ThalassemiaNCT04706585
Thalassemia Knowledge in Young People of Indonesia
An observational study of Thalassemia, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial summary
There is still an ongoing lack of awareness about thalassemia among Indonesians despite high disease prevalence, and this is associated with poor implementation of preventive and promotive measures. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Thalassemia
- How many people
- 1,010 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2021to 10 Oct 2021
- Phase
- Observational
- 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 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: In this study, we will ask young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in our online survey.
Who may be able to join
- Survey participants are based in Indonesia
- Survey participants are between the age of 15-24 and currently attending high school or university level education
- Survey participants include both thalassemia-affected patients and non-patients
- Survey participants have understood and given their consent for the research
Who cannot join
- Currently not studying/living in Indonesia
- Below the age of 15 or above 24
- No consent is given
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Fakultas Kedokteran Universitas Indonesia - Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
Mikhael Yosia, Dr., 081378778784, mikhael.yosia@gmail.com
About this study
Official title: Thalassemia in Indonesia: Current Knowledge, Attitude, and Practice Among Young People
There is still an ongoing lack of awareness about thalassemia among Indonesians despite high disease prevalence, and this is associated with poor implementation of preventive and promotive measures. Thalassemia experts argue that education and raising awareness about thalassemia must be done from an early age in order to relieve the heavy disease burden of thalassemia, especially in Indonesia as it is geographically located in the thalassemia belt. In spite of this, there has been limited research on public perception towards thalassemia in Indonesia, particularly among young people.
In this study, the researcher will ask young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in an online survey. The survey consists of questions about the participants' demographic information as well as their knowledge, attitude, and practice (KAP) scores towards thalassemia. The study is expected to run from December 2020 to March 2021, with the online survey distributed in January 2021. Data collection will immediately follow, and it will be analyzed using univariate, bivariate, and multivariate analysis using the appropriate statistical tests. The findings gathered from this study will be vital in providing new insight into how the youth sees thalassemia in Indonesia. Such public health information will prove to be important in designing successful thalassemia intervention and education programs for Indonesian youth.
Read the detailed description
Research concept
In this study, the researcher will ask young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in an online survey. The survey consists of questions about the participants' demographic information as well as their knowledge, attitude, and practice (KAP) scores towards thalassemia. The study is expected to run from December 2020 to March 2021, with the online survey distributed in January 2021. Data collection will immediately follow, and it will be analysed using univariate, bivariate, and multivariate analysis using the appropriate statistical tests.
Study design
To evaluate the knowledge, attitude, and practice of Indonesian youth, the study design used will be observational, cross-sectional. An online questionnaire developed by the research team along with several experts is expected to be disseminated to the target population in January 2021. In light of the ongoing pandemic, this is expected to be a nationwide study where most of the work is done via online methods.
Place and period of study
This study will be conducted via online survey due to the ongoing pandemic situation. The study is expected to run from December 2020 to March 2021.
- Conditions
- Thalassemia
- Keywords
- Thalassemia, Indonesia, Youth
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Youth | Young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in our online survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indonesian youth's level of knowledge on thalassemia
To determine the relationships among Indonesian youth's demographic, education and socioeconomic level to their knowledge of thalassemia via a validated self-developed questionnaire. Knowledge will be assessed through question of common knowledges surrounding thalassemia, a final score (out of 100) will be used as representation of knowledge level (0-25: poor, 25-50 moderate, 51-75 good, and 76-100 very good) will be evaluated after participants answer all the questions.
Measured: Baseline, pre-intervention
Indonesian youth's attitude towards thalassemia
To determine the relationships among Indonesian youth's demographic, education and socioeconomic level to their attitude towards thalassemia via a validated self-developed questionnaire. (using a Likert scale of 1 to 4 - with 1 being "strongly agree" and 4 "strongly disagree")
Measured: Baseline, pre-intervention
Indonesian youth's practice towards thalassemia
To determine the relationships among Indonesian youth's demographic, education and socioeconomic level to their action and practice towards prevention of thalassemia via a validated self-developed questionnaire. (using a Likert scale of 1 to 4 - with 1 being "strongly agree" and 4 "strongly disagree")
Measured: Baseline, pre-intervention
Secondary outcomes (1)
Willingness to undergo thalassemia screening
To determine Indonesian youth's willingness (using a Likert scale of 1 to 4 - with 1 being "strongly agree" and 4 "strongly disagree") to undergo thalassemia screening independently
Measured: Baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion10 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pustika A Wahidiyat, Professor., Principal investigator, Fakultas Kedokteran Universitas IndonesiaMikhael Yosia, Dr., Principal investigator, Fakultas Kedokteran Universitas IndonesiaEdward C Yo, Study director, Fakultas Kedokteran Universitas IndonesiaMuhammad M Wildani, Study chair, Fakultas Kedokteran Universitas IndonesiaVisabella R Triatmono, Study chair, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706585
- Sponsor's protocol ID
- MHS001
- Status last verified
- May 2021
- First submitted
- 8 Dec 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning on making the IPD available for other researchers due to the current format of our informed consent.
Publications
Marengo-Rowe AJ. The thalassemias and related disorders. Proc (Bayl Univ Med Cent). 2007 Jan;20(1):27-31. doi: 10.1080/08998280.2007.11928230.
PubMed 17256039Husna N, Sanka I, Arif AA, Putri C, Leonard E, Handayani NSN. Prevalence and distribution of thalassemia trait screening. J Med Sci. 2017 Jul;49(3):106-13.
Wahidiyat PA, Sari TT, Rahmartani LD, Setianingsih I, Iskandar SD, Pratanata AM, et al. An insight into Indonesian current thalassaemia care and challenges. ISBT Sci Ser. 2020;15(3):334-41.
