ReMindCare App for Patients From First Episode of Psychosis Unit.

NCT03807388 | Unknown DMC

• 1 other identifier: 2018/059
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Adherence to anti-psychotic treatment

  Adherence to anti-psychotic medication intake. Measured by: Simplified Medication Adherence Questionnaire (SMAQ).

  Yearly, up to 2 years

• Adherence to treatment

  Number of hospital admissions and urgent care visits

  Yearly, up to 2 years

• 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 Outcomes (3)

• Alliance between patient and clinician

  Yearly, up to 2 years

• Feeling of empowerment related to illness self-management

  Yearly, up to 2 years

• Changes in comunication between clinicians

  Yearly, up to 2 years

Study Arms (2)

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.

Device: ReMindCare Intervention Group

Treatment as Usual

OTHER

Patients from First Episode of Psychosis Unit who will follow psychiatric usual care.

Other: Treatment as Usual

Interventions

ReMindCare Intervention Group DEVICE

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.

Also known as: ReMindCare app

ReMindCare Intervention Group

Treatment as Usual OTHER

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

Treatment as Usual

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria INCLIVA: lead
• University of Valencia: collaborator
• Universitat Politècnica de València: collaborator
• Hospital Clínico Universitario de Valencia: collaborator

Study Sites (1)

INCLIVA

Valencia, 46010, Spain

Location

Related Publications (2)

• 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.

  PMID: 28258835 BACKGROUND

• 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.

  PMID: 30045835 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Delirium; Hallucinations; Medication Adherence; Alzheimer Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Perceptual Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Julio Sanjuán

  Instituto de Investigacion Sanitaria INCLIVA

  STUDY DIRECTOR

Central Study Contacts

Lucia Bonet, PhD

CONTACT

+34 600745550; lbonetm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 16, 2019
• Study Start: September 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2023
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data has been sent for publication in an open access journal.

Locations

ES (1)