data (describing behaviour at meals, wake and bedtime). Moreover, investigators will investigate this measurement model on both a daily and a monthly scale and will attempt to show that the measured behavioural markers of apathy can predict caregiver's perception of the dyad's psychological state (collected through questionnaires) on these two time-scales.

This project carries great potential to improve both patients' care and caregivers' social support.

Eligibility criteria: Inclusion Criteria for patients:

1. 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;
2. No evidence of any other cerebral pathology;
3. 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);
4. Aged between 40 and 85;
5. No evidence of any psychiatric condition and a Montgomery-Åsberg Depression Rating Scale (MADRS) score inferior to 20 (to avoid confusion between depression and apathy);
6. No evidence of excessive consumption of psychotropic drugs - for instance benzodiazepines, sleeping pills, etc. (due to their tranquilising effect);
7. No major physical disability disrupting mobility;
8. No heart pacemaker (which would compromise heart rate measuring).

Inclusion Criteria for caregivers and partners of healthy control dyads:

1. Aged between 40 and 85;
2. No evidence of any psychiatric condition;
3. A MADRS score inferior to 20;
4. No evidence of excessive consumption of psychotropic drugs;
5. No major physical disability disrupting mobility;
6. No heart pacemaker.

Exclusion Criteria:

1. Persons in detention by judicial or administrative decision
2. Person who is subject to a legal protection order
3. Person submitted to an exclusion period due to the participation to another research

Primary outcomes:
measure: Acceleration (in g)
timeFrame: 28 days
measure: Electrodermal activity (in microsiemens)
timeFrame: 28 days
measure: Blood volume pulse (or relative blood flow)
timeFrame: 28 days
measure: Bedtime and getting up time (Week 1)
timeFrame: once during the first week of the follow-up
measure: Bedtime and getting up time (Week 2)
timeFrame: once during the second week of the follow-up
measure: Bedtime and getting up time (Week 3)
timeFrame: once during the third week of the follow-up
measure: Bedtime and getting up time (Week 4)
timeFrame: once during the fourth week of the follow-up
measure: Meal times (Week 1)
timeFrame: once during the first week of the follow-up
measure: Meal times (Week 2)
timeFrame: once during the second week of the follow-up
measure: Meal times (Week 3)
timeFrame: once during the third week of the follow-up
measure: Meal times (Week 4)
timeFrame: once during the fourth week of the follow-up
measure: Autonomy for going to bed and getting up (Week 1)
timeFrame: once during the first week of the follow-up
measure: Autonomy for going to bed and getting up (Week 2)
timeFrame: once during the second week of the follow-up
measure: Autonomy for going to bed and getting up (Week 3)
timeFrame: once during the third week of the follow-up
measure: Autonomy for going to bed and getting up (Week 4)
timeFrame: once during the fourth week of the follow-up
measure: Signs of tiredness (Week 1)
timeFrame: once during the first week of the follow-up
measure: Signs of tiredness (Week 2)
timeFrame: once during the second week of the follow-up
measure: Signs of tiredness (Week 3)
timeFrame: once during the third week of the follow-up
measure: Signs of tiredness (Week 4)
timeFrame: once during the fourth week of the follow-up
measure: Involvement in the activities related to meal (Week 1)
timeFrame: once during the first week of the follow-up
measure: Involvement in the activities related to meal (Week 2)
timeFrame: once during the second week of the follow-up
measure: Involvement in the activities related to meal (Week 3)
timeFrame: once during the third week of the follow-up
measure: Involvement in the activities related to meal (Week 4)
timeFrame: once during the fourth week of the follow-up
measure: Usefulness of involvement in the activities related to meal (Week 1)
timeFrame: once during the first week of the follow-up
measure: Usefulness of involvement in the activities related to meal (Week 2)
timeFrame: once during the second week of the follow-up
measure: Usefulness of involvement in the activities related to meal (Week 3)
timeFrame: once during the third week of the follow-up
measure: Usefulness of involvement in the activities related to meal (Week 4)
timeFrame: once during the fourth week of the follow-up
measure: Autonomy of the involvement in the activities related to meal (Week 1)
timeFrame: once during the first week of the follow-up
measure: Autonomy of the involvement in the activities related to meal (Week 2)
timeFrame: once during the second week of the follow-up
measure: Autonomy of the involvement in the activities related to meal (Week 3)
timeFrame: once during the third week of the follow-up
measure: Autonomy of the involvement in the activities related to meal (Week 4)
timeFrame: once during the fourth week of the follow-up
measure: Quantity of interactions during meals (Week 1)
timeFrame: once during the first week of the follow-up
measure: Quantity of interactions during meals (Week 2)
timeFrame: once during the second week of the follow-up
measure: Quantity of interactions during meals (Week 3)
timeFrame: once during the third week of the follow-up
measure: Quantity of interactions during meals (Week 4)
timeFrame: once during the fourth week of the follow-up
measure: Quality of interactions during meals (Week 1)
timeFrame: once during the first week of the follow-up
measure: Quality of interactions during meals (Week 2)
timeFrame: once during the second week of the follow-up
measure: Quality of interactions during meals (Week 3)
timeFrame: once during the third week of the follow-up
measure: Quality of interactions during meals (Week 4)
timeFrame: once during the fourth week of the follow-up
Secondary outcomes:
measure: Patient's apathy perceived by caregiver (day scale)
timeFrame: once a week during the 4 weeks of the follow-up
measure: Patient's apathy perceived by caregiver (month scale)
timeFrame: at the end of the 28-day follow-up
measure: Caregiver's burden (day scale)
timeFrame: once a week during the 4 weeks of the follow-up
measure: Caregiver's burden (month scale)
timeFrame: at the end of the 28-day follow-up
measure: Caregiver's health-related quality of life (day scale)
timeFrame: once a week during the 4 weeks of the follow-up
measure: Caregiver's health-related quality of life (month scale)
timeFrame: at the end of the 28-day follow-up
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM, Hôpital Salpêtrière
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Richard Levy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Godefroy V, Levy R, Bouzigues A, Rametti-Lacroux A, Migliaccio R, Batrancourt B. ECOCAPTURE@HOME: Protocol for the Remote Assessment of Apathy and Its Everyday-Life Consequences. Int J Environ Res Public Health. 2021 Jul 23;18(15):7824. doi: 10.3390/ijerph18157824.