ThalassemiaTHALEANCT06800495
Development of THALEA Kit and Its Impact on Knowledge, Attitude, and Intention for Premarital Thalassemia Screening
A study testing THALEA (Thalassemia Education and Awareness) Kit and Basic thalassemia and family health education in people with Thalassemia, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
Thalassemia, a common genetic disease, is often overlooked compared to infectious diseases like HIV, despite its significant effects for families planning to have children. Thalassemia carriers are frequently asymptomatic, but when two carriers marry, there is a 25% chance of having a child with a severe form of the… Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Thalassemia
- What is being tested?
- THALEA (Thalassemia Education and Awareness) Kit and Basic thalassemia and family health education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Malaysians.
- Fourth form students.
- Able to read and write in either Malay or the English language.
Who cannot join
- Those who have previously undergone thalassemia screening
- Identified as thalassemia carriers
- Without parental consent or assent
- Has first-degree relatives diagnosed with thalassemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of THALEA (Thalassemia Education and Awareness) Kit and a Cluster Randomised Control Trial to Evaluate Its Effectiveness on Knowledge, Attitude, and Intention Regarding Premarital Thalassemia Screening Among Private Secondary School Students of Klang Valley, Malaysia
Thalassemia, a common genetic disease, is often overlooked compared to infectious diseases like HIV, despite its significant effects for families planning to have children. Thalassemia carriers are frequently asymptomatic, but when two carriers marry, there is a 25% chance of having a child with a severe form of the disease. Although screening programs exist, the number of symptomatic thalassemia major continues to increase, and current treatments are primarily symptomatic, merely prolonging survival rather than curing it.
In Malaysia, while HIV testing before marriage is mandatory, thalassemia screening is not. Presently, thalassemia screening and awareness programs are offered to fourth-form students in government schools only. Hence, there is a need to complement existing national screening efforts by creating a standardized thalassemia awareness program that can be effectively implemented across diverse educational institutions.
Read more
Our main objective is to develop and validate the THALEA (Thalassemia education and awareness) kit and evaluate its effectiveness among secondary school students in Klang Valley, Malaysia. We hope that with this intervention, high school students are be able to increase their awareness and knowledge, instil a positive attitude and have that intention to do a pre-marital thalassemia screening at any healthcare facility in our country. This can facilitate early detection and timely counselling to reduce the risk of having children with severe thalassemia.
Delivery of the intervention:
- Schools will be approached by letter, followed by a phone call and a visit. ii. Consent forms will be given for parents to sign. iii. All fourth form students at the school will be invited to participate in the study, excluding those who meet the exclusion criteria. iv. THALEA will be delivered by a face-to-face method between the main researcher and the students.
- Frequency of delivery - one time only vi. Duration of intervention - 2-3 hours. vii. The intervention group will receive THALEA along with a basic family health education. THALEA's session comprises a face-to-face verbal presentation facilitated by the primary researcher, featuring an engaging interactive seminar and on-screen games. Following this, participants will be presented with 3-5-minute videos and pictorial materials, fostering two-way discussions. Subsequently, a softcopy of the THALEA kit will be distributed to the teacher in charge via email or WhatsApp after the seminar for further dissemination. The students will receive THALEA's brochures. viii. The comparison group will only receive a basic family health education in which it is the usual family health education given by the MOH, usually delivered by a medical officer, to fourth form students at government schools prior to the thalassemia screening programme. It will consist of a delivery of a PowerPoint presentation and videos, that will be obtained from government public health clinics in Klang Valley.
We will use a self-administered questionnaire designed and validated to assess knowledge, attitude, and intention regarding premarital thalassemia screening among youths at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and 2 weeks post assessment (t2)
- Conditions
- Thalassemia
- Being tested
- THALEA (Thalassemia Education and Awareness) Kit, Basic thalassemia and family health education
- Keywords
- Thalassemia, Educational intervention, secondary school students, THALEA, Thalassemia awareness, Premarital Thalassemia screening, Thalassemia education, thalassemia educational intervention, high school students, Malaysia, knowledge, attitude and intention
- Medical subject headings
- Thalassemia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THALEA (Thalassemia Education and Awareness) KitBehavioural
Also called THALEA
By using the opinions obtained by the experts, THALEA's content will then be designed using the Theory of Planned Behaviour (TPB) by Ajzen and Fishbein.
Development of THALEA:
- Language: Malay and English.
