Decision Support System for Stroke Survivors (STARR)

July 23, 2018 updated by: Leire Ortiz Fernández, Biocruces Bizkaia Health Research Institute

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

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 27, 2018

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

June 26, 2018

First Posted (ACTUAL)

July 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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