ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

NCT ID: NCT04865172

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2025-05-31

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.

Conditions

Frontotemporal Dementia, Behavioral Variant; Alzheimer Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patient-caregiver dyads, patients with behavioural variant frontotemporal dementia

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

Remote collection of passive and active data for 28 consecutive days

Intervention Type: OTHER

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.

Patient-caregiver dyads, patients with Alzheimer disease

20 patient-caregiver dyads, patients with Alzheimer disease

Remote collection of passive and active data for 28 consecutive days

Intervention Type: OTHER

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 dyads

20 healthy control dyads

Remote collection of passive and active data for 28 consecutive days

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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).

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Levy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

ICM, Hôpital Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Richard Levy, MD, PhD

Role: CONTACT

richard.levy@aphp.fr

01 49 28 24 32

Facility Contacts

Richard Levy

Role: primary

richard.levy@aphp.fr

+331 49 28 24 32

References

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.

Reference Type: DERIVED

PMID: 34360133 (View on PubMed)

Other Identifiers

2020-A03305-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

C20-23

Identifier Type: -

Identifier Source: org_study_id