Decision Support System for Stroke Survivors

Study Overview
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Brief Summary
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The aim of the study is to evaluate the usability of the system and its accordance with the users' needs. This evaluation will consider the effectiveness and the efficiency of the system, as well as stroke survivors' satisfaction. The effectiveness and the efficiency of the system will be measured by: The relationship between the control of stroke survivors' daily activities and their risk of having a secondary stroke, The decrease of the need for caregivers, And consequently an improvement in stroke survivors' self-management.

Detailed Description
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The aim of the study is to evaluate the usability of the system and its accordance with the users' needs. This evaluation will consider the effectiveness and the efficiency of the system, as well as stroke survivors' satisfaction.

Official Title
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Efficacy and Usability of eHealth Technologies in Stroke Survivors for Prevention of a New Stroke and Improvement of Self-management: Phase III Randomized Control Trial

Conditions
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Stroke, Telerehabilitation, Life Style

Intervention / Treatment
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* Device: eHealth Technologies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 80 years. First ischemic stroke within the past 6 months. Hemiparesia with mild (91-99)-moderate (61-90) disability (Barthel Index). With or without speech patology but able to understand simple orders ( >45). Able to cope and to understand the guidelines to use the devices. Informed consent signed. Exclusion Criteria: Life expectancy <12 months. Severe cognitive impairments. Medical comorbidities that could interfere with the home-rehabilitation program (MoCA < 26). Socio-familiar dystocia (SFES ≥ 14). Modified Rankin Scale > 1.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will perform a randomised, pilot, prospective, parallel group, open, and unicentric Clinical Trial (RCT) with stroke survivors and their caregivers at Cruces University Hospital.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth Technologies<br>eHealth Technologies is a messure of diferent paramenters of the patient; heart rate, blood pressure, weight, thermometer, daily activity. | Device: eHealth Technologies<br>* The controls will get a conventional treatment from the acute to the chronic phase of stroke and the cases will get a conventional treatment till the end of the subacute phase. However, in the chronic period they will use the developed STARR App and DSS, as well as commercial wearables.<br>|
| No Intervention: Control<br>Habitual treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale | The System Usability Scale (SUS) provides a quick and dirty, reliable tool for measuring the usability. Developers work to create systems that are easy and straight-forward for people to use. Terms such as user friendly and easy-to-use often indicate these characteristics, but the overall technical name for them is usability. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | This an outcome to evaluate the eligibility of the patient. Age variable will be in years. | 12 months | 
| Stroke date | This an outcome to evaluate the eligibility of the patient. This variable will be the patient stroke date. | 12 months | 
| Oxfordshire Community Stroke Project Classification | This an outcome to evaluate the eligibility of the patient. This variable will be useful in estimation of after stroke complications and prognostication. | 12 months | 
| Modified Barthel Index | This an outcome to evaluate the eligibility of the patient. This variable will assessing self care and mobility activities of daily living of the patient. | 12 months | 
| Mississippi Aphasia Screening Test | This an outcome to evaluate the eligibility of the patient. This variable will to be used to detect changes in language abilities over time of the patient. | 12 months | 
| Montreal Cognitive Assessment | This an outcome to evaluate the eligibility of the patient. This variable will be collected for detecting cognitive impairment of the patient. | 12 months | 
| Gijon's social-familial evaluation Scale | Assess the social and family situation of people living in the home. Detect risk situations and social problems. There are no subscales. It has a global score. Score between 0-20 points, indicating higher score worse social situation. | 12 months | 
| Charlson Comorbidity Index | This an outcome to evaluate the eligibility of the patient. | 12 months | 
| Gender | This is a socio demographic outcome. This outcome will be collected as Male or Female. | 12 months | 
| Ethnic group | This is a socio demographic outcome. | 12 months | 
| Deprivation index | This is a socio demographic outcome. | 12 months | 
