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Decision Support System for Stroke Survivors (STARR)

Primary Purpose

Telerehabilitation, Stroke, Life Style

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
eHealth Technologies
Sponsored by
Biocruces Bizkaia Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Telerehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario CrucesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eHealth Technologies

Control

Arm Description

eHealth Technologies is a messure of diferent paramenters of the patient; heart rate, blood pressure, weight, thermometer, daily activity.

Habitual treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2017
Last Updated
July 23, 2018
Sponsor
Biocruces Bizkaia Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03580642
Brief Title
Decision Support System for Stroke Survivors
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biocruces Bizkaia Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation, Stroke, Life Style

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eHealth Technologies
Arm Type
Experimental
Arm Description
eHealth Technologies is a messure of diferent paramenters of the patient; heart rate, blood pressure, weight, thermometer, daily activity.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Habitual treatment.
Intervention Type
Device
Intervention Name(s)
eHealth Technologies
Intervention Description
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.
Primary Outcome Measure Information:
Title
System Usability Scale
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Age
Description
This an outcome to evaluate the eligibility of the patient. Age variable will be in years.
Time Frame
12 months
Title
Stroke date
Description
This an outcome to evaluate the eligibility of the patient. This variable will be the patient stroke date.
Time Frame
12 months
Title
Oxfordshire Community Stroke Project Classification
Description
This an outcome to evaluate the eligibility of the patient. This variable will be useful in estimation of after stroke complications and prognostication.
Time Frame
12 months
Title
Modified Barthel Index
Description
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.
Time Frame
12 months
Title
Mississippi Aphasia Screening Test
Description
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.
Time Frame
12 months
Title
Montreal Cognitive Assessment
Description
This an outcome to evaluate the eligibility of the patient. This variable will be collected for detecting cognitive impairment of the patient.
Time Frame
12 months
Title
Gijon's social-familial evaluation Scale
Description
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.
Time Frame
12 months
Title
Charlson Comorbidity Index
Description
This an outcome to evaluate the eligibility of the patient.
Time Frame
12 months
Title
Gender
Description
This is a socio demographic outcome. This outcome will be collected as Male or Female.
Time Frame
12 months
Title
Ethnic group
Description
This is a socio demographic outcome.
Time Frame
12 months
Title
Deprivation index
Description
This is a socio demographic outcome.
Time Frame
12 months
Title
Hand dominance
Description
This is a socio demographic outcome. This outcome will be collected as right-handed and left-handed.
Time Frame
12 months
Title
Education level
Description
This is a socio demographic outcome.
Time Frame
12 months
Title
Type of profession
Description
This is a socio demographic outcome.
Time Frame
12 months
Title
Hobbies
Description
This is a socio demographic outcome.
Time Frame
12 months
Title
Medical Research Council Scale
Description
Scale for testing muscle strength in palsy. There are no subscales. It measures from Grade 0 (No contraction) to Grade 5 (Normal strength).
Time Frame
12 months
Title
MAST Test
Description
This is a neurological physical examination.
Time Frame
12 months
Title
MoCA Test
Description
This is a neurological physical examination.
Time Frame
12 months
Title
Functional Ambulation Categories
Description
This is a neurological physical examination.
Time Frame
12 months
Title
10 Meters Walking Test
Description
This is a neurological physical examination. The variable will collected in m/sg.
Time Frame
12 months
Title
6 Minutes Walking Test
Description
This is a neurological physical examination. The variable will collected in metres.
Time Frame
12 months
Title
Berg Balance Scale
Description
This is a neurological physical examination.
Time Frame
12 months
Title
Frenchay Arm Test
Description
This is a neurological physical examination.
Time Frame
12 months
Title
Asworth Modified Scale
Description
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).
Time Frame
12 months
Title
Fatigue Severity Scale
Description
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.