Wahidiyat I, Wahidiyat PA. Genetic problems at present and their challenges in the future: thalassemia as a model. Paediatr Indones. 2006;46(5):189-94.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalassemia in Indonesia: Current Knowledge, Attitude, and Practice Among Young People
- ClinicalTrials.gov ID
- NCT04706585
- Acronym / sponsor ID
- MHS001
- Conditions
- Thalassemia
- Keywords
- Thalassemia, Indonesia, Youth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,010 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 13 Jan 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.
There is still an ongoing lack of awareness about thalassemia among Indonesians despite high disease prevalence, and this is associated with poor implementation of preventive and promotive measures. Thalassemia experts argue that education and raising awareness about thalassemia must be done from an early age in order to relieve the heavy disease burden of thalassemia, especially in Indonesia as it is geographically located in the thalassemia belt. In spite of this, there has been limited research on public perception towards thalassemia in Indonesia, particularly among young people.
In this study, the researcher will ask young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in an online survey. The survey consists of questions about the participants' demographic information as well as their knowledge, attitude, and practice (KAP) scores towards thalassemia. The study is expected to run from December 2020 to March 2021, with the online survey distributed in January 2021. Data collection will immediately follow, and it will be analyzed using univariate, bivariate, and multivariate analysis using the appropriate statistical tests. The findings gathered from this study will be vital in providing new insight into how the youth sees thalassemia in Indonesia. Such public health information will prove to be important in designing successful thalassemia intervention and education programs for Indonesian youth.
Detailed description
Research concept
In this study, the researcher will ask young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in an online survey. The survey consists of questions about the participants' demographic information as well as their knowledge, attitude, and practice (KAP) scores towards thalassemia. The study is expected to run from December 2020 to March 2021, with the online survey distributed in January 2021. Data collection will immediately follow, and it will be analysed using univariate, bivariate, and multivariate analysis using the appropriate statistical tests.
Study design
To evaluate the knowledge, attitude, and practice of Indonesian youth, the study design used will be observational, cross-sectional. An online questionnaire developed by the research team along with several experts is expected to be disseminated to the target population in January 2021. In light of the ongoing pandemic, this is expected to be a nationwide study where most of the work is done via online methods.
Place and period of study
This study will be conducted via online survey due to the ongoing pandemic situation. The study is expected to run from December 2020 to March 2021.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth | – | –Young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in our online survey. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- In this study, we will ask young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in our online survey.
Key inclusion criteria (4 listed)
- Survey participants are based in Indonesia
- Survey participants are between the age of 15-24 and currently attending high school or university level education
- Survey participants include both thalassemia-affected patients and non-patients
- Survey participants have understood and given their consent for the research
Key exclusion criteria (3 listed)
- Currently not studying/living in Indonesia
- Below the age of 15 or above 24
- No consent is given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Indonesian youth's level of knowledge on thalassemia
Time frame: Baseline, pre-intervention
To determine the relationships among Indonesian youth's demographic, education and socioeconomic level to their knowledge of thalassemia via a validated self-developed questionnaire. Knowledge will be assessed through question of common knowledges surrounding thalassemia, a final score (out of 100) will be used as representation of knowledge level (0-25: poor, 25-50 moderate, 51-75 good, and 76-100 very good) will be evaluated after participants answer all the questions.
Indonesian youth's attitude towards thalassemia
Time frame: Baseline, pre-intervention
To determine the relationships among Indonesian youth's demographic, education and socioeconomic level to their attitude towards thalassemia via a validated self-developed questionnaire. (using a Likert scale of 1 to 4 - with 1 being "strongly agree" and 4 "strongly disagree")
Indonesian youth's practice towards thalassemia
Time frame: Baseline, pre-intervention
To determine the relationships among Indonesian youth's demographic, education and socioeconomic level to their action and practice towards prevention of thalassemia via a validated self-developed questionnaire. (using a Likert scale of 1 to 4 - with 1 being "strongly agree" and 4 "strongly disagree")
1 secondary outcome
Willingness to undergo thalassemia screening
Time frame: Baseline, pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 17256039Marengo-Rowe AJ. The thalassemias and related disorders. Proc (Bayl Univ Med Cent). 2007 Jan;20(1):27-31. doi: 10.1080/08998280.2007.11928230.
- BackgroundHusna N, Sanka I, Arif AA, Putri C, Leonard E, Handayani NSN. Prevalence and distribution of thalassemia trait screening. J Med Sci. 2017 Jul;49(3):106-13.
- BackgroundWahidiyat PA, Sari TT, Rahmartani LD, Setianingsih I, Iskandar SD, Pratanata AM, et al. An insight into Indonesian current thalassaemia care and challenges. ISBT Sci Ser. 2020;15(3):334-41.
- BackgroundWahidiyat I, Wahidiyat PA. Genetic problems at present and their challenges in the future: thalassemia as a model. Paediatr Indones. 2006;46(5):189-94.
- Individual participant dataSharing planned: No. We are not planning on making the IPD available for other researchers due to the current format of our informed consent.
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
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.
Pustika A Wahidiyat, Professor. principal investigator
Fakultas Kedokteran Universitas Indonesia
Mikhael Yosia, Dr. principal investigator
Fakultas Kedokteran Universitas Indonesia
Edward C Yo study director
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 3 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 11 May 2021. 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 Indonesia. 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?
Contact Edward C Yo (+628973420875, edwardchristopheryo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indonesian youth's level of knowledge on thalassemia (time frame: Baseline, pre-intervention). The study lists 3 primary outcomes in all. 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 NCT04706585, which also lists 4 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 11 May 2021.