Decision Support System for Stroke Survivors
- Conditions
- StrokeTelerehabilitationLife Style
- Interventions
- Device: eHealth Technologies
- Registration Number
- NCT03580642
- Lead Sponsor
- Biocruces Bizkaia Health Research Institute
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description eHealth Technologies eHealth Technologies eHealth Technologies is a messure of diferent paramenters of the patient; heart rate, blood pressure, weight, thermometer, daily activity.
- Primary Outcome Measures
Name Time Method System Usability Scale 12 months 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.
- Secondary Outcome Measures
Name Time Method Golberg Scale 12 months This is a cardiovascular risk factor. To messure depression and anxiety.
Weight 12 months This is a cardiovascular risk factor. In kg
Albumin 12 months This is a blood test of the patient.
Number of Readmissions 12 months This is to messure the complications of the patient.
Physical Activity 12 months This is for measure the life style of the patient.
Health Literacy Test 12 months This is for measure the health literacy of the patient.
Age 12 months This an outcome to evaluate the eligibility of the patient. Age variable will be in years.
Oxfordshire Community Stroke Project Classification 12 months This an outcome to evaluate the eligibility of the patient. This variable will be useful in estimation of after stroke complications and prognostication.
Gijon's social-familial evaluation Scale 12 months 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.Ethnic group 12 months This is a socio demographic outcome.
Type of profession 12 months This is a socio demographic outcome.
MAST Test 12 months This is a neurological physical examination.
Functional Ambulation Categories 12 months This is a neurological physical examination.
6 Minutes Walking Test 12 months This is a neurological physical examination. The variable will collected in metres.
Disphagia 12 months This is a neurological physical examination.
Stroke date 12 months This an outcome to evaluate the eligibility of the patient. This variable will be the patient stroke date.
Modified Barthel Index 12 months 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.
Mississippi Aphasia Screening Test 12 months 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.
Montreal Cognitive Assessment 12 months This an outcome to evaluate the eligibility of the patient. This variable will be collected for detecting cognitive impairment of the patient.
Gender 12 months This is a socio demographic outcome. This outcome will be collected as Male or Female.
Hand dominance 12 months This is a socio demographic outcome. This outcome will be collected as right-handed and left-handed.
Education level 12 months This is a socio demographic outcome.
Fatigue Severity Scale 12 months 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.
Total Cholesterol 12 months This is a blood test for measure the lipidic profile of the patient.
LDL 12 months This is a blood test for measure the lipidic profile of the patient.
Charlson Comorbidity Index 12 months This an outcome to evaluate the eligibility of the patient.
Deprivation index 12 months This is a socio demographic outcome.
Berg Balance Scale 12 months This is a neurological physical examination.
Frenchay Arm Test 12 months This is a neurological physical examination.
Asworth Modified Scale 12 months 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).
Analogic Visual Scale 12 months This is a neurological physical examination.
Analgesic Treatments 12 months This is a neurological physical examination.
Glycaemia 12 months This is a cardiovascular risk factor.
Mediterranean Diet Assessment Test 12 months This is for measure the life style of the patient.
Hobbies 12 months This is a socio demographic outcome.
Medical Research Council Scale 12 months Scale for testing muscle strength in palsy. There are no subscales. It measures from Grade 0 (No contraction) to Grade 5 (Normal strength).
MoCA Test 12 months This is a neurological physical examination.
10 Meters Walking Test 12 months This is a neurological physical examination. The variable will collected in m/sg.
Line Bisection Test 12 months This is a neurological physical examination.
Height 12 months This is a cardiovascular risk factor. In meter
BMI 12 months This is a cardiovascular risk factor.
Waist to Hip Ratio 12 months This is a cardiovascular risk factor.
Blood Pressure 12 months This is a cardiovascular risk factor. In mmHg
Campimetry 12 months This is a neurological physical examination.
Heart Rate 12 months This is a cardiovascular risk factor.
Proteins 12 months This is a blood test of the patient.
Apoportein A1 12 months This is a blood test of the patient.
Lawton Index 12 months This is to messure the activities of daily living of the patient.
SF-36 12 months This is to messure the quality of life of the patient.
SIS 12 months This is to messure the quality of life of the patient.
Pharmacological Accountability 12 months This is to messure the adherence to the treatment of the patient.
Waist Size 12 months This is a cardiovascular risk factor.
Toxic Consumption 12 months This is for measure the life style of the patient.
HDL 12 months This is a blood test for measure the lipidic profile of the patient.
HbA1c 12 months This is a blood test of the patient.
Apoprotein B 12 months This is a blood test of the patient.
Stroke Self Management Questionary 12 months This is to messure the self management satisfaction of the patient.
Post Stroke Checklist 12 months This is to messure the adherence to the treatment of the patient.
Non Pharmacological Accountability 12 months This is to messure the adherence to the treatment of the patient.
Stroke Management Questionary 12 months This is to messure the self management satisfaction of the patient.
Satisfaction Questionary 12 months This is to messure the self management satisfaction of the patient.
Stroke Recurrences 12 months This is to messure the complications of the patient.
Trial Locations
- Locations (1)
Hospital Universitario Cruces
🇪🇸Barakaldo, Bizkaia, Spain