Decision Support System for Stroke Survivors

Stroke Clinical Trial

— STARR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03580642
• Other study ID #: STARR
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: July 2018
• Source: Asociación Instituto de Investigación Sanitaria BioCruces
• Contact: Leire Ortiz
• Phone: + 34 685779523
• Email: LEIRE.ORTIZFERNANDEZ[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Life Style
• Stroke
• Telerehabilitation

Intervention

Device:
• eHealth Technologies
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Cruces	Barakaldo	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
Asociación Instituto de Investigación Sanitaria BioCruces

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Age	This an outcome to evaluate the eligibility of the patient. Age variable will be in years.	12 months
Secondary	Stroke date	This an outcome to evaluate the eligibility of the patient. This variable will be the patient stroke date.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Charlson Comorbidity Index	This an outcome to evaluate the eligibility of the patient.	12 months
Secondary	Gender	This is a socio demographic outcome. This outcome will be collected as Male or Female.	12 months
Secondary	Ethnic group	This is a socio demographic outcome.	12 months
Secondary	Deprivation index	This is a socio demographic outcome.	12 months
Secondary	Hand dominance	This is a socio demographic outcome. This outcome will be collected as right-handed and left-handed.	12 months
Secondary	Education level	This is a socio demographic outcome.	12 months
Secondary	Type of profession	This is a socio demographic outcome.	12 months
Secondary	Hobbies	This is a socio demographic outcome.	12 months
Secondary	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).	12 months
Secondary	MAST Test	This is a neurological physical examination.	12 months
Secondary	MoCA Test	This is a neurological physical examination.	12 months
Secondary	Functional Ambulation Categories	This is a neurological physical examination.	12 months
Secondary	10 Meters Walking Test	This is a neurological physical examination. The variable will collected in m/sg.	12 months
Secondary	6 Minutes Walking Test	This is a neurological physical examination. The variable will collected in metres.	12 months
Secondary	Berg Balance Scale	This is a neurological physical examination.	12 months
Secondary	Frenchay Arm Test	This is a neurological physical examination.	12 months
Secondary	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).	12 months
Secondary	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.	12 months
Secondary	Line Bisection Test	This is a neurological physical examination.	12 months
Secondary	Disphagia	This is a neurological physical examination.	12 months
Secondary	Campimetry	This is a neurological physical examination.	12 months
Secondary	Analogic Visual Scale	This is a neurological physical examination.	12 months
Secondary	Analgesic Treatments	This is a neurological physical examination.	12 months
Secondary	Golberg Scale	This is a cardiovascular risk factor. To messure depression and anxiety.	12 months
Secondary	Weight	This is a cardiovascular risk factor. In kg	12 months
Secondary	Height	This is a cardiovascular risk factor. In meter	12 months
Secondary	BMI	This is a cardiovascular risk factor.	12 months
Secondary	Waist Size	This is a cardiovascular risk factor.	12 months
Secondary	Waist to Hip Ratio	This is a cardiovascular risk factor.	12 months
Secondary	Blood Pressure	This is a cardiovascular risk factor. In mmHg	12 months
Secondary	Heart Rate	This is a cardiovascular risk factor.	12 months
Secondary	Glycaemia	This is a cardiovascular risk factor.	12 months
Secondary	Health Literacy Test	This is for measure the health literacy of the patient.	12 months
Secondary	Mediterranean Diet Assessment Test	This is for measure the life style of the patient.	12 months
Secondary	Physical Activity	This is for measure the life style of the patient.	12 months
Secondary	Toxic Consumption	This is for measure the life style of the patient.	12 months
Secondary	Total Cholesterol	This is a blood test for measure the lipidic profile of the patient.	12 months
Secondary	HDL	This is a blood test for measure the lipidic profile of the patient.	12 months
Secondary	LDL	This is a blood test for measure the lipidic profile of the patient.	12 months
Secondary	Proteins	This is a blood test of the patient.	12 months
Secondary	Albumin	This is a blood test of the patient.	12 months
Secondary	HbA1c	This is a blood test of the patient.	12 months
Secondary	Apoprotein B	This is a blood test of the patient.	12 months
Secondary	Apoportein A1	This is a blood test of the patient.	12 months
Secondary	Lawton Index	This is to messure the activities of daily living of the patient.	12 months
Secondary	SF-36	This is to messure the quality of life of the patient.	12 months
Secondary	SIS	This is to messure the quality of life of the patient.	12 months
Secondary	Stroke Self Management Questionary	This is to messure the self management satisfaction of the patient.	12 months
Secondary	Stroke Management Questionary	This is to messure the self management satisfaction of the patient.	12 months
Secondary	Satisfaction Questionary	This is to messure the self management satisfaction of the patient.	12 months
Secondary	Post Stroke Checklist	This is to messure the adherence to the treatment of the patient.	12 months
Secondary	Pharmacological Accountability	This is to messure the adherence to the treatment of the patient.	12 months
Secondary	Non Pharmacological Accountability	This is to messure the adherence to the treatment of the patient.	12 months
Secondary	Stroke Recurrences	This is to messure the complications of the patient.	12 months
Secondary	Number of Readmissions	This is to messure the complications of the patient.	12 months