Health Education
Conditions
Brief summary
The aim of this study is to establish PAtient-Centered Computerized Educating System for Stroke (PACCESS) for patients with different demands and lack of knowledge.Those in the intervention group will receive the PACCESS and the control groups will receive traditional health education to test the effects of PACCESS in increasing clinical decision-making, health behavior, activities of daily living and knowledge of stroke, and health care quality.
Detailed description
To prevent recurrent stroke and improve the health-related quality of life (HRQOL) in patients with stroke, education regarding the risk factors of recurrent stroke is a crucial part of effective care for patients with stroke. The aim of this study was to develop an application capable of providing health education for recurrent-stroke prevention. We also examined the effectiveness of this app for improving stroke-related knowledge and HRQOL in patients with stroke.
Interventions
DEVICEsmart phone and pad
Smart phone and pad is the mobile include the smart phone and pad, that can download the APP from internet.
OTHERstroke-related health education manual
stroke-related health education manual is the manual mainly contained information regarding the prevention of stroke risk factors.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* first time diagnosis of stroke (International Classification of Diseases, ninth revision, clinical modification \[ICD-9\] codes) of cerebral hemorrhage (ICD-9, 431) or cerebral infarction (ICD 9, 434) * ability to follow instructions and complete the interviews * having a designated caregiver who agrees to participate in the survey * \>6 years of education * have smartphone or the other mobile device can download the APP from internet.
Exclusion criteria
* cognitive impairment (Mini-Mental State Examination (MMSE scores\<24) * having major mental diseases (i.e., depression, dementia, delirium, etc.) * the inability to read/answer questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Health Education Knowledge Questionnaire | 4 weeks | The stroke knowledge questionnaire is the primary outcome of this study. The questions are single-choice questions. The content of the questions are based on the stroke health education manual and adapted to APP format in this study. For the 12 risk factors, each risk factor was sorted out 3 questions. There are total of 36 (3x12 = 36) questions of stroke knowledge, a score of 1 for each question, the highest score of 3 for each risk factor, the highest score of 36 points and the lowest score of 0 point. The higher score represents the better outcome. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health-education App (1) assisting the subjects in installing the app onto their personal smartphones; (2) teaching the patients about the content of the app and explaining its method of operation. | 30 |
| Health Education Manuals (1) giving the stroke-related health education manuals to subjects; (2) teaching the patients about the content of the manual. | 33 |
| Total | 63 |
Baseline characteristics
| Characteristic | Health-education App | Total | Health Education Manuals |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 43 Participants | 23 Participants |
| Age, Continuous | 50.47 years STANDARD_DEVIATION 10.82 | 51.40 years STANDARD_DEVIATION 11.08 | 52.33 years STANDARD_DEVIATION 11.33 |
| Region of Enrollment Taiwan | 30 participants | 63 participants | 33 participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 11 Participants |
| Sex: Female, Male Male | 21 Participants | 43 Participants | 22 Participants |
| Stroke knowledge questionnaire | 26.23 participants STANDARD_DEVIATION 6.65 | 25.72 participants STANDARD_DEVIATION 6.1 | 25.21 participants STANDARD_DEVIATION 5.54 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 33 |
| other Total, other adverse events | 0 / 30 | 0 / 33 |
| serious Total, serious adverse events | 0 / 30 | 0 / 33 |
Outcome results
Primary
Stroke Health Education Knowledge Questionnaire
The stroke knowledge questionnaire is the primary outcome of this study. The questions are single-choice questions. The content of the questions are based on the stroke health education manual and adapted to APP format in this study. For the 12 risk factors, each risk factor was sorted out 3 questions. There are total of 36 (3x12 = 36) questions of stroke knowledge, a score of 1 for each question, the highest score of 3 for each risk factor, the highest score of 36 points and the lowest score of 0 point. The higher score represents the better outcome.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health-education App | Stroke Health Education Knowledge Questionnaire | 29.07 score on a scale | Standard Deviation 5.27 |
| Health Education Manuals | Stroke Health Education Knowledge Questionnaire | 28.00 score on a scale | Standard Deviation 5.46 |