- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580642
Decision Support System for Stroke Survivors (STARR)
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
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leire Ortiz
- Phone Number: + 34 685779523
- Email: LEIRE.ORTIZFERNANDEZ@osakidetza.eus
Study Contact Backup
- Name: Joana Sagastagoya
- Phone Number: 63 67 + 34 94 600 6000
- Email: JOANA.SAGASTAGOYAZABALA@osakidetza.eus
Study Locations
-
-
Bizkaia
-
Barakaldo, Bizkaia, Spain, 48903
- Recruiting
- Hospital Universitario Cruces
-
Contact:
- Leire Ortiz
- Phone Number: +34 685779523
- Email: LEIRE.ORTIZFERNANDEZ@osakidetza.eus
-
Contact:
- Joana JOANA.SAGASTAGOYAZABALA@osakidetza.eus
- Phone Number: 63 67 +34 94 600 6000
- Email: JOANA.SAGASTAGOYAZABALA@osakidetza.eus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: eHealth Technologies
eHealth Technologies is a messure of diferent paramenters of the patient; heart rate, blood pressure, weight, thermometer, daily activity.
|
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.
|
NO_INTERVENTION: Control
Habitual treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: 12 months
|
This an outcome to evaluate the eligibility of the patient.
Age variable will be in years.
|
12 months
|
Stroke date
Time Frame: 12 months
|
This an outcome to evaluate the eligibility of the patient.
This variable will be the patient stroke date.
|
12 months
|
Oxfordshire Community Stroke Project Classification
Time Frame: 12 months
|
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
|
Modified Barthel Index
Time Frame: 12 months
|
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
|
Mississippi Aphasia Screening Test
Time Frame: 12 months
|
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
|
Montreal Cognitive Assessment
Time Frame: 12 months
|
This an outcome to evaluate the eligibility of the patient.
This variable will be collected for detecting cognitive impairment of the patient.
|
12 months
|
Gijon's social-familial evaluation Scale
Time Frame: 12 months
|
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
|
Charlson Comorbidity Index
Time Frame: 12 months
|
This an outcome to evaluate the eligibility of the patient.
|
12 months
|
Gender
Time Frame: 12 months
|
This is a socio demographic outcome.
This outcome will be collected as Male or Female.
|
12 months
|
Ethnic group
Time Frame: 12 months
|
This is a socio demographic outcome.
|
12 months
|
Deprivation index
Time Frame: 12 months
|
This is a socio demographic outcome.
|
12 months
|
Hand dominance
Time Frame: 12 months
|
This is a socio demographic outcome.
This outcome will be collected as right-handed and left-handed.
|
12 months
|
Education level
Time Frame: 12 months
|
This is a socio demographic outcome.
|
12 months
|
Type of profession
Time Frame: 12 months
|
This is a socio demographic outcome.
|
12 months
|
Hobbies
Time Frame: 12 months
|
This is a socio demographic outcome.
|
12 months
|
Medical Research Council Scale
Time Frame: 12 months
|
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
|
MAST Test
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
MoCA Test
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
Functional Ambulation Categories
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
10 Meters Walking Test
Time Frame: 12 months
|
This is a neurological physical examination.
The variable will collected in m/sg.
|
12 months
|
6 Minutes Walking Test
Time Frame: 12 months
|
This is a neurological physical examination.
The variable will collected in metres.
|
12 months
|
Berg Balance Scale
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
Frenchay Arm Test
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
Asworth Modified Scale
Time Frame: 12 months
|
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
|
Fatigue Severity Scale
Time Frame: 12 months
|
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
|
Line Bisection Test
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
Disphagia
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
Campimetry
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
Analogic Visual Scale
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
Analgesic Treatments
Time Frame: 12 months
|
This is a neurological physical examination.
|
12 months
|
Golberg Scale
Time Frame: 12 months
|
This is a cardiovascular risk factor.
To messure depression and anxiety.
|
12 months
|
Weight
Time Frame: 12 months
|
This is a cardiovascular risk factor.
In kg
|
12 months
|
Height
Time Frame: 12 months
|
This is a cardiovascular risk factor.
In meter
|
12 months
|
BMI
Time Frame: 12 months
|
This is a cardiovascular risk factor.
|
12 months
|
Waist Size
Time Frame: 12 months
|
This is a cardiovascular risk factor.
|
12 months
|
Waist to Hip Ratio
Time Frame: 12 months
|
This is a cardiovascular risk factor.
|
12 months
|
Blood Pressure
Time Frame: 12 months
|
This is a cardiovascular risk factor.
In mmHg
|
12 months
|
Heart Rate
Time Frame: 12 months
|
This is a cardiovascular risk factor.
|
12 months
|
Glycaemia
Time Frame: 12 months
|
This is a cardiovascular risk factor.
|
12 months
|
Health Literacy Test
Time Frame: 12 months
|
This is for measure the health literacy of the patient.
|
12 months
|
Mediterranean Diet Assessment Test
Time Frame: 12 months
|
This is for measure the life style of the patient.
|
12 months
|
Physical Activity
Time Frame: 12 months
|
This is for measure the life style of the patient.
|
12 months
|
Toxic Consumption
Time Frame: 12 months
|
This is for measure the life style of the patient.
|
12 months
|
Total Cholesterol
Time Frame: 12 months
|
This is a blood test for measure the lipidic profile of the patient.
|
12 months
|
HDL
Time Frame: 12 months
|
This is a blood test for measure the lipidic profile of the patient.
|
12 months
|
LDL
Time Frame: 12 months
|
This is a blood test for measure the lipidic profile of the patient.
|
12 months
|
Proteins
Time Frame: 12 months
|
This is a blood test of the patient.
|
12 months
|
Albumin
Time Frame: 12 months
|
This is a blood test of the patient.
|
12 months
|
HbA1c
Time Frame: 12 months
|
This is a blood test of the patient.
|
12 months
|
Apoprotein B
Time Frame: 12 months
|
This is a blood test of the patient.
|
12 months
|
Apoportein A1
Time Frame: 12 months
|
This is a blood test of the patient.
|
12 months
|
Lawton Index
Time Frame: 12 months
|
This is to messure the activities of daily living of the patient.
|
12 months
|
SF-36
Time Frame: 12 months
|
This is to messure the quality of life of the patient.
|
12 months
|
SIS
Time Frame: 12 months
|
This is to messure the quality of life of the patient.
|
12 months
|
Stroke Self Management Questionary
Time Frame: 12 months
|
This is to messure the self management satisfaction of the patient.
|
12 months
|
Stroke Management Questionary
Time Frame: 12 months
|
This is to messure the self management satisfaction of the patient.
|
12 months
|
Satisfaction Questionary
Time Frame: 12 months
|
This is to messure the self management satisfaction of the patient.
|
12 months
|
Post Stroke Checklist
Time Frame: 12 months
|
This is to messure the adherence to the treatment of the patient.
|
12 months
|
Pharmacological Accountability
Time Frame: 12 months
|
This is to messure the adherence to the treatment of the patient.
|
12 months
|
Non Pharmacological Accountability
Time Frame: 12 months
|
This is to messure the adherence to the treatment of the patient.
|
12 months
|
Stroke Recurrences
Time Frame: 12 months
|
This is to messure the complications of the patient.
|
12 months
|
Number of Readmissions
Time Frame: 12 months
|
This is to messure the complications of the patient.
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STARR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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