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

NCT06182787 | Recruiting

• 1 other identifier: SHEBA-21-8403-MW-CTIL
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ESM; EMA; Psychiatry; Inpatients; Hospitalization; PANSS; Validity; Digital Monitoring; Mental State; Smartwatch; Development; Feasibility; Compliance

Outcome Measures

Primary Outcomes (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.

  The positive and negative syndrome scale (PANSS) for schizophrenia is measuring the severity of symptoms in patients with schizophrenia spectrum disorders. It is conducted through a brief interview rather than a self-report. The ESM (Experience Sampling Method) is a method Structured based on a diary, in which the subjects are asked to report their thoughts, feelings, and symptoms during their daily life, as well as to describe the context in which the report takes place. The validation of the ESM questionnaire will be conducted by comparing the change trends in the questionnaire indices during a 14-day psychiatric hospitalization period to the change trends in four different measurements of psychiatric symptoms assessed by the PANSS diagnostic tool, which is widely recognized as the gold standard in psychiatric symptom assessment. The subject's assessment using PANSS will be conducted at three different time points.

  14 days.

Secondary Outcomes (1)

• Development of the monitoring questionnaire - Content validity phase.

  14 days

Other Outcomes (8)

• Investigation of the feasibility and compliance of patients in responding to self-report questionnaires.

  14 days

• Investigation of the feasibility of patients in participating in the study.

  14 days

• Investigation of the feasibility and compliance of patients with different diagnoses in participating in the study.

  14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Focus group No. 1: The first focus group included patients hospitalized in the psychiatric ward. Recruited nine subjects over age 18 (6 women and three men). Focus group No. 2: The second focus group includes a multi-disciplinary team working in the psychiatric inpatient wards. Recruited seven staff members working in the psychiatric hospitalization wards in Sheba Medical Center (3 women and four men), participated in the focus group. Focus group No.3: The third focus group included hospitalized inpatients for cognitive debriefing. Recruited six subjects over 18 (two women and four men). To conduct the monitoring model, we will recruit 100 subjects hospitalized in the inpatient wards. To receive feedback on implementing the monitoring model from the multi-disciplinary care team working in the wards, we will recruit 30 multi-disciplinary team members.

You may not qualify if:

• 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:
• Staff members work in the inpatient wards and have a valid Israeli license.
• Signed informed consent to participate in the study.
• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (9)

• 1. Derogatis, L. R. (1992). SCL-90-R: Administration, scoring and procedures manual for the R(evised) version and other instruments of the psychopathology rating scale series.

  BACKGROUND

• 2. Hektner, J. M., Schmidt, J. A., & Csikszentmihalyi, M. (2007). Experience sampling method: Measuring the quality of everyday life. Sage.

  BACKGROUND

• Myin-Germeys I, Oorschot M, Collip D, Lataster J, Delespaul P, van Os J. Experience sampling research in psychopathology: opening the black box of daily life. Psychol Med. 2009 Sep;39(9):1533-47. doi: 10.1017/S0033291708004947. Epub 2009 Feb 12.

  PMID: 19215626 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.

  PMID: 21697139 BACKGROUND

• 6. Kroenke, K., & Spitzer, R. L. (2002). The PHQ-9: a new depression diagnostic and severity measure. Psychiatric annals, 32(9), 509-515.

  BACKGROUND

• 7. Stone, A., Shiffman, S., Atienza, A., & Nebeling, L. (2007). The science of real-time data capture: Self-reports in health research. Oxford University Press.

  BACKGROUND

• Johnson EI, Grondin O, Barrault M, Faytout M, Helbig S, Husky M, Granholm EL, Loh C, Nadeau L, Wittchen HU, Swendsen J. Computerized ambulatory monitoring in psychiatry: a multi-site collaborative study of acceptability, compliance, and reactivity. Int J Methods Psychiatr Res. 2009;18(1):48-57. doi: 10.1002/mpr.276.

  PMID: 19195050 BACKGROUND

• Verhagen SJ, Hasmi L, Drukker M, van Os J, Delespaul PA. Use of the experience sampling method in the context of clinical trials. Evid Based Ment Health. 2016 Aug;19(3):86-9. doi: 10.1136/ebmental-2016-102418.

  PMID: 27443678 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Personality Disorders; Mood Disorders; Bipolar Disorder; Depressive Disorder; Anxiety Disorders; Psychotic Disorders; Patient Compliance

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Hilla Mordechai, MA

CONTACT

+972507863471; hillamor1@gmail.com

Mark Weiser, MD

CONTACT

+97235303773; mweiser@netvision.net.il

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: December 27, 2023
• Study Start: May 18, 2022
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-05

Locations

IL (1)