Decision Support System for Stroke Survivors

NCT ID: NCT03580642

Last Updated: 2018-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2019-12-01

Brief Summary

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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

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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.

Conditions

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Telerehabilitation Stroke Life Style

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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eHealth Technologies

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

Group Type EXPERIMENTAL

eHealth Technologies

Intervention Type DEVICE

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.

Control

Habitual treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biocruces Bizkaia Health Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Leire Ortiz Fernández

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Cruces

Barakaldo, Bizkaia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Leire Ortiz

Role: CONTACT

+ 34 685779523

Joana Sagastagoya

Role: CONTACT

+ 34 94 600 6000 ext. 63 67

Facility Contacts

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Leire Ortiz

Role: primary

+34 685779523

Joana [email protected]

Role: backup

+34 94 600 6000 ext. 63 67

Other Identifiers

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STARR

Identifier Type: -

Identifier Source: org_study_id

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