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

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

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

Inclusion Criteria10

Focus group no.1 :
Inclustion Criteria-
Hospitalized by consent in the psychiatric wards at the Sheba Medical Center.
Staff members work in the inpatient wards and have a valid Israeli license.
Signed informed consent to participate in the study.
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.
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).

Exclusion Criteria18

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:
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.
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.
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.