Schizophrenia Clinical Trial
Official title:
The Use of ReMindCare Application for Smartphone in Treatment of Patients From First Episode of Psychosis Unit in the Clinic Hospital of Valencia, Spain.
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.
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:
1. Data generated through responses to daily and weekly app questionnaires: Answers to
these questionnaires are presented following a Likert scale (1 to 5) as follows: 1=Not
at all, 2=Slightly, 3=Somewhat, 4=Very, 5=Extremely. Responses will be collected and
analyzed.
2. Quantity of "Urgent clinic consultation" request made for every patient.
3. Quantity of automatic usage alarms.
Treatment measures:
Apart from data collected through the use of the app, further information will be collected
related to modifications into de patient´s treatment or related to his/her health status:
- Modifications into antipsychotic treatment.
- Number of relapses
- Number of visits to hospital urgent care unit.
- Number of hospital admissions
Follow-up measures and satisfaction questionnaire:
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.
Patients will also complete a satisfaction questionnaire after one year using the ReMindCare
app or before discontinuing the use the app (if this happens before the first year of use of
the app has come). This app feedback questionnaire is made for the purpose of this research
and it is based in some previous satisfaction and usability questionnaires such as: User
Version of the mobile application rating scale (uMars), System Usability Scale (SUS),
EnLight: Tool for mobile and web-based eHealth interventions and App Quality Evaluation
(AQEL).
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