NCT04865172

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

March 24, 2021

Last Update Submit

November 19, 2024

Conditions

Frontotemporal Dementia, Behavioral VariantAlzheimer Disease

Outcome Measures

Primary Outcomes (39)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Patient's apathy perceived by caregiver (day scale)

    once a week during the 4 weeks of the follow-up

  • Patient's apathy perceived by caregiver (month scale)

    at the end of the 28-day follow-up

  • Caregiver's burden (day scale)

    once a week during the 4 weeks of the follow-up

  • Caregiver's burden (month scale)

    at the end of the 28-day follow-up

  • Caregiver's health-related quality of life (day scale)

    once a week during the 4 weeks of the follow-up

  • +1 more secondary outcomes

Study Arms (3)

Patient-caregiver dyads, patients with behavioural variant frontotemporal dementia

20 patient-caregiver dyads, patients with behavioural variant frontotemporal dementia

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

Patient-caregiver dyads, patients with Alzheimer disease

20 patient-caregiver dyads, patients with Alzheimer disease

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

Healthy control dyads

20 healthy control dyads

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

Interventions

Remote collection of passive and active data for 28 consecutive daysOTHER

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.

Healthy control dyadsPatient-caregiver dyads, patients with Alzheimer diseasePatient-caregiver dyads, patients with behavioural variant frontotemporal dementia

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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;
  • 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);
  • No evidence of excessive consumption of psychotropic drugs - for instance benzodiazepines, sleeping pills, etc. (due to their tranquilising effect);
  • No major physical disability disrupting mobility;
  • No heart pacemaker (which would compromise heart rate measuring).
  • Aged between 40 and 85;
  • No evidence of any psychiatric condition;
  • A MADRS score inferior to 20;
  • No evidence of excessive consumption of psychotropic drugs;
  • No major physical disability disrupting mobility;
  • No heart pacemaker.

You may not qualify if:

  • Persons in detention by judicial or administrative decision
  • Person who is subject to a legal protection order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICM, Hôpital Salpêtrière

Paris, 75013, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34360133DERIVED

MeSH Terms

Conditions

Pick Disease of the BrainAlzheimer Disease

Condition Hierarchy (Ancestors)

Frontotemporal DementiaFrontotemporal Lobar DegenerationDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Richard Levy, MD, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Levy, MD, PhD

CONTACT

01 49 28 24 32richard.levy@aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 29, 2021

Study Start

May 20, 2022

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

FR(1)