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ReMindCare App for Patients From First Episode of Psychosis Unit.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03807388
Enrollment
140
Registered
2019-01-16
Start date
2019-09-30
Completion date
2023-09-30
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

eHealth, mHealth, smartphone, app, psychosis, adherence, early intervention

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).

Interventions

DEVICEReMindCare 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.

OTHERTreatment as Usual

Psychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain.

Sponsors

University of Valencia
CollaboratorOTHER
Universitat Politècnica de València
CollaboratorOTHER
Hospital Clínico Universitario de Valencia
CollaboratorOTHER
Instituto de Investigacion Sanitaria INCLIVA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adherence to anti-psychotic treatmentYearly, up to 2 yearsAdherence to anti-psychotic medication intake. Measured by: Simplified Medication Adherence Questionnaire (SMAQ).
Adherence to treatmentYearly, up to 2 yearsNumber of hospital admissions and urgent care visits
Early relapse detectionYearly, up to 2 yearsChanges in detection of relapses into psychotic sympthoms. Measured by number of contacts to patients in response to alerts generated by the app.

Secondary

MeasureTime frameDescription
Alliance between patient and clinicianYearly, up to 2 yearsChanges in feelings of alliance between patient and clinician. Measured by a Satisfaction Questionnaire, made for the purpose of this research.
Feeling of empowerment related to illness self-managementYearly, up to 2 yearsChanges in patient´s feelings of empowerment related to illness self-management. Measured by a Satisfaction Questionnaire, made for the purpose of this research.
Changes in comunication between cliniciansYearly, up to 2 yearsStudy of changes related to comunication between clinicians about treatment of patients. Measured qualitatively by a focus group session.

Countries

Spain

Contacts

Primary ContactLucia Bonet, PhD
lbonetm@gmail.com+34 600745550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026