Stroke, AcuteNCT03391713
The Effectiveness of Waiting Room Posters for Stroke Education
A study testing Poster in people with Stroke, Acute, run by University of Malaya at 1 site in Malaysia.
Trial summary
The purpose of this study is to determine the effectiveness of posters in improving patient awareness and knowledge of the signs and symptoms of stroke. The control group study will be conducted in the first two weeks. Subsequently, the intervention arm will occur in the subsequent two weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Poster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,064 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Mar 2018to 30 Mar 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult age more than 18 years old and above
- Able to understand Malay
- Able to provide informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Waiting Room Posters in Improving Awareness and Knowledge of the Signs and Symptoms of Stroke
The purpose of this study is to determine the effectiveness of posters in improving patient awareness and knowledge of the signs and symptoms of stroke. The control group study will be conducted in the first two weeks. Subsequently, the intervention arm will occur in the subsequent two weeks.
Read the detailed description
Stroke is a major health problem and a known cause of death and disability worldwide. In Malaysia, stroke is known to be top five causes of death and top ten causes of hospitalization Malaysia. Ischemic stroke accounts for more than 95% of all stroke cases (1). A recent study done in Malaysia showed that only 26% of patients with stroke symptoms presented to the hospital within 3 hours. One of the reasons was patients did not perceive the symptoms of stroke as being that of a serious illness (2). One of the modalities to raise awareness of stroke is through an educational poster. Posters in the waiting room can increase awareness of health promotion issues (3). Therefore, by placing poster regarding sign and symptoms of stroke in the waiting room in a government clinic, can increase awareness of early presentation of stroke.
- Conditions
- Stroke, Acute
- Being tested
- Poster
- Keywords
- awareness, poster, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosterBehavioural
The poster includes the FAST symptoms but translated to the Malay language (Ce.P.A.T) Cakap tak jelas (slurred speech - Speech slurring) Perubahan muka (face changes - Face drooping) Anggota lemah (weak limbs - Arm weakness) Terus ke Hospital (straight to the hospital - Time to call 911
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No exposure to waiting room posters |
| Intervention | Active comparator | During the second half of the study (two weeks), there will be an education poster in the waiting room of the clinic, fashioned after the Face, Arms, Speech, Time (FAST) poster developed by the American Heart Association (AHA), but in Malay. Receives: Behavioral: Poster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of the signs and symptoms of stroke
Participants awareness of the signs and symptoms of stroke as assessed by a questionnaire. For the symptoms, patients are scored from 0-7, according to each correct answer given.
For the action taken, and the time frame, a score of either 0 or 1 is given, 1 being the right answer given.
A higher score would indicate a better awareness of the signs and symptoms of stroke.
Measured: Within 24 hours
Secondary outcomes (1)
Improvement in the knowledge of the need for a quick transfer to the hospital
Knowledge of the need for a quick transfer to the hospital as assessed by a questionnaire. For the symptoms, patients are scored from 0-7, according to each correct answer given.
For the action taken, and the time frame, a score of either 0 or 1 is given, 1 being the right answer given.
A higher score would indicate a better awareness of the signs and symptoms of stroke.
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start19 Mar 2018
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Professor Su May Liew, University of Malaya
- Investigators
- Su May Liew, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391713
- Sponsor's protocol ID
- RU009-2017J
- Status last verified
- May 2018
- First submitted
- 20 Dec 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheah WK, Hor CP, Zariah AA, Looi I. A Review of Stroke Research in Malaysia from 2000 - 2014. Med J Malaysia. 2016 Jun;71(Suppl 1):58-69.
PubMed 27801388Factors associated with delay in seeking treatment by patients with acute stroke: The National Neurology Registry (NNeuR) of Malaysia . Malinee Neelamegam1, Sharad Malavade1, Irene Looi2, Norsima Nazifah Sidek3, Zariah Abdul Aziz3. 2014
Ward K, Hawthorne K. Do patients read health promotion posters in the waiting room? A study in one general practice. Br J Gen Pract. 1994 Dec;44(389):583-5.
PubMed 7748670
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Waiting Room Posters in Improving Awareness and Knowledge of the Signs and Symptoms of Stroke
- ClinicalTrials.gov ID
- NCT03391713
- Acronym / sponsor ID
- RU009-2017J
- Conditions
- Stroke, Acute
- Keywords
- awareness, poster, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,064 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 5 Jan 2018 (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 determine the effectiveness of posters in improving patient awareness and knowledge of the signs and symptoms of stroke. The control group study will be conducted in the first two weeks. Subsequently, the intervention arm will occur in the subsequent two weeks.
Detailed description
Stroke is a major health problem and a known cause of death and disability worldwide. In Malaysia, stroke is known to be top five causes of death and top ten causes of hospitalization Malaysia. Ischemic stroke accounts for more than 95% of all stroke cases (1). A recent study done in Malaysia showed that only 26% of patients with stroke symptoms presented to the hospital within 3 hours. One of the reasons was patients did not perceive the symptoms of stroke as being that of a serious illness (2). One of the modalities to raise awareness of stroke is through an educational poster. Posters in the waiting room can increase awareness of health promotion issues (3). Therefore, by placing poster regarding sign and symptoms of stroke in the waiting room in a government clinic, can increase awareness of early presentation of stroke.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No exposure to waiting room posters |
| Intervention | Active comparator | Behavioral: PosterDuring the second half of the study (two weeks), there will be an education poster in the waiting room of the clinic, fashioned after the Face, Arms, Speech, Time (FAST) poster developed by the American Heart Association (AHA), but in Malay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult age more than 18 years old and above
- Able to understand Malay
- Able to provide informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| PosterThe poster includes the FAST symptoms but translated to the Malay language (Ce.P.A.T) Cakap tak jelas (slurred speech - Speech slurring) Perubahan muka (face changes - Face drooping) Anggota lemah (weak limbs - Arm weakness) Terus ke Hospital (straight to the hospital - Time to call 911 | Behavioural | Intervention |
Primary outcome
Awareness of the signs and symptoms of stroke
Time frame: Within 24 hours
Participants awareness of the signs and symptoms of stroke as assessed by a questionnaire. For the symptoms, patients are scored from 0-7, according to each correct answer given. For the action taken, and the time frame, a score of either 0 or 1 is given, 1 being the right answer given. A higher score would indicate a better awareness of the signs and symptoms of stroke.
1 secondary outcome
Improvement in the knowledge of the need for a quick transfer to the hospital
Time frame: Within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Background: PubMed 27801388Cheah WK, Hor CP, Zariah AA, Looi I. A Review of Stroke Research in Malaysia from 2000 - 2014. Med J Malaysia. 2016 Jun;71(Suppl 1):58-69.
- BackgroundFactors associated with delay in seeking treatment by patients with acute stroke: The National Neurology Registry (NNeuR) of Malaysia . Malinee Neelamegam1, Sharad Malavade1, Irene Looi2, Norsima Nazifah Sidek3, Zariah Abdul Aziz3. 2014
- Background: PubMed 7748670Ward K, Hawthorne K. Do patients read health promotion posters in the waiting room? A study in one general practice. Br J Gen Pract. 1994 Dec;44(389):583-5.
- Individual participant dataSharing planned: No
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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.
Su May Liew principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poster in people with Stroke, Acute, run by University of Malaya at 1 site in Malaysia.
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 1 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 22 May 2018. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Awareness of the signs and symptoms of stroke (time frame: Within 24 hours). 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 NCT03391713, which also lists 3 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 22 May 2018.