| Hand dominance | This is a socio demographic outcome. This outcome will be collected as right-handed and left-handed. | 12 months | 
| Education level | This is a socio demographic outcome. | 12 months | 
| Type of profession | This is a socio demographic outcome. | 12 months | 
| Hobbies | This is a socio demographic outcome. | 12 months | 
| Medical Research Council Scale | Scale for testing muscle strength in palsy. There are no subscales. It measures from Grade 0 (No contraction) to Grade 5 (Normal strength). | 12 months | 
| MAST Test | This is a neurological physical examination. | 12 months | 
| MoCA Test | This is a neurological physical examination. | 12 months | 
| Functional Ambulation Categories | This is a neurological physical examination. | 12 months | 
| 10 Meters Walking Test | This is a neurological physical examination. The variable will collected in m/sg. | 12 months | 
| 6 Minutes Walking Test | This is a neurological physical examination. The variable will collected in metres. | 12 months | 
| Berg Balance Scale | This is a neurological physical examination. | 12 months | 
| Frenchay Arm Test | This is a neurological physical examination. | 12 months | 
| Asworth Modified Scale | Scale for testing muscle spasticity. It rates severity of tone. There are no subscales. It measures from Grade 0 (No increase in muscle tone) to Grade 4 (Affected part(s) rigid in flexion or extension). | 12 months | 
| Fatigue Severity Scale | To measure the fatigue caused by a number of chronic medical conditions. There are no subscales. It has a global score. The FSS questionnaire contains nine statements. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. The total mean score is 7 points. FSS mean score > 4 indicates severe fatigue. | 12 months | 
| Line Bisection Test | This is a neurological physical examination. | 12 months | 
| Disphagia | This is a neurological physical examination. | 12 months | 
| Campimetry | This is a neurological physical examination. | 12 months | 
| Analogic Visual Scale | This is a neurological physical examination. | 12 months | 
| Analgesic Treatments | This is a neurological physical examination. | 12 months | 
| Golberg Scale | This is a cardiovascular risk factor. To messure depression and anxiety. | 12 months | 
| Weight | This is a cardiovascular risk factor. In kg | 12 months | 
| Height | This is a cardiovascular risk factor. In meter | 12 months | 
| BMI | This is a cardiovascular risk factor. | 12 months | 
| Waist Size | This is a cardiovascular risk factor. | 12 months | 
| Waist to Hip Ratio | This is a cardiovascular risk factor. | 12 months | 
| Blood Pressure | This is a cardiovascular risk factor. In mmHg | 12 months | 
| Heart Rate | This is a cardiovascular risk factor. | 12 months | 
| Glycaemia | This is a cardiovascular risk factor. | 12 months | 
| Health Literacy Test | This is for measure the health literacy of the patient. | 12 months | 
| Mediterranean Diet Assessment Test | This is for measure the life style of the patient. | 12 months | 
| Physical Activity | This is for measure the life style of the patient. | 12 months | 
| Toxic Consumption | This is for measure the life style of the patient. | 12 months | 
| Total Cholesterol | This is a blood test for measure the lipidic profile of the patient. | 12 months | 
| HDL | This is a blood test for measure the lipidic profile of the patient. | 12 months | 
| LDL | This is a blood test for measure the lipidic profile of the patient. | 12 months | 
| Proteins | This is a blood test of the patient. | 12 months | 
| Albumin | This is a blood test of the patient. | 12 months | 
| HbA1c | This is a blood test of the patient. | 12 months | 
| Apoprotein B | This is a blood test of the patient. | 12 months | 
| Apoportein A1 | This is a blood test of the patient. | 12 months | 
| Lawton Index | This is to messure the activities of daily living of the patient. | 12 months | 
| SF-36 | This is to messure the quality of life of the patient. | 12 months | 
| SIS | This is to messure the quality of life of the patient. | 12 months | 
| Stroke Self Management Questionary | This is to messure the self management satisfaction of the patient. | 12 months | 
| Stroke Management Questionary | This is to messure the self management satisfaction of the patient. | 12 months | 
| Satisfaction Questionary | This is to messure the self management satisfaction of the patient. | 12 months | 
| Post Stroke Checklist | This is to messure the adherence to the treatment of the patient. | 12 months | 
| Pharmacological Accountability | This is to messure the adherence to the treatment of the patient. | 12 months | 
| Non Pharmacological Accountability | This is to messure the adherence to the treatment of the patient. | 12 months | 
| Stroke Recurrences | This is to messure the complications of the patient. | 12 months | 
| Number of Readmissions | This is to messure the complications of the patient. | 12 months |