Exploring the Effect of Interactive Board Game Health Education on Improving Stroke Knowledge and Health Literacy in Community-Dwelling Adults

April 11, 2023 updated by: Li-Fong Lin, Taipei Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Da-an Elderly Service and Day Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants will receive interactive board game health education.
Behavioral: Interactive board game health education
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.
Active Comparator: Control
Participants will receive conventional health education.
Behavioral: Conventional health education
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Right after the intervention
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.
4 weeks after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Self-reported Stroke Health Literacy right after the intervention.
Time Frame: 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.
Right after the intervention
Change from Baseline Self-reported Stroke Health Literacy at 4 weeks.
Time Frame: 4 weeks 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.
4 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N202108063

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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