NCT03580642

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

April 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

December 22, 2017

Last Update Submit

July 23, 2018

Conditions

TelerehabilitationStrokeLife Style

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (62)

  • Age

    12 months

  • Stroke date

    12 months

  • Oxfordshire Community Stroke Project Classification

    12 months

  • Modified Barthel Index

    12 months

  • Mississippi Aphasia Screening Test

    12 months

  • +57 more secondary outcomes

Study Arms (2)

eHealth Technologies

EXPERIMENTAL

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

Device: eHealth Technologies

Control

NO INTERVENTION

Habitual treatment.

Interventions

eHealth TechnologiesDEVICE

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.

eHealth Technologies

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Cruces

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Leire Ortiz

CONTACT

+ 34 685779523LEIRE.ORTIZFERNANDEZ@osakidetza.eus

Joana Sagastagoya

CONTACT

+ 34 94 600 6000JOANA.SAGASTAGOYAZABALA@osakidetza.eus

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2017

First Posted

July 9, 2018

Study Start

April 27, 2018

Primary Completion

February 1, 2019

Study Completion

December 1, 2019

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)