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
Abstract
:1. Background
2. Methods/Design
2.1. Primary Objective
2.2. Secondary Objectives
- Self-management.
- Level of independence in the activities of daily living (ADL).
- Quality of life.
- Adherence to home-based rehabilitation and pharmacological and non-pharmacological treatment.
- Need for caregivers (family, care providers…).
- Recurrent stroke and the complications related to stroke.
- A number of hospital readmissions, emergency care, and outpatient visits to the hospital and primary care centers.
- Cost-effectiveness of the developed system.
- Accessibility of the developed system.
- Sustainability of the developed system.
- User’s satisfaction (by users, we mean stroke survivors, caregivers, and professionals using the developed system).
- Possible adverse events that the system can cause on the study participants.
2.3. Participants
- age 18 years to 80 years;
- having a diagnosis of first ischemic stroke within the past 6 months;
- hemiparesis with mild (91-99) or moderate (61-90) disability (Barthel Index, BI);
- with or without speech pathology but able to understand simple orders (Mississippi Aphasia Screening Test, >45);
- able to cope and to understand the guidelines to use the devices;
- the life expectancy of at least 12 months;
- no severe cognitive impairments (Montreal Cognitive Assessment, MoCA, >26);
- without medical comorbidities that could interfere with the home-rehabilitation program (for example, severe aortic stenosis, respiratory failure, severe osteoarthrosis);
- without socio-familiar dystocia (Gijon’s socio-familial evaluation scale (SFES) <14)
- without a basal functional situation >1 by a Modified Rankin Scale (MRS).
- medical comorbidities that could interfere with the home-rehabilitation program.
- refusal to sign the informed consent and participate in the study.
2.4. Study Design
- Wearables and connected objects: provide regular information about the evolution of certain risk factors (e.g., physical activity, blood pressure) without taking over users’ attention. The devices of the STARR system are composed of a tensiometer, a glucometer, a heart rate band, a balance, and a thermometer. All of them are commercial devices tested and with CE marking.
- A decision support system (DSS): implements personalized advice, guidance, and follow-up for daily life activities of the stroke survivors by analyzing the information coming from the wearables and the connected objects, a number of predictive models, and user profiles. The DDS has a system of alarms that will guide patients in making decisions, with recommendations, such as modifying life habits, consulting with their general practitioner, or going to the emergency department. These alarms are based on clinical practice guidelines with proven evidence in the management of patients with stroke. In addition, the responsible doctor of the study participant will have access to a control panel in the health system and a mobile application, where the alarms of the patients can be managed.
- Predictive models: will be populated by risk assessment information provided by validated predictive models calculating stroke risk. The risk estimation done by these models will be complemented by information from a model of human motion analysis and guidance developed during the project using Kinect’s cameras and a created program algorithm, which has been found to be very useful for assuring continued engagement in physical activities in clinical and home settings. It will also be supported by the implementation of models of behavior change to capture individual variations and attitude changes over time. The key requirement behind the implementation of these models is to motivate self-management by encouraging self-awareness and trend-awareness in lifestyle in the sub-acute and chronic phases of stroke.
- Self-management apps (DSS user interface): tools to inform and encourage stroke survivors to self-manage their condition. The STARR system will try to determine the user’s reason for non-adherence using a mobile phone app and an online lifestyle diary. The user will then automatically receive generated messages with persuasive, tailored content. The content will be different at different stages of the initiation and maintenance of health behavior.
- Serious games: promote physical activity and rehabilitation at home with suggested activities in serious games with a screen and a mini-bike.
2.5. Reason for Withdrawal From the Trial
- Death
- Loss of follow-up
- Severe disease of the principal caregiver
- Any other problems that, in the opinion of the research team, justify treatment withdrawal.
2.6. Recruitment
2.7. Protocol
2.8. Control Group
2.9. Intervention Group
2.10. Outcome Measures
- -
- Physical function (PF) assessed by the modified BI and Lawton index.
- -
- Risk factor reduction (blood pressure, analytical profile -glycemia, HbA1c, lipids, weight, heart rate control, medication compliance).
- -
- Self-management behaviors by self-reported information on lifestyles: diet assessed by the Mediterranean diet assessment tool, exercise assessed by tracking with the wearables, smoking, and alcohol consumption.
- -
- Healthcare resource utilization by the information available in the public health system in Osakidetza, Cruces university hospital.
- -
- Knowledge of condition to assess whether there is a relationship between health literacy and control of cardiovascular risk factors, number of complications, number of recurrences, low adherence to pharmacological and non-pharmacological treatment, and self-management behaviors.
- -
- Mood and social isolation by Goldberg scale that measures anxiety and depression.
- -
- Stroke Self-management questionnaire (SSMQ).
2.11. Safety
- causes the death of the patient
- threatens the life of the patient
- requires hospitalization or prolongation of patient hospitalization
- causes disability or permanent or major disability
- results in a congenital anomaly or malformation
2.12. Follow-up Period
2.13. Sample Size
2.14. Statistical Analysis
2.15. Quality Control and Assurance
- (a)
- the physical or psychological integrity or safety of patients during the trial, or
- (b)
- the values of the study. The study sponsor will be contacted as soon as possible. In any case, all violations will be notified to the relevant authorities in accordance with current legislation.
