The Use of ReMindCare Application for Smartphone in Treatment of Patients From First Episode of Psychosis Unit in the Clinic Hospital of Valencia, Spain.
试验速览
- 阶段
- 不适用
- 发起方
- INCLIVA
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Adherence to treatment
研究概览
简要总结
ReMindCare is an app designed by the Unit of Psychiatry at the Clinical Hospital of Valencia in liaison with the Polytechnic University of Valencia.
This e-Health app gathers information about the clinical health status of patients with Psychotic Disorder Diagnose through daily and weekly brief assessments.
This information is displayed in a restricted access website, where clinicians can visualize data from patients as well as download pdf reports of main data collected by the app. These reports can be attached to the electronic clinical report of the patient at the hospital database, being accessible for consultation for every clinician involved in treatment of the patient.
Furthermore, ReMindCare produces different alarms which notify clinicians about variations into patients health status or the cessation of using the app. Moreover, patients can also deliberately generate an urgent consultation alarm.
The introduction of ReMindCare app into clinical practice will follow a clinical trial structure in which treatment as usual (TAU) of patients from a First Episode of Psychosis Unit will be compared to ReMindCare app intervention program. After participants eligible for inclusion complete baseline assessments they will be randomly allocated to one of the two groups (Intervention or TAU) by a basic single blind randomization in which an independent researcher will perform the allocation using a computerized random number generator.
Information collected through the app and variations into clinical data will be analyzed among time. First assessment of these data will be conducted after 6 months of patient´s enrollment into the study. Subsequent analysis will be conducted yearly.
详细描述
Baseline surveys:
Baseline surveys will be administered. In this first evaluation, sociodemographic information and clinical information such as diagnosis, pattern of antipsychotic treatment, number of suicide attempts or associated illnesses will be collected.
Furthermore, some structured questionnaires will be administered, including: Clinical Global Impression Scale (CGI), Global Assessment of Functioning (GAF), Positive and Negative Syndrome Scale (PANSS), Premorbid Adjustment Scale (PAS), Simplified Medication Adherence Questionnaire (SMAQ), Drug Attitude Inventory (DAI-10) and Beck Cognitive Insight Scale (BCIS).
ReMindCare app measures:
Patients will generate the following data by using the app:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from the FEPU at Clinic Hospital of Valencia.
- •Diagnosis of Psychotic Disorder following DSMI-5 [32] criteria.
- •Age between 17 to 65 years old.
- •Owning a smartphone which allows the correct installation and functioning of the App.
- •Owning a smartphone which allows internet connection (not necessary permanent)
排除标准
- •Severe Mental Disability
- •Lack of abilities in using and mastering mobile devices and internet.
- •Not to sign informed consent sheet.
- •Level of Spanish not fluid.
- •Do not have an own smartphone.
研究组 & 干预措施
ReMindCare Intervention Group
Patients from First Episode of Psychosis Unit who will use ReMindCare app.
ReMindCare is an user-friendly app which conducts daily evaluations of the health status of patients with psychosis by some quick questions that patients will have to answer.
干预措施: ReMindCare Intervention Group (Device)
Treatment as Usual
Patients from First Episode of Psychosis Unit who will follow psychiatric usual care.
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Adherence to treatment
时间窗: Yearly, up to 2 years
Number of hospital admissions and urgent care visits
Early relapse detection
时间窗: Yearly, up to 2 years
Changes in detection of relapses into psychotic sympthoms. Measured by number of contacts to patients in response to alerts generated by the app.
Adherence to anti-psychotic treatment
时间窗: Yearly, up to 2 years
Adherence to anti-psychotic medication intake. Measured by: Simplified Medication Adherence Questionnaire (SMAQ).
次要结局
- Changes in comunication between clinicians(Yearly, up to 2 years)
- Feeling of empowerment related to illness self-management(Yearly, up to 2 years)
- Alliance between patient and clinician(Yearly, up to 2 years)
研究者
Lucia Bonet
Principal Investigator
University of Valencia
