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ReMindCare App for Patients From First Episode of Psychosis Unit.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807388
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
Instituto de Investigacion Sanitaria INCLIVA
University of Valencia
Universitat Politècnica de València
Hospital Clínico Universitario de Valencia
Information provided by (Responsible Party):
Lucia Bonet, University of Valencia

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.


Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Psychotic Disorders Delirium Hallucinations Adherence, Medication Treatment Side Effects Device: ReMindCare Intervention Group Other: Treatment as Usual Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ReMindCare Intervention Group

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
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 Name: ReMindCare app

Treatment as Usual
Patients from First Episode of Psychosis Unit who will follow psychiatric usual care.
Other: Treatment as Usual
Psychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain.




Primary Outcome Measures :
  1. Adherence to anti-psychotic treatment [ Time Frame: Yearly, up to 2 years ]
    Adherence to anti-psychotic medication intake. Measured by: Simplified Medication Adherence Questionnaire (SMAQ).

  2. Adherence to treatment [ Time Frame: Yearly, up to 2 years ]
    Number of hospital admissions and urgent care visits

  3. Early relapse detection [ Time Frame: Yearly, up to 2 years ]
    Changes in detection of relapses into psychotic sympthoms. Measured by number of contacts to patients in response to alerts generated by the app.


Secondary Outcome Measures :
  1. Alliance between patient and clinician [ Time Frame: Yearly, up to 2 years ]
    Changes in feelings of alliance between patient and clinician. Measured by a Satisfaction Questionnaire, made for the purpose of this research.

  2. Feeling of empowerment related to illness self-management [ Time Frame: Yearly, up to 2 years ]
    Changes in patient´s feelings of empowerment related to illness self-management. Measured by a Satisfaction Questionnaire, made for the purpose of this research.

  3. Changes in comunication between clinicians [ Time Frame: Yearly, up to 2 years ]
    Study of changes related to comunication between clinicians about treatment of patients. Measured qualitatively by a focus group session.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807388


Contacts
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Contact: Lucia Bonet, PhD +34 600745550 lbonetm@gmail.com

Locations
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Spain
INCLIVA
Valencia, Spain, 46010
Contact: Marta Peiró         
Sponsors and Collaborators
INCLIVA
Instituto de Investigacion Sanitaria INCLIVA
University of Valencia
Universitat Politècnica de València
Hospital Clínico Universitario de Valencia
Investigators
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Study Director: Julio Sanjuán INCLIVA
Publications:
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Responsible Party: Lucia Bonet, Principal Investigator, University of Valencia
ClinicalTrials.gov Identifier: NCT03807388    
Other Study ID Numbers: 2018/059
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

We plan to share the following IPD data. However they will be analyzed as a group:

Responses to the following questionnaires:

  • Clinical Global Impression Scale (CGI)
  • Global Assessment of Functioning (GAF)
  • Positive and Negative Syndrome Scale (PANSS)
  • Simplified Medication Adherence Questionnaire (SMAQ)
  • Drug Attitude Inventory (DAI-10)
  • Beck Cognitive Insight Scale (BCIS)

Socio-demographics information such as: Age, gender, ethnicity education, marital status, living situation.

Answers of patient to ReMindCare app assessments: Daily / weekly responses and alarms generated

Treatment related measures:

  • Modifications into antipsychotic treatment.
  • Number of relapses
  • Number of visits to hospital urgent care unit.
  • Number of hospital admissions
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data has been sent for publication in an open access journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lucia Bonet, University of Valencia:
eHealth
mHealth
smartphone
app
psychosis
adherence
early intervention
Additional relevant MeSH terms:
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Hallucinations
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Perceptual Disorders