ReMindCare App for Patients From First Episode of Psychosis Unit.
NCT03807388 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2019-01-16
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
Interventions
- 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.
Sponsors & Collaborators
-
University of Valencia
collaborator OTHER -
Universitat Politècnica de València
collaborator OTHER -
Hospital Clínico Universitario de Valencia
collaborator OTHER -
Instituto de Investigacion Sanitaria INCLIVA
lead INDUSTRY
Principal Investigators
-
Julio Sanjuán · Instituto de Investigacion Sanitaria INCLIVA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 17 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-30
- Primary Completion
- 2020-05-31
- Completion
- 2023-09-30
Countries
- Spain
Study Locations
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