NCT06800495: THALEA

Development of THALEA Kit and Its Impact on Knowledge, Attitude, and Intention for Premarital Thalassemia Screening

Active, enrolled NA Last updated 30 January 2025

What this trial tests

NA trial testing THALEA (Thalassemia Education and Awareness) Kit in Thalassemia in 148 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 October 2024

Primary endpoint
31 October 2025

31 December 2025

Quick facts

Lead sponsor	Universiti Teknologi Mara
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	148
Start date	1 October 2024
Primary completion	31 October 2025
Estimated completion	31 December 2025
Sites	1 location across Malaysia

Drugs / interventions tested

• THALEA (Thalassemia Education and Awareness) Kit
• Basic thalassemia and family health education

Conditions studied

• Thalassemia — all drugs for Thalassemia →

Sponsor

Universiti Teknologi Mara

Who can join

Adults 15 to 17, any sex, with Thalassemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

i. 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.

v. 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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.