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ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

NCT04865172 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-11-21

No results posted yet for this study

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.

Conditions

  • Frontotemporal Dementia, Behavioral Variant
  • Alzheimer Disease

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER_GOV

Principal Investigators

  • Richard Levy, MD, PhD · Institut National de la Santé Et de la Recherche Médicale, France

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865172 on ClinicalTrials.gov