PsychosisNCT03807388
ReMindCare App for Patients From First Episode of Psychosis Unit.
A study testing ReMindCare Intervention Group and Treatment as Usual in people with Psychosis and Schizophrenia, run by Instituto de Investigacion Sanitaria INCLIVA at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Psychosis, Schizophrenia, Psychotic Disorders
- What is being tested?
- ReMindCare Intervention Group and Treatment as Usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2019to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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:
- 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.
- Quantity of "Urgent clinic consultation" request made for every patient.
- 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).
- Conditions
- Psychosis, Schizophrenia, Psychotic Disorders, Delirium, Hallucinations, Adherence, Medication
- Being tested
- ReMindCare Intervention Group, Treatment as Usual
- Keywords
- eHealth, mHealth, smartphone, app, psychosis, adherence, early intervention
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Delirium, Hallucinations, Medication Adherence, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReMindCare Intervention GroupDevice
Also called ReMindCare app
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.
Treatment as UsualOther
Psychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ReMindCare Intervention Group |
| Treatment as Usual | Other | Patients from First Episode of Psychosis Unit who will follow psychiatric usual care. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to anti-psychotic treatment
Adherence to anti-psychotic medication intake. Measured by: Simplified Medication Adherence Questionnaire (SMAQ).
Measured: Yearly, up to 2 years
Adherence to treatment
Number of hospital admissions and urgent care visits
Measured: 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.
Measured: Yearly, up to 2 years
Secondary outcomes (3)
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.
Measured: Yearly, up to 2 years
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.
Measured: Yearly, up to 2 years
Changes in comunication between clinicians
Study of changes related to comunication between clinicians about treatment of patients. Measured qualitatively by a focus group session.
Measured: Yearly, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study startSep 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria INCLIVA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia, Universitat Politècnica de València, Hospital Clínico Universitario de Valencia
- Responsible party
- Principal investigator, Lucia Bonet, University of Valencia
- Investigators
- Julio Sanjuán, Study director, Instituto de Investigacion Sanitaria INCLIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807388
- Sponsor's protocol ID
- 2018/059
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 28258835Bonet 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.
PubMed 30045835
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03807388
- Acronym / sponsor ID
- 2018/059
- Conditions
- Psychosis, Schizophrenia, Psychotic Disorders, Delirium, Hallucinations, Adherence, Medication
- Keywords
- eHealth, mHealth, smartphone, app, psychosis, adherence, early intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria INCLIVAUniversity, hospital or other
- Collaborators
- University of Valencia, Universitat Politècnica de València, Hospital Clínico Universitario de Valencia
- Study start
- Sep 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Quantity of "Urgent clinic consultation" request made for every patient.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReMindCare Intervention Group | Experimental | Device: ReMindCare Intervention GroupPatients 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. |
| Treatment as Usual | Other | Other: Treatment as UsualPatients from First Episode of Psychosis Unit who will follow psychiatric usual care. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReMindCare Intervention GroupAlso: ReMindCare appDaily 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. | Device | ReMindCare Intervention Group |
| Treatment as UsualPsychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain. | Other | Treatment as Usual |
Primary outcome
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).
Adherence to treatment
Time frame: Yearly, up to 2 years
Number of hospital admissions and urgent care visits
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.
3 secondary outcomes
Alliance between patient and clinician
Time frame: Yearly, up to 2 years
Feeling of empowerment related to illness self-management
Time frame: Yearly, up to 2 years
Changes in comunication between clinicians
Time frame: Yearly, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Background: PubMed 28258835Bonet 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.
- Background: PubMed 30045835Bonet 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.
- Individual participant dataSharing planned: Yes. 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
Related trials for Psychosis
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Sanjuán study director
Instituto de Investigacion Sanitaria INCLIVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReMindCare Intervention Group and Treatment as Usual in people with Psychosis and Schizophrenia, run by Instituto de Investigacion Sanitaria INCLIVA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia Bonet, PhD (+34 600745550, lbonetm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to anti-psychotic treatment (time frame: Yearly, up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03807388, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.