StrokeNCT05110105
Exploring the Effect of Interactive Board Game Health Education on Improving Stroke Knowledge and Health Literacy in Community-Dwelling Adults
A study testing Interactive board game health education and Conventional health education in people with Stroke, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the effectiveness between interactive board game health education and conventional health education in improving community-dwelling adults' stroke knowledge and self-reported stroke health literacy, including risk factors, symptoms, acute management of stroke, and 6 aspects of… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Interactive board game health education and Conventional health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Nov 2021to Nov 2023
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 years old or above.
- Cases with sanity and ability to communicate in Chinese or Taiwanese.
- No oral difficulties in daily life, able to fully express research-relevant narratives and readings.
Who cannot join
- Patients with a history of stroke diagnosed by a physician.
- Non-Republic of China (Taiwan) nationality.
- Worked as a medical staff in the past, in the fields of medical care or health educator.
- Those who cannot complete the assessment according to the guidance of the assessor.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the effectiveness between interactive board game health education and conventional health education in improving community-dwelling adults' stroke knowledge and self-reported stroke health literacy, including risk factors, symptoms, acute management of stroke, and 6 aspects of self-reported stroke health literacy. The intervention group will receive an interactive board game in a group (2~6 individuals), while the control group was assigned to read the health education flier and watching the stroke prevention video. The follow-up period was set to be four weeks after the intervention, both control group, and intervention group.
Read the detailed description
Stroke is a major health problem and a known cause of death and disability. Approximately 13 million people suffered from stroke worldwide annually and it ranks fourth among the top 10 causes of death in Taiwan. In a recent survey of Taiwanese citizens on the World Stroke Day event (New Taipei City) in 2012, the public's stroke literacy was low, only 5.71% of them can reach "good stroke literacy". Generally, stroke education was mostly implemented in a one-way lecture way. Therefore, instead of one-way style health education, the investigators assume that interactive board games can increase stroke knowledge, stroke literacy, and self-reported stroke health literacy of community-dwelling seniors.
- Conditions
- Stroke
- Being tested
- Interactive board game health education, Conventional health education
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive board game health educationBehavioural
The interactive board game includes risk factors, symptoms, and acute management of stroke. It's a card game combined with (1) addition and subtraction game (risk factors). (2) gestures game (symptoms) (3) matching game (acute management), but in traditional Chinese. The game was implemented in a group (2~6 individuals) for 40 minutes.
Conventional health educationBehavioural
The health education flier was made refer to medical institutions, e.g., hospitals or clinics, the stroke prevention video was collected from the internet. Participants were assigned to read the health education flier for 20 minutes. Then watch the stroke prevention video for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive interactive board game health education. Receives: Behavioral: Interactive board game health education |
| Control | Active comparator | Participants will receive conventional health education. Receives: Behavioral: Conventional health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Stroke Knowledge and Literacy right after the intervention.
Participants' stroke knowledge and literacy were assessed by a questionnaire. Good stroke literacy was determined according to fulfillment of the following criteria: (1) the brain was recognized as the main damaged organ; (2) at least five risk factors of stroke were identified; (3) more than five stroke symptoms were identified; and (4) in case of a stroke, the identified appropriate response was to call 119 immediately. For risk factors and symptoms, according to each correct answer given, a score of either 0 or 1 is given, 1 being the right answer given. A higher score would indicate a better knowledge of the risk factors and symptoms of stroke.
Measured: Right after the intervention
Change from Baseline Stroke Knowledge and Literacy at 4 weeks.
Participants' stroke knowledge and literacy were assessed by a questionnaire. Good stroke literacy was determined according to fulfillment of the following criteria: (1) the brain was recognized as the main damaged organ; (2) at least five risk factors of stroke were identified; (3) more than five stroke symptoms were identified; and (4) in case of a stroke, the identified appropriate response was to call 119 immediately. For risk factors and symptoms, according to each correct answer given, a score of either 0 or 1 is given, 1 being the right answer given. A higher score would indicate a better knowledge of the risk factors and symptoms of stroke.
Measured: 4 weeks after the intervention
Secondary outcomes (2)
Change from Baseline Self-reported Stroke Health Literacy right after the intervention.
Participants' self-reported stroke health literacy was assessed by a questionnaire. The questionnaire contains 6 aspects of stroke health literacy, including the ability to (1) obtain stroke health information; (2) understand written stroke health information; (3) understand oral stroke health information, (4) communicate and being interactive with stroke health information; (5) evaluate and judge stroke health information; (6) apply stroke health information for medical decision-making. A higher score would indicate a better self-reported stroke health literacy.
Measured: Right after the intervention
Change from Baseline Self-reported Stroke Health Literacy at 4 weeks.
