Decision Support System for Stroke Survivors

Biobizkaia Health Research Institute40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Telerehabilitation Stroke Life Style

Interventions

eHealth TechnologiesDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Cruces

Barakaldo, Bizkaia, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Age

This an outcome to evaluate the eligibility of the patient. Age variable will be in years.

Time frame: 12 months

Stroke date

This an outcome to evaluate the eligibility of the patient. This variable will be the patient stroke date.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Leire Ortiz

CONTACT

+ 34 685779523 LEIRE.ORTIZFERNANDEZ@osakidetza.eus

Joana Sagastagoya

CONTACT

+ 34 94 600 6000 JOANA.SAGASTAGOYAZABALA@osakidetza.eus

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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.

Time frame: 12 months

Charlson Comorbidity Index

This an outcome to evaluate the eligibility of the patient.

Time frame: 12 months

Gender

This is a socio demographic outcome. This outcome will be collected as Male or Female.

Time frame: 12 months

Ethnic group

This is a socio demographic outcome.

Time frame: 12 months

Deprivation index

This is a socio demographic outcome.

Time frame: 12 months

Hand dominance

This is a socio demographic outcome. This outcome will be collected as right-handed and left-handed.

Time frame: 12 months

Education level

This is a socio demographic outcome.

Time frame: 12 months

Type of profession

This is a socio demographic outcome.

Time frame: 12 months

Hobbies

This is a socio demographic outcome.

Time frame: 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).

Time frame: 12 months

MAST Test

This is a neurological physical examination.

Time frame: 12 months

MoCA Test

This is a neurological physical examination.

Time frame: 12 months

Functional Ambulation Categories

This is a neurological physical examination.

Time frame: 12 months

10 Meters Walking Test

This is a neurological physical examination. The variable will collected in m/sg.

Time frame: 12 months

6 Minutes Walking Test

This is a neurological physical examination. The variable will collected in metres.

Time frame: 12 months

Berg Balance Scale

This is a neurological physical examination.

Time frame: 12 months

Frenchay Arm Test

This is a neurological physical examination.

Time frame: 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).

Time frame: 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.

Time frame: 12 months

Line Bisection Test

This is a neurological physical examination.

Time frame: 12 months

Disphagia

This is a neurological physical examination.

Time frame: 12 months

Campimetry

This is a neurological physical examination.

Time frame: 12 months

Analogic Visual Scale

This is a neurological physical examination.

Time frame: 12 months

Analgesic Treatments

This is a neurological physical examination.

Time frame: 12 months

Golberg Scale

This is a cardiovascular risk factor. To messure depression and anxiety.

Time frame: 12 months

Weight

This is a cardiovascular risk factor. In kg

Time frame: 12 months

Height

This is a cardiovascular risk factor. In meter

Time frame: 12 months

BMI

This is a cardiovascular risk factor.

Time frame: 12 months

Waist Size

This is a cardiovascular risk factor.

Time frame: 12 months

Waist to Hip Ratio

This is a cardiovascular risk factor.

Time frame: 12 months

Blood Pressure

This is a cardiovascular risk factor. In mmHg

Time frame: 12 months

Heart Rate

This is a cardiovascular risk factor.

Time frame: 12 months

Glycaemia

This is a cardiovascular risk factor.

Time frame: 12 months

Health Literacy Test

This is for measure the health literacy of the patient.

Time frame: 12 months

Mediterranean Diet Assessment Test

This is for measure the life style of the patient.

Time frame: 12 months

Physical Activity

This is for measure the life style of the patient.

Time frame: 12 months

Toxic Consumption

This is for measure the life style of the patient.

Time frame: 12 months

Total Cholesterol

This is a blood test for measure the lipidic profile of the patient.

Time frame: 12 months

HDL

This is a blood test for measure the lipidic profile of the patient.

Time frame: 12 months

LDL

This is a blood test for measure the lipidic profile of the patient.

Time frame: 12 months

Proteins

This is a blood test of the patient.

Time frame: 12 months

Albumin

This is a blood test of the patient.

Time frame: 12 months

HbA1c

This is a blood test of the patient.

Time frame: 12 months

Apoprotein B

This is a blood test of the patient.

Time frame: 12 months

Apoportein A1

This is a blood test of the patient.

Time frame: 12 months

Lawton Index

This is to messure the activities of daily living of the patient.

Time frame: 12 months

SF-36

This is to messure the quality of life of the patient.

Time frame: 12 months

SIS

This is to messure the quality of life of the patient.

Time frame: 12 months

Stroke Self Management Questionary

This is to messure the self management satisfaction of the patient.

Time frame: 12 months

Stroke Management Questionary

This is to messure the self management satisfaction of the patient.

Time frame: 12 months

Satisfaction Questionary

This is to messure the self management satisfaction of the patient.

Time frame: 12 months

Post Stroke Checklist

This is to messure the adherence to the treatment of the patient.

Time frame: 12 months

Pharmacological Accountability

This is to messure the adherence to the treatment of the patient.

Time frame: 12 months

Non Pharmacological Accountability

This is to messure the adherence to the treatment of the patient.

Time frame: 12 months

Stroke Recurrences

This is to messure the complications of the patient.

Time frame: 12 months

Number of Readmissions

This is to messure the complications of the patient.

Time frame: 12 months