Digital monitoring of mental state in hospitalized patients
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
This study is testing a new digital questionnaire and smartwatch sensors to see if they can help track the mental state of patients in the hospital more effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT06182787 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing and validating a Digital Experience Sampling Method (ESM) questionnaire tailored for monitoring the mental state of patients during psychiatric hospitalization. It involves collecting data from 100 subjects over a 14-day period, where symptom severity trends from the ESM questionnaire will be compared with assessments from the Positive and Negative Syndrome Scale (PANSS). Additionally, smartwatch sensors will be used to monitor physiological indicators, and patient compliance with the digital tools will be evaluated. The study aims to ensure that the questionnaire is relevant and applicable to the unique characteristics of mental state changes in hospitalized patients.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients at Sheba Medical Center who can provide informed consent and are experiencing severe mental disorders.
Not a fit: Patients with low treatment compliance, significant active physical illnesses, or those unable to read and write in Hebrew may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the monitoring and management of mental health conditions in hospitalized patients, leading to improved treatment outcomes.
How similar studies have performed: While the specific approach of using a digital ESM questionnaire in this context may be novel, similar methodologies have shown promise in other studies focused on mental health monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Ramat Gan
- Chaim Sheba Medical Center — Ramat Gan, Israel (Recruiting)
Study contacts
- Study coordinator: Hilla Mordechai, MA
- Email: hillamor1@gmail.com
- Phone: +972507863471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.