Participants' self-reported stroke health literacy was assessed by a questionnaire. The questionnaire contains 6 aspects of stroke health literacy, including the ability to (1) obtain stroke health information; (2) understand written stroke health information; (3) understand oral stroke health information, (4) communicate and being interactive with stroke health information; (5) evaluate and judge stroke health information; (6) apply stroke health information for medical decision-making. A higher score would indicate a better self-reported stroke health literacy.
Measured: 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start8 Nov 2021
- Primary completion31 Jan 2022
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Fong Lin, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110105
- Sponsor's protocol ID
- N202108063
- Status last verified
- Apr 2023
- First submitted
- 13 Oct 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Interactive Board Game Health Education on Improving Stroke Knowledge and Health Literacy in Community-Dwelling Adults
- ClinicalTrials.gov ID
- NCT05110105
- Acronym / sponsor ID
- N202108063
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- Nov 2023 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the effectiveness between interactive board game health education and conventional health education in improving community-dwelling adults' stroke knowledge and self-reported stroke health literacy, including risk factors, symptoms, acute management of stroke, and 6 aspects of self-reported stroke health literacy. The intervention group will receive an interactive board game in a group (2~6 individuals), while the control group was assigned to read the health education flier and watching the stroke prevention video. The follow-up period was set to be four weeks after the intervention, both control group, and intervention group.
Detailed description
Stroke is a major health problem and a known cause of death and disability. Approximately 13 million people suffered from stroke worldwide annually and it ranks fourth among the top 10 causes of death in Taiwan. In a recent survey of Taiwanese citizens on the World Stroke Day event (New Taipei City) in 2012, the public's stroke literacy was low, only 5.71% of them can reach "good stroke literacy". Generally, stroke education was mostly implemented in a one-way lecture way. Therefore, instead of one-way style health education, the investigators assume that interactive board games can increase stroke knowledge, stroke literacy, and self-reported stroke health literacy of community-dwelling seniors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Interactive board game health educationParticipants will receive interactive board game health education. |
| Control | Active comparator | Behavioral: Conventional health educationParticipants will receive conventional health education. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 50 years old or above.
- Cases with sanity and ability to communicate in Chinese or Taiwanese.
- No oral difficulties in daily life, able to fully express research-relevant narratives and readings.
Key exclusion criteria (4 listed)
- Patients with a history of stroke diagnosed by a physician.
- Non-Republic of China (Taiwan) nationality.
- Worked as a medical staff in the past, in the fields of medical care or health educator.
- Those who cannot complete the assessment according to the guidance of the assessor.
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 |
|---|---|---|
| Interactive board game health educationThe interactive board game includes risk factors, symptoms, and acute management of stroke. It's a card game combined with (1) addition and subtraction game (risk factors). (2) gestures game (symptoms) (3) matching game (acute management), but in traditional Chinese. The game was implemented in a group (2~6 individuals) for 40 minutes. | Behavioural | Intervention |
| Conventional health educationThe health education flier was made refer to medical institutions, e.g., hospitals or clinics, the stroke prevention video was collected from the internet. Participants were assigned to read the health education flier for 20 minutes. Then watch the stroke prevention video for 20 minutes. | Behavioural | Control |
Primary outcome
Change from Baseline Stroke Knowledge and Literacy right after the intervention.
Time frame: Right after the intervention
Participants' stroke knowledge and literacy were assessed by a questionnaire. Good stroke literacy was determined according to fulfillment of the following criteria: (1) the brain was recognized as the main damaged organ; (2) at least five risk factors of stroke were identified; (3) more than five stroke symptoms were identified; and (4) in case of a stroke, the identified appropriate response was to call 119 immediately. For risk factors and symptoms, according to each correct answer given, a score of either 0 or 1 is given, 1 being the right answer given. A higher score would indicate a better knowledge of the risk factors and symptoms of stroke.
Change from Baseline Stroke Knowledge and Literacy at 4 weeks.
Time frame: 4 weeks after the intervention
Participants' stroke knowledge and literacy were assessed by a questionnaire. Good stroke literacy was determined according to fulfillment of the following criteria: (1) the brain was recognized as the main damaged organ; (2) at least five risk factors of stroke were identified; (3) more than five stroke symptoms were identified; and (4) in case of a stroke, the identified appropriate response was to call 119 immediately. For risk factors and symptoms, according to each correct answer given, a score of either 0 or 1 is given, 1 being the right answer given. A higher score would indicate a better knowledge of the risk factors and symptoms of stroke.
2 secondary outcomes
Change from Baseline Self-reported Stroke Health Literacy right after the intervention.
Time frame: Right after the intervention
Change from Baseline Self-reported Stroke Health Literacy at 4 weeks.
Time frame: 4 weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive board game health education and Conventional health education in people with Stroke, run by Taipei Medical University at 1 site in Taiwan.
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 3 inclusion and 4 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 12 Apr 2023. 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 Taiwan. 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?
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?
Change from Baseline Stroke Knowledge and Literacy right after the intervention. (time frame: Right after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.