2.16. Limitations of the Study
3. Discussion
Author Contributions
Funding
Conflicts of Interest
Ethics Approval and Consent to Participate
Abbreviations
STARR | The Decision Support and self-management system for stroke survivors |
DSS | Decision Support System |
BI | Barthel Index |
MoCA | Montreal Cognitive Assessment |
SFES | Gijon’s Socio-Familial Evaluation Scale |
MRS | Modified Rankin Scale |
RCT | Research Clinical Trial |
RMD | Rehabilitation Medical Doctor |
PF | Physical Function |
SSMQ | Stroke Self-Management Questionnaire |
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Stroke Survivors | Variables/Scales | Event Visit (a) Month 0 | Baseline Visit (b) Month 6 | First Visit (c) Month 9 | Final Visit (d) Month 12 |
---|---|---|---|---|---|
Inclusion | Age | x | x | ||
Stroke characteristics and type | x | x | |||
Modified Barthel Index | x | x | x | ||
Modified Rankin Scale | x | x | x | ||
Mississippi Aphasia Screening Test [MAST] | x | x | x | ||
Montreal Cognitive Assessment [MoCA] | x | x | x | ||
Gijon’s social-familial evaluation scale | x | x | |||
Comorbidities | x | x | |||
Charlson Comorbidity Index | x | x | |||
Socio Demographic | Gender, ethnic group, deprivation index, hand dominance, education level, type of job, hobbies | x | x | ||
Clinical/ Neurological | Cardiovascular risk factors | x | x | x | x |
Neurological physical examination: Medical Research Council Scale [MRC] | x | x | x | x | |
Mississippi Aphasia Screening Test [MAST] | x | x | x | ||
Montreal Cognitive Assessment [MoCA] | x | x | x | ||
Functional Ambulation Categories [FAC] | x | x | x | x | |
10 m walking test/6 min walking test | x | x | x | x | |
Berg Balance Scale [BBS] | x | x | x | x | |
Frenchay Arm Test [FAT] | x | x | x | x | |
Asworth Modified Scale for Spasticity | x | x | x | x | |
Fatigue Severity Scale [FSS], | x | x | x | x | |
Line Bisection Test | x | x | x | x | |
Disphagia Sensitivity Campimetry | x | x | x | x | |
Pain Analogic visual scale for pain Analgesic treatment consumption | x | x | x | x | |
Depression and Anxiety: Golberg Scale | x | x | x | x | |
Stress | x | x | x | x | |
Weight, Height, BMI, waist size, waist-to-hip ratio | x | x | x | x | |
Blood pressure, heart rate, glycemia | x | x | x | x | |
Need of upper limb orthoses, lower limb orthoses, and canes and wheelchair use in outdoor activities | x | x | x | x | |
Health Literacy | Test of Functional Health Literacy in Adults Stroke Patient Education Retention | x | x | x | |
Usability | System Usability Scale | x | x | ||
Life Style | Mediterranean Diet Assessment Tool Physical activity/Exercise Toxic consumption | x | x | x | x |
Blood Test | Lipidic profile (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), cholesterol), glycemia, proteins, albumin, HbA1c, Apoprotein B, and Apoprotein A1 | x | x | x | |
Activities of Daily Living | Modified Barthel Index (BI) Lawton Index | x x | x x | x x | |
Quality of life | SF-36 Stroke Impact Scale (SIS) | x x | x x | x x | |
Self-Management | The Southampton Stroke Self-Management Questionnaire (SSSMQ) | x | x | x | |
Satisfaction Questionnaire | x | x | |||
Quebec User Evaluation of Satisfaction with Assistive Technology | x | x | |||
Adherence | Post-stroke checklist | x | x | ||
Non-pharmacological | |||||
Pharmacological | x | x | |||
Complications | Stroke recurrences Number of readmissions Number of consultations to the emergency department Number of visits/telephone calls to a general doctor Number of visits to specialist Number of secondary complications due to stroke | x | x |
Caregivers | Variables/Scales | Event Visit | Baseline Visit | First Visit | Final Visit |
---|---|---|---|---|---|
Health Literacy | Test of Functional Health Literacy in Adults Stroke Patient Education Retention | x | x | x | |
Quality of Life | SF-36 | x | x | x | |
Burn-Out | Caregiver Strain Index | x | x | ||
Self-Management | Family needs of stroke patient questionnaire | x | x | x | |
Satisfaction Questionnaire | Satisfaction Questionnaire | x | x | ||
Usability | System Usability Scale | x | x |
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Ortiz-Fernández, L.; Sagastagoya Zabala, J.; Gutiérrez-Ruiz, A.; Imaz-Ayo, N.; Alava-Menica, A.; Arana-Arri, E. 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. Methods Protoc. 2019, 2, 50. https://doi.org/10.3390/mps2020050
Ortiz-Fernández L, Sagastagoya Zabala J, Gutiérrez-Ruiz A, Imaz-Ayo N, Alava-Menica A, Arana-Arri E. 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. Methods and Protocols. 2019; 2(2):50. https://doi.org/10.3390/mps2020050
Chicago/Turabian StyleOrtiz-Fernández, Leire, Joana Sagastagoya Zabala, Agustín Gutiérrez-Ruiz, Natale Imaz-Ayo, Ander Alava-Menica, and Eunate Arana-Arri. 2019. "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" Methods and Protocols 2, no. 2: 50. https://doi.org/10.3390/mps2020050