RecruitingNCT06182787

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

Development and Validation of an Experience Sampling Method Questionnaire (ESM) for Digital Monitoring of Mental State in Psychiatric Hospitalization: Convergence of ESM Reports, Standard Clinical Assessments, and Smartwatch Data


Sponsor

Sheba Medical Center

Enrollment

130 participants

Start Date

May 18, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a system to monitor the mental state of psychiatric patients during hospital stays using digital tools. It involves focus groups with patients and clinicians to design and test digital monitoring approaches that could track mood, behavior, or other mental health indicators in real time to improve care. **You may be eligible if...** - You are currently admitted voluntarily to the psychiatric wards at Sheba Medical Center - You are able and willing to sign an informed consent form **You may NOT be eligible if...** - You have very low compliance with your treatment - You have a serious active physical illness, significant intellectual disability, or dementia - Your mental state prevents you from providing meaningful informed consent - You are admitted involuntarily Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Chaim Sheba Medical Center

Ramat Gan, Israel

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NCT06182787


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