- Contents of the THALEA kit: i. PowerPoint or Canva presentations with discussion prompts (softcopy form) ii. Links/joining codes to free educational game platforms such as Kahoot or Quizziz iii. Videos - convey messages on thalassemia awareness and screening importance. iv. Illustrated guides/brochures - to provide step-by-step tutorials on how to get thalassemia screening in both the public and private healthcare.
- Developer would be the main researcher with aid from: i. Illustrator ii. Video graphic designer iii. Influencers
- Delivery of THALEA to students by: i. Medical personnel
Basic thalassemia and family health educationBehavioural
They are basic family health education in which it is the usual family health education given by the MOH, usually delivered by a medical officer, to fourth form students at government schools prior to the thalassemia screening programme. It will consist of a delivery of a PowerPoint presentation and videos, that will be obtained from government public health clinics in Klang Valley.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | vii. The intervention group will receive THALEA along with a basic family health education. THALEA's session comprises a face-to-face verbal presentation facilitated by the primary researcher, featuring an engaging interactive seminar and on-screen games. Following this, participants will be presented with 3-5-minute videos and pictorial materials, fostering two-way discussions. Subsequently, a softcopy of the THALEA kit will be distributed to the teacher in charge via email or WhatsApp after the seminar for further dissemination. The students will receive THALEA's brochures. Receives: Behavioral: THALEA (Thalassemia Education and Awareness) Kit |
| Comparison arm | Active comparator | viii. The comparison group will only receive a basic family health education in which it is the usual family health education given by the MOH, usually delivered by a medical officer, to fourth form students at government schools prior to the thalassemia screening programme. It will consist of a delivery of a PowerPoint presentation and videos, that will be obtained from government public health clinics in Klang Valley. Receives: Behavioral: Basic thalassemia and family health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and attitude score
Knowledge and attitude score will be calculated by using the filled in self-administered questionnaire designed and validated to assess knowledge, attitude, and intention regarding premarital thalassemia screening among youths
Measured: i. All students will be given 5 minutes to fill in their demographic information ii. Then 10 to 15 minutes will be given to answer the questionnaire at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and
Secondary outcomes (1)
Intention regarding premarital thalassemia screening
This will also be calculated using the same questionnaire.
Measured: i. All students will be given 5 minutes to fill in their demographic information ii. Then 10 to 15 minutes will be given to answer the questionnaire at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Oct 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- THALEA (Thalassemia education and awareness) Kit is an educational intervention for secondary school students that is developed according to the theory of planned behaviour. It is to be delivered to high school students by a medical practitioner
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisarah binti Noor Anwar, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800495
- Sponsor's protocol ID
- THALEA
- Other IDs
- Other funds
- Acronym
- THALEA
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of THALEA (Thalassemia Education and Awareness) Kit and a Cluster Randomised Control Trial to Evaluate Its Effectiveness on Knowledge, Attitude, and Intention Regarding Premarital Thalassemia Screening Among Private Secondary School Students of Klang Valley, Malaysia
- ClinicalTrials.gov ID
- NCT06800495
- Acronym / sponsor ID
- THALEA / THALEA
- Conditions
- Thalassemia
- Keywords
- Thalassemia, Educational intervention, secondary school students, THALEA, Thalassemia awareness, Premarital Thalassemia screening, Thalassemia education, thalassemia educational intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jan 2025 (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.
Thalassemia, a common genetic disease, is often overlooked compared to infectious diseases like HIV, despite its significant effects for families planning to have children. Thalassemia carriers are frequently asymptomatic, but when two carriers marry, there is a 25% chance of having a child with a severe form of the disease. Although screening programs exist, the number of symptomatic thalassemia major continues to increase, and current treatments are primarily symptomatic, merely prolonging survival rather than curing it.
In Malaysia, while HIV testing before marriage is mandatory, thalassemia screening is not. Presently, thalassemia screening and awareness programs are offered to fourth-form students in government schools only. Hence, there is a need to complement existing national screening efforts by creating a standardized thalassemia awareness program that can be effectively implemented across diverse educational institutions.
Our main objective is to develop and validate the THALEA (Thalassemia education and awareness) kit and evaluate its effectiveness among secondary school students in Klang Valley, Malaysia. We hope that with this intervention, high school students are be able to increase their awareness and knowledge, instil a positive attitude and have that intention to do a pre-marital thalassemia screening at any healthcare facility in our country. This can facilitate early detection and timely counselling to reduce the risk of having children with severe thalassemia.
Delivery of the intervention:
- Schools will be approached by letter, followed by a phone call and a visit. ii. Consent forms will be given for parents to sign. iii. All fourth form students at the school will be invited to participate in the study, excluding those who meet the exclusion criteria. iv. THALEA will be delivered by a face-to-face method between the main researcher and the students.
