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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- System Usability Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
eHealth Technologies
eHealth Technologies is a messure of diferent paramenters of the patient; heart rate, blood pressure, weight, thermometer, daily activity.
Intervention: eHealth Technologies (Device)
Control
Habitual treatment.
Outcomes
Primary Outcomes
System Usability Scale
Time Frame: 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 Outcomes
- Physical Activity(12 months)
- Line Bisection Test(12 months)
- Health Literacy Test(12 months)
- Age(12 months)
- Oxfordshire Community Stroke Project Classification(12 months)
- Gijon's social-familial evaluation Scale(12 months)
- Ethnic group(12 months)
- Type of profession(12 months)
- MAST Test(12 months)
- Functional Ambulation Categories(12 months)
- 6 Minutes Walking Test(12 months)
- Disphagia(12 months)
- Stroke date(12 months)
- Modified Barthel Index(12 months)
- Mississippi Aphasia Screening Test(12 months)
- Montreal Cognitive Assessment(12 months)
- Gender(12 months)
- Hand dominance(12 months)
- Education level(12 months)
- Fatigue Severity Scale(12 months)
- Total Cholesterol(12 months)
- LDL(12 months)
- Albumin(12 months)
- Charlson Comorbidity Index(12 months)
- Deprivation index(12 months)
- Berg Balance Scale(12 months)
- Frenchay Arm Test(12 months)
- Asworth Modified Scale(12 months)
- Analogic Visual Scale(12 months)
- Analgesic Treatments(12 months)
- Glycaemia(12 months)
- Mediterranean Diet Assessment Test(12 months)
- Hobbies(12 months)
- Medical Research Council Scale(12 months)
- MoCA Test(12 months)
- 10 Meters Walking Test(12 months)
- Golberg Scale(12 months)
- Weight(12 months)
- Height(12 months)
- BMI(12 months)
- Waist to Hip Ratio(12 months)
- Blood Pressure(12 months)
- Campimetry(12 months)
- Heart Rate(12 months)
- Proteins(12 months)
- Apoportein A1(12 months)
- Lawton Index(12 months)
- SF-36(12 months)
- Pharmacological Accountability(12 months)
- Waist Size(12 months)
- Toxic Consumption(12 months)
- HDL(12 months)
- SIS(12 months)
- Number of Readmissions(12 months)
- HbA1c(12 months)
- Apoprotein B(12 months)
- Stroke Self Management Questionary(12 months)
- Post Stroke Checklist(12 months)
- Non Pharmacological Accountability(12 months)
- Stroke Management Questionary(12 months)
- Satisfaction Questionary(12 months)
- Stroke Recurrences(12 months)
Investigators
Leire Ortiz Fernández
Principal Investigator
Biocruces Bizkaia Health Research Institute