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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
The research will be carried out in two phases:
-
Development of the monitoring questionnaire - Content validity phase - This phase has been fully completed, and its results will be presented in the preliminary results chapter. At this research stage, the core content domains of the monitoring questionnaire will be developed. The research process in this phase includes the following:
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Examining the content of scales from the Positive and Negative Syndrome Scale (PANSS) for schizophrenia and The Symptom Checklist-90-R (SCL-90-R) questionnaire: At this stage, the psychiatric symptoms and the main criteria for assessing a mental state as emerged from those questionnaires were examined for discussion in the focus groups.
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Focus group No. 1: The first focus group included patients hospitalized in the psychiatric ward. The purpose of the focus group is to formulate the ESM core and additional content domains and the questionnaire items and to discuss the optimal measurement frequency according to the hospitalized patients' opinions. The focus group will also examine the wording that best suits how the patients describe their mental state.
Indices The subjects' point of view regarding the psychiatric symptoms they suffered from during their hospitalization was examined during a free discussion. Emphasis was placed on the symptoms that change daily throughout the hospitalization and how much they indicate a change in their mental state. The investigators also investigated what information they would like to report to the treatment team about their mental state throughout the hospitalization. After the free discussion, the position of the subjects was examined regarding the criteria for assessing mental state as they emerged from the monitoring scales of the PROM questionnaires.
After a qualitative analysis of the information collected at this stage, the main themes of the ESM questionnaire were formulated. According to the themes found, suggestions were developed for the questionnaire items while noting how the patient's symptoms were worded. A professional transcriber transcribed the discussion. 3. Focus group No. 2: The second focus group includes a multi-disciplinary team working in the psychiatric inpatient wards. In a free discussion, the multi-disciplinary team members examined the core issues that should appear in the questionnaire for monitoring the mental state of hospitalized patients, then explored and expressed their opinion regarding the issues raised by the patients in the first focus group. The result of this step will be an ESM questionnaire adapted to the needs of the patients and the clinical staff in the inpatient wards.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
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.
时间窗: 14 days.
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.
次要结局
- Development of the monitoring questionnaire - Content validity phase.(14 days)