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临床试验/NCT03807388
NCT03807388Unknown不适用

The Use of ReMindCare Application for Smartphone in Treatment of Patients From First Episode of Psychosis Unit in the Clinic Hospital of Valencia, Spain.

INCLIVA2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年9月最近更新:
适应症
干预措施

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

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

Experimental

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

Other

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

发起方
INCLIVA
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Lucia Bonet

Principal Investigator

University of Valencia

研究点 (2)

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