ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

Alzheimer Disease Clinical Trial

— @HOME  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04865172
• Other study ID #: C20-23
• Secondary ID: 2020-A03305-34
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: September 2023

Study information

• Verified date: April 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Richard Levy, MD, PhD
• Phone: 01 49 28 24 32
• Email: richard.levy[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Frontotemporal Dementia, Behavioral Variant
• Pick Disease of the Brain

Intervention

Other:
• Remote collection of passive and active data for 28 consecutive days
Passive 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days
Primary	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.	28 days
Primary	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.	28 days
Primary	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.	once during the first week of the follow-up
Primary	Bedtime and getting up time (Week 2)	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.	once during the second week of the follow-up
Primary	Bedtime and getting up time (Week 3)	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.	once during the third week of the follow-up
Primary	Bedtime and getting up time (Week 4)	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.	once during the fourth week of the follow-up
Primary	Meal times (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 meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the first week of the follow-up
Primary	Meal times (Week 2)	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 meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the second week of the follow-up
Primary	Meal times (Week 3)	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 meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the third week of the follow-up
Primary	Meal times (Week 4)	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 meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the fourth week of the follow-up
Primary	Autonomy for going to bed and getting up (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 two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the first week of the follow-up
Primary	Autonomy for going to bed and getting up (Week 2)	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 two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the second week of the follow-up
Primary	Autonomy for going to bed and getting up (Week 3)	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 two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the third week of the follow-up
Primary	Autonomy for going to bed and getting up (Week 4)	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 two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the fourth week of the follow-up
Primary	Signs of tiredness (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 two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the first week of the follow-up
Primary	Signs of tiredness (Week 2)	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 two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the second week of the follow-up
Primary	Signs of tiredness (Week 3)	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 two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the third week of the follow-up
Primary	Signs of tiredness (Week 4)	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 two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the fourth week of the follow-up
Primary	Involvement in the activities related to meal (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 three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the first week of the follow-up
Primary	Involvement in the activities related to meal (Week 2)	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 three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the second week of the follow-up
Primary	Involvement in the activities related to meal (Week 3)	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 three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the third week of the follow-up
Primary	Involvement in the activities related to meal (Week 4)	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 three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the fourth week of the follow-up
Primary	Usefulness of involvement in the activities related to meal (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 three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the first week of the follow-up
Primary	Usefulness of involvement in the activities related to meal (Week 2)	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 three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the second week of the follow-up
Primary	Usefulness of involvement in the activities related to meal (Week 3)	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 three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the third week of the follow-up
Primary	Usefulness of involvement in the activities related to meal (Week 4)	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 three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the fourth week of the follow-up
Primary	Autonomy of the involvement in the activities related to meal (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 three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the first week of the follow-up
Primary	Autonomy of the involvement in the activities related to meal (Week 2)	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 three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the second week of the follow-up
Primary	Autonomy of the involvement in the activities related to meal (Week 3)	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 three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the third week of the follow-up
Primary	Autonomy of the involvement in the activities related to meal (Week 4)	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 three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the fourth week of the follow-up
Primary	Quantity of interactions during meals (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 three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the first week of the follow-up
Primary	Quantity of interactions during meals (Week 2)	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 three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the second week of the follow-up
Primary	Quantity of interactions during meals (Week 3)	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 three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the third week of the follow-up
Primary	Quantity of interactions during meals (Week 4)	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 three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the fourth week of the follow-up
Primary	Quality of interactions during meals (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 three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the first week of the follow-up
Primary	Quality of interactions during meals (Week 2)	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 three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the second week of the follow-up
Primary	Quality of interactions during meals (Week 3)	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 three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the third week of the follow-up
Primary	Quality of interactions during meals (Week 4)	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 three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.	once during the fourth week of the follow-up
Secondary	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".	once a week during the 4 weeks of the follow-up
Secondary	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.	at the end of the 28-day follow-up
Secondary	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".	once a week during the 4 weeks of the follow-up
Secondary	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.	at the end of the 28-day follow-up
Secondary	Caregiver's health-related quality of life (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 quality of life on a day scale (once a week), caregivers have to complete one question: "How did you perceive your overall health state (physical and psychological) during the day?" using a visual analogue scale from "Very bad health state" to "Very good health state".	once a week during the 4 weeks of the follow-up
Secondary	Caregiver's health-related quality of life (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 quality of life on the month scale (at the end of the 28 days of follow-up), investigators use a validated questionnaire: Short Form 36 (SF36) (Stewart, 2007). The SF-36 consists of eight scaled scores on a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at the end of the 28-day follow-up