- Frequency of delivery - one time only vi. Duration of intervention - 2-3 hours. vii. The intervention group will receive THALEA along with a basic family health education. THALEA's session comprises a face-to-face verbal presentation facilitated by the primary researcher, featuring an engaging interactive seminar and on-screen games. Following this, participants will be presented with 3-5-minute videos and pictorial materials, fostering two-way discussions. Subsequently, a softcopy of the THALEA kit will be distributed to the teacher in charge via email or WhatsApp after the seminar for further dissemination. The students will receive THALEA's brochures. viii. The comparison group will only receive a basic family health education in which it is the usual family health education given by the MOH, usually delivered by a medical officer, to fourth form students at government schools prior to the thalassemia screening programme. It will consist of a delivery of a PowerPoint presentation and videos, that will be obtained from government public health clinics in Klang Valley.
We will use a self-administered questionnaire designed and validated to assess knowledge, attitude, and intention regarding premarital thalassemia screening among youths at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and 2 weeks post assessment (t2)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- THALEA (Thalassemia education and awareness) Kit is an educational intervention for secondary school students that is developed according to the theory of planned behaviour. It is to be delivered to high school students by a medical practitioner
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: THALEA (Thalassemia Education and Awareness) Kitvii. The intervention group will receive THALEA along with a basic family health education. THALEA's session comprises a face-to-face verbal presentation facilitated by the primary researcher, featuring an engaging interactive seminar and on-screen games. Following this, participants will be presented with 3-5-minute videos and pictorial materials, fostering two-way discussions. Subsequently, a softcopy of the THALEA kit will be distributed to the teacher in charge via email or WhatsApp after the seminar for further dissemination. The students will receive THALEA's brochures. |
| Comparison arm | Active comparator | Behavioral: Basic thalassemia and family health educationviii. The comparison group will only receive a basic family health education in which it is the usual family health education given by the MOH, usually delivered by a medical officer, to fourth form students at government schools prior to the thalassemia screening programme. It will consist of a delivery of a PowerPoint presentation and videos, that will be obtained from government public health clinics in Klang Valley. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Malaysians.
- Fourth form students.
- Able to read and write in either Malay or the English language.
Key exclusion criteria (4 listed)
- Those who have previously undergone thalassemia screening
- Identified as thalassemia carriers
- Without parental consent or assent
- Has first-degree relatives diagnosed with thalassemia
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 |
|---|---|---|
| THALEA (Thalassemia Education and Awareness) KitAlso: THALEABy using the opinions obtained by the experts, THALEA's content will then be designed using the Theory of Planned Behaviour (TPB) by Ajzen and Fishbein. Development of THALEA: • Language: Malay and English. • Contents of the THALEA kit: i. PowerPoint or Canva presentations with discussion prompts (softcopy form) ii. Links/joining codes to free educational game platforms such as Kahoot or Quizziz iii. Videos - convey messages on thalassemia awareness and screening importance. iv. Illustrated guides/brochures - to provide step-by-step tutorials on how to get thalassemia screening in both the public and private healthcare. • Developer would be the main researcher with aid from: i. Illustrator ii. Video graphic designer iii. Influencers • Delivery of THALEA to students by: i. Medical personnel | Behavioural | Intervention arm |
| Basic thalassemia and family health educationThey are basic family health education in which it is the usual family health education given by the MOH, usually delivered by a medical officer, to fourth form students at government schools prior to the thalassemia screening programme. It will consist of a delivery of a PowerPoint presentation and videos, that will be obtained from government public health clinics in Klang Valley. | Behavioural | Comparison arm |
Primary outcome
Knowledge and attitude score
Time frame: i. All students will be given 5 minutes to fill in their demographic information ii. Then 10 to 15 minutes will be given to answer the questionnaire at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and
Knowledge and attitude score will be calculated by using the filled in self-administered questionnaire designed and validated to assess knowledge, attitude, and intention regarding premarital thalassemia screening among youths
1 secondary outcome
Intention regarding premarital thalassemia screening
Time frame: i. All students will be given 5 minutes to fill in their demographic information ii. Then 10 to 15 minutes will be given to answer the questionnaire at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
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A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
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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 THALEA (Thalassemia Education and Awareness) Kit and Basic thalassemia and family health education in people with Thalassemia, run by Universiti Teknologi Mara 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 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Knowledge and attitude score (time frame: i. All students will be given 5 minutes to fill in their demographic information ii. Then 10 to 15 minutes will be given to answer the questionnaire at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and). 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 30 Jan 2025.