Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient (NCT06182787) | Clinical Trial Compass
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Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient
Israel130 participantsStarted 2022-05-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary objective of this study is to validate the ESM questionnaire by comparing the trends in symptom severity as reported through the ESM questionnaire with the PANSS assessment of symptom severity.