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TelerehabilitationSTARRNCT03580642

Decision Support System for Stroke Survivors

A study testing eHealth Technologies in people with Telerehabilitation and Stroke, run by Biobizkaia Health Research Institute at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Telerehabilitation, Stroke, Life Style
What is being tested?
eHealth Technologies
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
27 Apr 2018to 1 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Leire Ortiz contact

+ 34 685779523

LEIRE.ORTIZFERNANDEZ@osakidetza.eus

Joana Sagastagoya contact

+ 34 94 600 6000 ext. 63 67

JOANA.SAGASTAGOYAZABALA@osakidetza.eus

Spain1 site, 1 recruiting

  • Hospital Universitario Cruces

    Barakaldo, Bizkaia, 48903

    Leire Ortiz, +34 685779523, LEIRE.ORTIZFERNANDEZ@osakidetza.eus

    Joana JOANA.SAGASTAGOYAZABALA@osakidetza.eus, +34 94 600 6000 ext. 63 67, JOANA.SAGASTAGOYAZABALA@osakidetza.eus

    Recruiting

Other trials in Spain

About this study

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

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.
Read the 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.

Being tested
eHealth Technologies
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03580642
Study groupRoleWhat they receive
eHealth TechnologiesExperimentaleHealth Technologies is a messure of diferent paramenters of the patient; heart rate, blood pressure, weight, thermometer, daily activity.
Receives: Device: eHealth Technologies
ControlNo interventionHabitual treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (62)

  1. Age

    This an outcome to evaluate the eligibility of the patient. Age variable will be in years.

    Measured: 12 months

  2. Stroke date

    This an outcome to evaluate the eligibility of the patient. This variable will be the patient stroke date.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. Charlson Comorbidity Index

    This an outcome to evaluate the eligibility of the patient.

    Measured: 12 months

  9. Gender

    This is a socio demographic outcome. This outcome will be collected as Male or Female.

    Measured: 12 months

  10. Ethnic group

    This is a socio demographic outcome.

    Measured: 12 months

  11. Deprivation index

    This is a socio demographic outcome.

    Measured: 12 months

  12. Hand dominance

    This is a socio demographic outcome. This outcome will be collected as right-handed and left-handed.

    Measured: 12 months

  13. Education level

    This is a socio demographic outcome.

    Measured: 12 months

  14. Type of profession

    This is a socio demographic outcome.

    Measured: 12 months

  15. Hobbies

    This is a socio demographic outcome.

    Measured: 12 months

  16. 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).

    Measured: 12 months

  17. MAST Test

    This is a neurological physical examination.

    Measured: 12 months

  18. MoCA Test

    This is a neurological physical examination.

    Measured: 12 months

  19. Functional Ambulation Categories

    This is a neurological physical examination.

    Measured: 12 months

  20. 10 Meters Walking Test

    This is a neurological physical examination. The variable will collected in m/sg.

    Measured: 12 months

  21. 6 Minutes Walking Test

    This is a neurological physical examination. The variable will collected in metres.

    Measured: 12 months

  22. Berg Balance Scale

    This is a neurological physical examination.

    Measured: 12 months

  23. Frenchay Arm Test

    This is a neurological physical examination.

    Measured: 12 months

  24. 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).

    Measured: 12 months

  25. 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.

    Measured: 12 months

  26. Line Bisection Test

    This is a neurological physical examination.

    Measured: 12 months

  27. Disphagia

    This is a neurological physical examination.

    Measured: 12 months

  28. Campimetry

    This is a neurological physical examination.

    Measured: 12 months

  29. Analogic Visual Scale

    This is a neurological physical examination.

    Measured: 12 months

  30. Analgesic Treatments

    This is a neurological physical examination.

    Measured: 12 months

  31. Golberg Scale

    This is a cardiovascular risk factor. To messure depression and anxiety.

    Measured: 12 months

  32. Weight

    This is a cardiovascular risk factor. In kg

    Measured: 12 months

  33. Height

    This is a cardiovascular risk factor. In meter

    Measured: 12 months

  34. BMI

    This is a cardiovascular risk factor.

    Measured: 12 months

  35. Waist Size

    This is a cardiovascular risk factor.

    Measured: 12 months

  36. Waist to Hip Ratio

    This is a cardiovascular risk factor.

    Measured: 12 months

  37. Blood Pressure

    This is a cardiovascular risk factor. In mmHg

    Measured: 12 months

  38. Heart Rate

    This is a cardiovascular risk factor.

    Measured: 12 months

  39. Glycaemia

    This is a cardiovascular risk factor.

    Measured: 12 months

  40. Health Literacy Test

    This is for measure the health literacy of the patient.

    Measured: 12 months

  41. Mediterranean Diet Assessment Test

    This is for measure the life style of the patient.

    Measured: 12 months

  42. Physical Activity

    This is for measure the life style of the patient.

    Measured: 12 months

  43. Toxic Consumption

    This is for measure the life style of the patient.

    Measured: 12 months

  44. Total Cholesterol

    This is a blood test for measure the lipidic profile of the patient.

    Measured: 12 months

  45. HDL

    This is a blood test for measure the lipidic profile of the patient.

    Measured: 12 months

  46. LDL

    This is a blood test for measure the lipidic profile of the patient.

    Measured: 12 months

  47. Proteins

    This is a blood test of the patient.

    Measured: 12 months

  48. Albumin

    This is a blood test of the patient.

    Measured: 12 months

  49. HbA1c

    This is a blood test of the patient.

    Measured: 12 months

  50. Apoprotein B

    This is a blood test of the patient.

    Measured: 12 months

  51. Apoportein A1

    This is a blood test of the patient.

    Measured: 12 months

  52. Lawton Index

    This is to messure the activities of daily living of the patient.

    Measured: 12 months

  53. SF-36

    This is to messure the quality of life of the patient.

    Measured: 12 months

  54. SIS

    This is to messure the quality of life of the patient.

    Measured: 12 months

  55. Stroke Self Management Questionary

    This is to messure the self management satisfaction of the patient.

    Measured: 12 months

  56. Stroke Management Questionary

    This is to messure the self management satisfaction of the patient.

    Measured: 12 months

  57. Satisfaction Questionary

    This is to messure the self management satisfaction of the patient.

    Measured: 12 months

  58. Post Stroke Checklist

    This is to messure the adherence to the treatment of the patient.

    Measured: 12 months

  59. Pharmacological Accountability

    This is to messure the adherence to the treatment of the patient.

    Measured: 12 months

  60. Non Pharmacological Accountability

    This is to messure the adherence to the treatment of the patient.

    Measured: 12 months

  61. Stroke Recurrences

    This is to messure the complications of the patient.

    Measured: 12 months

  62. Number of Readmissions

    This is to messure the complications of the patient.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2018
  2. Study start27 Apr 2018
  3. Primary completion1 Feb 2019 (estimated)
  4. Study completion1 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580642
Sponsor's protocol ID
STARR
Acronym
STARR
Status last verified
Jul 2018
First submitted
22 Dec 2017
Last updated
24 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing eHealth Technologies in people with Telerehabilitation and Stroke, run by Biobizkaia Health Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leire Ortiz (+ 34 685779523, LEIRE.ORTIZFERNANDEZ@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03580642.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.

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