ReMindCare App for Patients From First Episode of Psychosis Unit.

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03807388
• Other study ID #: 2018/059
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: September 2023

Study information

• Verified date: January 2019
• Source: INCLIVA
• Contact: Lucia Bonet, PhD
• Phone: +34 600745550
• Email: lbonetm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 2023
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Medication
• Delirium
• Hallucinations
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia
• Treatment Side Effects

Intervention

Device:
• ReMindCare Intervention Group
Daily and weekly assessments of patient´s health status, and generation of alarms related to these answers. Moreover, patients can contact clinicians by an urgent consultation tab.

Other:
• Treatment as Usual
Psychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain.

Locations

Country	Name	City	State
Spain	INCLIVA	Valencia

Sponsors (5)

Lead Sponsor	Collaborator
INCLIVA	Hospital Clínico Universitario de Valencia, Instituto de Investigacion Sanitaria INCLIVA, Universitat Politècnica de València, University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Bonet L, Izquierdo C, Escartí 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. Review. English, Spanish. — View Citation

Bonet L, Llácer B, Hernandez-Viadel M, Arce D, Blanquer I, Cañete C, Escartí M, González-Pinto AM, Sanjuán 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to anti-psychotic treatment	Adherence to anti-psychotic medication intake. Measured by: Simplified Medication Adherence Questionnaire (SMAQ).	Yearly, up to 2 years
Primary	Adherence to treatment	Number of hospital admissions and urgent care visits	Yearly, up to 2 years
Primary	Early relapse detection	Changes in detection of relapses into psychotic sympthoms. Measured by number of contacts to patients in response to alerts generated by the app.	Yearly, up to 2 years
Secondary	Alliance between patient and clinician	Changes in feelings of alliance between patient and clinician. Measured by a Satisfaction Questionnaire, made for the purpose of this research.	Yearly, up to 2 years
Secondary	Feeling of empowerment related to illness self-management	Changes in patient´s feelings of empowerment related to illness self-management. Measured by a Satisfaction Questionnaire, made for the purpose of this research.	Yearly, up to 2 years
Secondary	Changes in comunication between clinicians	Study of changes related to comunication between clinicians about treatment of patients. Measured qualitatively by a focus group session.	Yearly, up to 2 years