Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06182787

Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient

Led by Sheba Medical Center · Updated on 2024-06-25

130

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study presents the development and validation of a unique Digital Experience Sampling Method (ESM) questionnaire specifically adapted for monitoring changes in the mental state of patients during psychiatric hospitalization. The questionnaire was carefully crafted through focus groups involving patients and clinical staff, ensuring its relevance and applicability to the unique characteristics of mental state changes in a hospitalization setting. To evaluate the validity of the ESM questionnaire, symptom severity trends obtained from the questionnaire will be compared with estimates derived from the Positive and Negative Syndrome Scale (PANSS) assessment. Data will be collected from 100 subjects over a 14-day psychiatric hospitalization period. In addition to the ESM questionnaire, smartwatch sensors will monitor physiological indicators. Feasibility and patient compliance will be assessed by examining patients' willingness to use the digital ESM questionnaires and the smartwatch sensors. The study will also cross-reference self-reported sleep quality and activity levels captured in the ESM questionnaires with objective physiological indicators and nursing staff reports, providing insights into the reliability of the patient-reported data. Furthermore, the study will evaluate the impact of the ESM data on clinical decision-making by physicians throughout the 14-day psychiatric hospitalization period. Patient satisfaction and satisfaction among the multidisciplinary team with the monitoring model will also be assessed. This research underscores the potential of digital technologies to enhance patient-centered care and facilitate informed treatment decisions in psychiatric hospitalization settings.

CONDITIONS

Official Title

Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults hospitalized with consent in the psychiatric wards at Sheba Medical Center
  • Signed informed consent to participate in the study
  • Staying in the open part of the ward
  • Owns a mobile smartphone
  • Multi-disciplinary team members working in psychiatric inpatient wards with a valid Israeli license
Not Eligible

You will not qualify if you...

  • Patients with low compliance to treatment
  • Patients with significant active physical illness, intellectual disability, or complex organic conditions including dementia
  • Patients who cannot read and write in Hebrew
  • Patients unable to give informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chaim Sheba Medical Center

Ramat Gan, Israel

Actively Recruiting

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Research Team

H

Hilla Mordechai, MA

CONTACT

M

Mark Weiser, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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