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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- System Usability Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
eHealth Technologies
eHealth Technologies is a messure of diferent paramenters of the patient; heart rate, blood pressure, weight, thermometer, daily activity.
干预措施: eHealth Technologies (Device)
Control
Habitual treatment.
结局指标
主要结局
System Usability Scale
时间窗: 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.
次要结局
- 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)
研究者
Leire Ortiz Fernández
Principal Investigator
Biocruces Bizkaia Health Research Institute