Clinical trial NCT03807388: ReMindCare App for Patients From First Episode of Psychosis Unit.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Schizophrenia
Psychotic Disorders
Delirium
Hallucinations
Adherence, Medication
Treatment Side Effects
Keywords: eHealth
mHealth
smartphone
app
psychosis
adherence
early intervention
Lead sponsor: INCLIVA
Sponsor class: INDUSTRY
Collaborators: name: Instituto de Investigacion Sanitaria INCLIVA
name: University of Valencia
name: Universitat Politècnica de València
name: Hospital Clínico Universitario de Valencia
First posted: 2019-01-16
Enrollment: 140
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adherence to anti-psychotic treatment
timeFrame: Yearly, up to 2 years
measure: Adherence to treatment
timeFrame: Yearly, up to 2 years
measure: Early relapse detection
timeFrame: Yearly, up to 2 years
Secondary outcomes:
measure: Alliance between patient and clinician
timeFrame: Yearly, up to 2 years
measure: Feeling of empowerment related to illness self-management
timeFrame: Yearly, up to 2 years
measure: Changes in comunication between clinicians
timeFrame: Yearly, up to 2 years
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: INCLIVA
Study officials:
affiliation: INCLIVA
name: Julio Sanjuán
role: STUDY_DIRECTOR
References:
citation: Bonet L, Izquierdo C, Escarti MJ, Sancho JV, Arce D, Blanquer I, Sanjuan J. Use of mobile technologies in patients with psychosis: A systematic review. Rev Psiquiatr Salud Ment. 2017 Jul-Sep;10(3):168-178. doi: 10.1016/j.rpsm.2017.01.003. Epub 2017 Mar 1. English, Spanish.
citation: Bonet L, Llacer B, Hernandez-Viadel M, Arce D, Blanquer I, Canete C, Escarti M, Gonzalez-Pinto AM, Sanjuan J. Differences in the Use and Opinions About New eHealth Technologies Among Patients With Psychosis: Structured Questionnaire. JMIR Ment Health. 2018 Jul 25;5(3):e51. doi: 10.2196/mental.9950.