Health EducationNCT02591511
Effects of Patient-centered Stroke Educating System: a Randomized Controlled Trial
A study testing smart phone and pad and stroke-related health education manual in people with Health Education, run by Taipei Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Education
- What is being tested?
- smart phone and pad and stroke-related health education manual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Effects of Health-education Application on Improving Stroke-related Knowledge and Health Related Quality of Life in Patients With Stroke: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Health Education
- Being tested
- smart phone and pad, stroke-related health education manual
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart phone and padDevice
Smart phone and pad is the mobile include the smart phone and pad, that can download the APP from internet.
stroke-related health education manualOther
stroke-related health education manual is the manual mainly contained information regarding the prevention of stroke risk factors.
| Study group | Role | What they receive |
|---|---|---|
| health-education app | Experimental | Smart phone and pad is a stroke-related health education app intervention group Receives: Device: smart phone and pad |
| health education manuals | Active comparator | stroke-related health education manual control group Receives: Other: stroke-related health education manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Hsuan Hou, PHD, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591511
- Sponsor's protocol ID
- Taipei Medical University
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2015
- Last updated
- 14 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082Kang YN, Shen HN, Lin CY, Elwyn G, Huang SC, Wu TF, Hou WH. Does a Mobile app improve patients' knowledge of stroke risk factors and health-related quality of life in patients with stroke? A randomized controlled trial. BMC Med Inform Decis Mak. 2019 Dec 21;19(1):282. doi: 10.1186/s12911-019-1000-z.
PubMed 31864348
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Health-education Application on Improving Stroke-related Knowledge and Health Related Quality of Life in Patients With Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02591511
- Acronym / sponsor ID
- Taipei Medical University
- Conditions
- Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Posted 14 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health-education app | Experimental | Device: smart phone and padSmart phone and pad is a stroke-related health education app intervention group |
| health education manuals | Active comparator | Other: stroke-related health education manualstroke-related health education manual control group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smart phone and padSmart phone and pad is the mobile include the smart phone and pad, that can download the APP from internet. | Device | health-education app |
| stroke-related health education manualstroke-related health education manual is the manual mainly contained information regarding the prevention of stroke risk factors. | Other | health education manuals |
Primary outcome
Stroke Health Education Knowledge Questionnaire
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Derived from this study: PubMed 31864348Kang YN, Shen HN, Lin CY, Elwyn G, Huang SC, Wu TF, Hou WH. Does a Mobile app improve patients' knowledge of stroke risk factors and health-related quality of life in patients with stroke? A randomized controlled trial. BMC Med Inform Decis Mak. 2019 Dec 21;19(1):282. doi: 10.1186/s12911-019-1000-z.
Related trials for Health Education
Not yet recruiting
The Effect of Health Belief Model-Based HPV Infection and Vaccination Education on University Students' Knowledge and Health Beliefs
Health Belief Model, Nursing Students
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
RecruitingObservational study
Artificial Intelligence for Automated Clinical Data Exploration From Electronic Medical Records (CardioMining-AI)
Artificial Intelligence, Machine Learning
Active, not recruiting
AI-Assisted Child Health Podcast Education for Nursing Students
Nursing Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Hsuan Hou, PHD study chair
Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing smart phone and pad and stroke-related health education manual in people with Health Education, run by Taipei Medical University.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Health Education Knowledge Questionnaire (time frame: 4 weeks). 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 NCT02591511, which also lists 2 linked publications.
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 14 Sep 2018.