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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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.

• 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.

Locations
Other Locations
Israel
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Contact Information
Primary
Hilla Mordechai, MA
hillamor1@gmail.com
+972507863471
Backup
Mark Weiser, MD
mweiser@netvision.net.il
+97235303773
Time Frame
Start Date: 2022-05-18
Estimated Completion Date: 2024-10-18
Participants
Target number of participants: 130
Related Therapeutic Areas
Sponsors
Leads: Sheba Medical Center

This content was sourced from clinicaltrials.gov