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| Name | Class |
|---|---|
| University of Valencia | OTHER |
| Universitat Politècnica de València | OTHER |
| Hospital ClĂnico Universitario de Valencia | OTHER |
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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.
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:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Treatment as Usual | Other | Patients from First Episode of Psychosis Unit who will follow psychiatric usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Yearly, up to 2 years |
| Feeling of empowerment related to illness self-management |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Bonet, PhD | Contact | +34 600745550 | lbonetm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Julio SanjuĂ¡n | Instituto de Investigacion Sanitaria INCLIVA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INCLIVA | Valencia | 46010 | Spain |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28258835 | Background | 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. | |
| 30045835 | 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. |
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We plan to share the following IPD data. However they will be analyzed as a group:
Responses to the following questionnaires:
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:
The data has been sent for publication in an open access journal.
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D003693 | Delirium |
| D006212 | Hallucinations |
| D055118 | Medication Adherence |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Treatment as Usual | Other | Psychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain. |
|
Changes in patient´s feelings of empowerment related to illness self-management. Measured by a Satisfaction Questionnaire, made for the purpose of this research. |
| 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. | Yearly, up to 2 years |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D010468 | Perceptual Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |