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RECRUITING

NCT06182787

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

Sponsor: Sheba Medical Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2022-05-18

Completion Date

2024-10-18

Last Updated

2024-06-25

Healthy Volunteers

Yes

Conditions

Severe Mental Disorder Schizophrenia Personality Disorders Mood Disorders Bipolar Disorder Depressive Disorder Anxiety Disorders Psychotic Episode Schizoaffective Disorder

Focus group no.1 : Inclustion Criteria- * Hospitalized by consent in the psychiatric wards at the Sheba Medical Center. * Signed informed consent to participate in the study. Exclusion Criteria- * Patients with a low level of compliance to treatment. * Patients suffering from a significant active physical illness, intellectual disability, or complex organic conditions including dementia conditions * Patients who cannot read and write in the Hebrew language * Patients who are not qualified to give informed consent. Focus group no.2: Inclusion Criteria: * Staff members work in the inpatient wards and have a valid Israeli license. * Signed informed consent to participate in the study. No Exclusion Criteria. Focus group no.3- Inclustion Criteria: * Hospitalized by consent in the psychiatric wards at the Sheba Medical Center. * Signed informed consent to participate in the study. Exclusion Criteria: * Patients with a low level of compliance to treatment. * Patients suffering from a significant active physical illness, intellectual disability, or complex organic conditions including dementia conditions * Patients who cannot read and write in the Hebrew language * Patients who are not qualified to give informed consent. Monitoring model- The investigators will recruit 100 subjects hospitalized in the inpatient wards. Inclusion criteria: * Adults are consenting hospitalized in a psychiatric hospital at the Sheba Medical Center. * Staying in the open part of the ward. * Owns a mobile smartphone. Exclusion criteria: * Patients with a low level of treatment compliance. * Patients with a developmental or intellectual disability, complex organic conditions including dementia. * Patients who cannot read and write in the Hebrew language * Patients who are incapable of informed consent. The study inclusion criteria for the multi-disciplinary team: * Multi-disciplinary team members who work in the psychiatric inpatient wards at the Sheba Medical Center. * The staff members will have a valid Israeli license (from the professions of medicine, nursing, psychology, social work, and occupational therapy).

Locations (1)

Chaim Sheba Medical Center

Ramat Gan, Israel