Time Frame
12 months
Title
Line Bisection Test
Description
This is a neurological physical examination.
Time Frame
12 months
Title
Disphagia
Description
This is a neurological physical examination.
Time Frame
12 months
Title
Campimetry
Description
This is a neurological physical examination.
Time Frame
12 months
Title
Analogic Visual Scale
Description
This is a neurological physical examination.
Time Frame
12 months
Title
Analgesic Treatments
Description
This is a neurological physical examination.
Time Frame
12 months
Title
Golberg Scale
Description
This is a cardiovascular risk factor. To messure depression and anxiety.
Time Frame
12 months
Title
Weight
Description
This is a cardiovascular risk factor. In kg
Time Frame
12 months
Title
Height
Description
This is a cardiovascular risk factor. In meter
Time Frame
12 months
Title
BMI
Description
This is a cardiovascular risk factor.
Time Frame
12 months
Title
Waist Size
Description
This is a cardiovascular risk factor.
Time Frame
12 months
Title
Waist to Hip Ratio
Description
This is a cardiovascular risk factor.
Time Frame
12 months
Title
Blood Pressure
Description
This is a cardiovascular risk factor. In mmHg
Time Frame
12 months
Title
Heart Rate
Description
This is a cardiovascular risk factor.
Time Frame
12 months
Title
Glycaemia
Description
This is a cardiovascular risk factor.
Time Frame
12 months
Title
Health Literacy Test
Description
This is for measure the health literacy of the patient.
Time Frame
12 months
Title
Mediterranean Diet Assessment Test
Description
This is for measure the life style of the patient.
Time Frame
12 months
Title
Physical Activity
Description
This is for measure the life style of the patient.
Time Frame
12 months
Title
Toxic Consumption
Description
This is for measure the life style of the patient.
Time Frame
12 months
Title
Total Cholesterol
Description
This is a blood test for measure the lipidic profile of the patient.
Time Frame
12 months
Title
HDL
Description
This is a blood test for measure the lipidic profile of the patient.
Time Frame
12 months
Title
LDL
Description
This is a blood test for measure the lipidic profile of the patient.
Time Frame
12 months
Title
Proteins
Description
This is a blood test of the patient.
Time Frame
12 months
Title
Albumin
Description
This is a blood test of the patient.
Time Frame
12 months
Title
HbA1c
Description
This is a blood test of the patient.
Time Frame
12 months
Title
Apoprotein B
Description
This is a blood test of the patient.
Time Frame
12 months
Title
Apoportein A1
Description
This is a blood test of the patient.
Time Frame
12 months
Title
Lawton Index
Description
This is to messure the activities of daily living of the patient.
Time Frame
12 months
Title
SF-36
Description
This is to messure the quality of life of the patient.
Time Frame
12 months
Title
SIS
Description
This is to messure the quality of life of the patient.
Time Frame
12 months
Title
Stroke Self Management Questionary
Description
This is to messure the self management satisfaction of the patient.
Time Frame
12 months
Title
Stroke Management Questionary
Description
This is to messure the self management satisfaction of the patient.
Time Frame
12 months
Title
Satisfaction Questionary
Description
This is to messure the self management satisfaction of the patient.
Time Frame
12 months
Title
Post Stroke Checklist
Description
This is to messure the adherence to the treatment of the patient.
Time Frame
12 months
Title
Pharmacological Accountability
Description
This is to messure the adherence to the treatment of the patient.
Time Frame
12 months
Title
Non Pharmacological Accountability
Description
This is to messure the adherence to the treatment of the patient.
Time Frame
12 months
Title
Stroke Recurrences
Description
This is to messure the complications of the patient.
Time Frame
12 months
Title
Number of Readmissions
Description
This is to messure the complications of the patient.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leire Ortiz
Phone
+ 34 685779523
Email
LEIRE.ORTIZFERNANDEZ@osakidetza.eus
First Name & Middle Initial & Last Name or Official Title & Degree
Joana Sagastagoya
Phone
+ 34 94 600 6000
Ext
63 67
Email
JOANA.SAGASTAGOYAZABALA@osakidetza.eus
Facility Information:
Facility Name
Hospital Universitario Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leire Ortiz
Phone
+34 685779523
Email
LEIRE.ORTIZFERNANDEZ@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Joana JOANA.SAGASTAGOYAZABALA@osakidetza.eus
Phone
+34 94 600 6000
Ext
63 67
Email
JOANA.SAGASTAGOYAZABALA@osakidetza.eus

12. IPD Sharing Statement

Plan to Share IPD
No

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Decision Support System for Stroke Survivors

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