Clinical trial NCT03580642: Decision Support System for Stroke Survivors
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Telerehabilitation
Stroke
Life Style
Lead sponsor: Biocruces Bizkaia Health Research Institute
Sponsor class: OTHER_GOV
First posted: 2018-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: System Usability Scale
timeFrame: 12 months
Secondary outcomes:
measure: Age
timeFrame: 12 months
measure: Stroke date
timeFrame: 12 months
measure: Oxfordshire Community Stroke Project Classification
timeFrame: 12 months
measure: Modified Barthel Index
timeFrame: 12 months
measure: Mississippi Aphasia Screening Test
timeFrame: 12 months
measure: Montreal Cognitive Assessment
timeFrame: 12 months
measure: Gijon's social-familial evaluation Scale
timeFrame: 12 months
measure: Charlson Comorbidity Index
timeFrame: 12 months
measure: Gender
timeFrame: 12 months
measure: Ethnic group
timeFrame: 12 months
measure: Deprivation index
timeFrame: 12 months
measure: Hand dominance
timeFrame: 12 months
measure: Education level
timeFrame: 12 months
measure: Type of profession
timeFrame: 12 months
measure: Hobbies
timeFrame: 12 months
measure: Medical Research Council Scale
timeFrame: 12 months
measure: MAST Test
timeFrame: 12 months
measure: MoCA Test
timeFrame: 12 months
measure: Functional Ambulation Categories
timeFrame: 12 months
measure: 10 Meters Walking Test
timeFrame: 12 months
measure: 6 Minutes Walking Test
timeFrame: 12 months
measure: Berg Balance Scale
timeFrame: 12 months
measure: Frenchay Arm Test
timeFrame: 12 months
measure: Asworth Modified Scale
timeFrame: 12 months
measure: Fatigue Severity Scale
timeFrame: 12 months
measure: Line Bisection Test
timeFrame: 12 months
measure: Disphagia
timeFrame: 12 months
measure: Campimetry
timeFrame: 12 months
measure: Analogic Visual Scale
timeFrame: 12 months
measure: Analgesic Treatments
timeFrame: 12 months
measure: Golberg Scale
timeFrame: 12 months
measure: Weight
timeFrame: 12 months
measure: Height
timeFrame: 12 months
measure: BMI
timeFrame: 12 months
measure: Waist Size
timeFrame: 12 months
measure: Waist to Hip Ratio
timeFrame: 12 months
measure: Blood Pressure
timeFrame: 12 months
measure: Heart Rate
timeFrame: 12 months
measure: Glycaemia
timeFrame: 12 months
measure: Health Literacy Test
timeFrame: 12 months
measure: Mediterranean Diet Assessment Test
timeFrame: 12 months
measure: Physical Activity
timeFrame: 12 months
measure: Toxic Consumption
timeFrame: 12 months
measure: Total Cholesterol
timeFrame: 12 months
measure: HDL
timeFrame: 12 months
measure: LDL
timeFrame: 12 months
measure: Proteins
timeFrame: 12 months
measure: Albumin
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 months
measure: Apoprotein B
timeFrame: 12 months
measure: Apoportein A1
timeFrame: 12 months
measure: Lawton Index
timeFrame: 12 months
measure: SF-36
timeFrame: 12 months
measure: SIS
timeFrame: 12 months
measure: Stroke Self Management Questionary
timeFrame: 12 months
measure: Stroke Management Questionary
timeFrame: 12 months
measure: Satisfaction Questionary
timeFrame: 12 months
measure: Post Stroke Checklist
timeFrame: 12 months
measure: Pharmacological Accountability
timeFrame: 12 months
measure: Non Pharmacological Accountability
timeFrame: 12 months
measure: Stroke Recurrences
timeFrame: 12 months
measure: Number of Readmissions
timeFrame: 12 months
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Bizkaia
Study officials:
References: