Decision Support System for Stroke Survivors (STARR)

• ClinicalTrials.gov Identifier: NCT03580642
• Recruitment Status: Unknown
• First Posted: July 9, 2018
• Last Update Posted: July 24, 2018
• Sponsor: Biocruces Bizkaia Health Research Institute
• Information provided by (Responsible Party): Leire Ortiz Fernández, Biocruces Bizkaia Health Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Telerehabilitation; Stroke; Life Style	Device: eHealth Technologies	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: April 27, 2018
• Estimated Primary Completion Date: February 1, 2019
• Estimated Study Completion Date: December 1, 2019

Arms and Interventions

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.	Device: 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.
No Intervention: Control; Habitual treatment.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Age [ Time Frame: 12 months ]
   This an outcome to evaluate the eligibility of the patient. Age variable will be in years.
2. Stroke date [ Time Frame: 12 months ]
   This an outcome to evaluate the eligibility of the patient. This variable will be the patient stroke date.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

8. Charlson Comorbidity Index [ Time Frame: 12 months ]
   This an outcome to evaluate the eligibility of the patient.
9. Gender [ Time Frame: 12 months ]
   This is a socio demographic outcome. This outcome will be collected as Male or Female.
10. Ethnic group [ Time Frame: 12 months ]
    This is a socio demographic outcome.
11. Deprivation index [ Time Frame: 12 months ]
    This is a socio demographic outcome.
12. Hand dominance [ Time Frame: 12 months ]
    This is a socio demographic outcome. This outcome will be collected as right-handed and left-handed.
13. Education level [ Time Frame: 12 months ]
    This is a socio demographic outcome.
14. Type of profession [ Time Frame: 12 months ]
    This is a socio demographic outcome.
15. Hobbies [ Time Frame: 12 months ]
    This is a socio demographic outcome.
16. 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).
17. MAST Test [ Time Frame: 12 months ]
    This is a neurological physical examination.
18. MoCA Test [ Time Frame: 12 months ]
    This is a neurological physical examination.
19. Functional Ambulation Categories [ Time Frame: 12 months ]
    This is a neurological physical examination.
20. 10 Meters Walking Test [ Time Frame: 12 months ]
    This is a neurological physical examination. The variable will collected in m/sg.
21. 6 Minutes Walking Test [ Time Frame: 12 months ]
    This is a neurological physical examination. The variable will collected in metres.
22. Berg Balance Scale [ Time Frame: 12 months ]
    This is a neurological physical examination.
23. Frenchay Arm Test [ Time Frame: 12 months ]
    This is a neurological physical examination.
24. 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).
25. 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.
26. Line Bisection Test [ Time Frame: 12 months ]
    This is a neurological physical examination.
27. Disphagia [ Time Frame: 12 months ]
    This is a neurological physical examination.
28. Campimetry [ Time Frame: 12 months ]
    This is a neurological physical examination.
29. Analogic Visual Scale [ Time Frame: 12 months ]
    This is a neurological physical examination.
30. Analgesic Treatments [ Time Frame: 12 months ]
    This is a neurological physical examination.
31. Golberg Scale [ Time Frame: 12 months ]
    This is a cardiovascular risk factor. To messure depression and anxiety.
32. Weight [ Time Frame: 12 months ]
    This is a cardiovascular risk factor. In kg
33. Height [ Time Frame: 12 months ]
    This is a cardiovascular risk factor. In meter
34. BMI [ Time Frame: 12 months ]
    This is a cardiovascular risk factor.
35. Waist Size [ Time Frame: 12 months ]
    This is a cardiovascular risk factor.
36. Waist to Hip Ratio [ Time Frame: 12 months ]
    This is a cardiovascular risk factor.
37. Blood Pressure [ Time Frame: 12 months ]
    This is a cardiovascular risk factor. In mmHg
38. Heart Rate [ Time Frame: 12 months ]
    This is a cardiovascular risk factor.
39. Glycaemia [ Time Frame: 12 months ]
    This is a cardiovascular risk factor.
40. Health Literacy Test [ Time Frame: 12 months ]
    This is for measure the health literacy of the patient.
41. Mediterranean Diet Assessment Test [ Time Frame: 12 months ]
    This is for measure the life style of the patient.
42. Physical Activity [ Time Frame: 12 months ]
    This is for measure the life style of the patient.
43. Toxic Consumption [ Time Frame: 12 months ]
    This is for measure the life style of the patient.
44. Total Cholesterol [ Time Frame: 12 months ]
    This is a blood test for measure the lipidic profile of the patient.
45. HDL [ Time Frame: 12 months ]
    This is a blood test for measure the lipidic profile of the patient.
46. LDL [ Time Frame: 12 months ]
    This is a blood test for measure the lipidic profile of the patient.
47. Proteins [ Time Frame: 12 months ]
    This is a blood test of the patient.
48. Albumin [ Time Frame: 12 months ]
    This is a blood test of the patient.
49. HbA1c [ Time Frame: 12 months ]
    This is a blood test of the patient.
50. Apoprotein B [ Time Frame: 12 months ]
    This is a blood test of the patient.
51. Apoportein A1 [ Time Frame: 12 months ]
    This is a blood test of the patient.
52. Lawton Index [ Time Frame: 12 months ]
    This is to messure the activities of daily living of the patient.
53. SF-36 [ Time Frame: 12 months ]
    This is to messure the quality of life of the patient.
54. SIS [ Time Frame: 12 months ]
    This is to messure the quality of life of the patient.
55. Stroke Self Management Questionary [ Time Frame: 12 months ]
    This is to messure the self management satisfaction of the patient.
56. Stroke Management Questionary [ Time Frame: 12 months ]
    This is to messure the self management satisfaction of the patient.
57. Satisfaction Questionary [ Time Frame: 12 months ]
    This is to messure the self management satisfaction of the patient.
58. Post Stroke Checklist [ Time Frame: 12 months ]
    This is to messure the adherence to the treatment of the patient.
59. Pharmacological Accountability [ Time Frame: 12 months ]
    This is to messure the adherence to the treatment of the patient.
60. Non Pharmacological Accountability [ Time Frame: 12 months ]
    This is to messure the adherence to the treatment of the patient.
61. Stroke Recurrences [ Time Frame: 12 months ]
    This is to messure the complications of the patient.
62. Number of Readmissions [ Time Frame: 12 months ]
    This is to messure the complications of the patient.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Leire Ortiz; + 34 685779523; LEIRE.ORTIZFERNANDEZ@osakidetza.eus

Contact: Joana Sagastagoya; + 34 94 600 6000 ext 63 67; JOANA.SAGASTAGOYAZABALA@osakidetza.eus

Locations

Spain

Hospital Universitario Cruces; Recruiting

Barakaldo, Bizkaia, Spain, 48903

Contact: Leire Ortiz +34 685779523 LEIRE.ORTIZFERNANDEZ@osakidetza.eus

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

Sponsors and Collaborators

Biocruces Bizkaia Health Research Institute

More Information

• Responsible Party: Leire Ortiz Fernández, Principal Investigator, Biocruces Bizkaia Health Research Institute
• ClinicalTrials.gov Identifier: NCT03580642
• Other Study ID Numbers: STARR
• First Posted: July 9, 2018
• Last Update Posted: July 24, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases