Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06441981
Other study ID # WGS Project
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date December 30, 2024

Study information

Verified date May 2024
Source Indonesia University
Contact Rina Agustina
Phone +622129189160
Email r.agustina@ui.ac.id
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Gap in understanding undermines government and public support for SC2-WGS, and other wide-scale genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) as a routine part of the pandemic response, especially in low- and middle-income countries. However, such gaps can be closed with systematic efforts to define and measure specific misperceptions, and subsequently design and use targeted messages and promotional materials. We propose here in the following specific aims to first determine the entire set of beliefs and emotions regarding SC2-WGS and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing), then identify and measure limiting belief constructs, and then create social media and communication media to address and overcome limiting beliefs strategically. The goal is to increase public and policymaker support for SC2-WGS and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) resources and actions for pandemic control.


Description:

Implementing WGS, it is advisable to involve a variety of relevant actors and to consider the opinions of various stakeholders, including those who are not professionals in the field. This might resolve the implementation problem that could occur if psychological and social dimensions or, in other words, not strictly scientific criteria are not adequately integrated in decision making concerning complex issues such as innovations in genetics. In most cases, the reaction towards genetic information corresponds with a specific personal view of how to handle medical information and thus amplifies already existing mental phenomena (fear, stress, worries, etc.), tendencies of self-improvement and self-care and curiosity and playfulness.38 In the Study from Lewis et al, investigated in this relation the specific personality traits of participants of the first implementations of WGS, who were characterized as optimistic and resilient. This is a phenomenon often found in the group of early adopters of new technologies in general as described in the dimension knowing as empowerment to act, for some people, the willingness to know is caused by an attitude of openness towards the unknown and the desire to open new scenarios that could activate new opportunities for research as well as for themselves. This perspective highly reflects the currently dominant societal goal of health prevention and the main health policy discourse and practice of precaution. People have different perceptions of WGS and its imaginable integration into our health care system or our daily lives, and various approaches to decision-making regarding the potential use of WGS could be observed. There are suboptimal national resources, inadequate specimen sampling strategies, to optimize epidemiological and clinical inference. There is a gap in the meta-data to interpret SC2-WGS information and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) in a complete and rapid manner. This understanding gap can undermine broad-scale government and public support as a routine part of the pandemic response, especially in low- and middle-income countries. Therefore an intervention is needed in the form of genomic sequencing education. Before the intervention stage, there will be taking survey data which will be collected using the themes from the FGD results and will focus on assessing public perceptions regarding SC2-WGS and other genomic sequencing. These themes will be formulated into short statements and answered by respondents using a Likert scale. The survey will involve 100-200 respondents via WhatsApp chat bot. Subjects will be asked to express their reactions to short statements on a 4-point Likert scale. The subject will also be asked to express his emotional reaction to the statement with a series of binary questions related to positive or negative feelings. The survey results will be analyzed quantitatively to see the total score and distribution of each statement. The next stage in this research is to develop social media and communication media. At this stage we will formulate public messages and strategies to improve perceptions based on the survey results. The public message formulated will be useful for educating the public using various social media platforms. The intervention stage will be carried out by distributing information regarding genome sequencing via bots. After the intervention is carried out, changes in perception will be assessed before and after the intervention through pre-test and post-test questionnaires


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 30, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria: - Living or working in Jakarta - Young adult - Adult - Elderly - Health workers - Public Policy Exclusion Criteria: - Living or working outside Jakarta

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Education
Educational material brochures will be given to 800 respondents. Educational material is provided via WhatsApp chatbot. After being educated, respondents were given a test to determine the increase in understanding of the material.

Locations

Country Name City State
Indonesia Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia Jakarta Pusat DKI Jakarta

Sponsors (2)

Lead Sponsor Collaborator
Indonesia University Oxford University Clinical Research Unit

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

Lewis KL, Han PK, Hooker GW, Klein WM, Biesecker LG, Biesecker BB. Characterizing Participants in the ClinSeq Genome Sequencing Cohort as Early Adopters of a New Health Technology. PLoS One. 2015 Jul 17;10(7):e0132690. doi: 10.1371/journal.pone.0132690. eCollection 2015. — View Citation

Schumann S, Gschmeidler B, Pellegrini G. Knowing, relationships and trust-citizens' perceptions of whole genome sequencing for the Genetics Clinic of the Future. J Community Genet. 2021 Jan;12(1):67-80. doi: 10.1007/s12687-020-00486-0. Epub 2020 Sep 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Knowledge Assessment of respondents' knowledge regarding the educational material provided, calculated based on the number of questions answered correctly. 2 months
See also
  Status Clinical Trial Phase
Completed NCT04531761 - Evaluating the Efficacy of the Parent Support Program N/A
Not yet recruiting NCT05623202 - Pilot Study of Capacity-oriented Intervention to Promote Food Security and Diet Quality Among Hispanics/Latinos N/A
Not yet recruiting NCT03740269 - Oral Health Educational Program for Knowledge,Attitude,Practice of Oral Health Among Agroup of Egyptian School Girls
Recruiting NCT05626231 - Development of a Training Intervention to Improve Mental Health Treatment for Gender Minority Youth N/A
Completed NCT05297721 - Nurses' Level of Knowledge on Skin Tears: A Cross-Sectional Study
Completed NCT04096196 - A Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours N/A
Recruiting NCT05454618 - The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Not yet recruiting NCT05036057 - Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)
Recruiting NCT06100198 - The Effect of Nutrition and Exercise Program on the Health of Community-dwelling Older Adults N/A
Completed NCT03287622 - Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents N/A
Withdrawn NCT05073562 - Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia N/A
Completed NCT03673267 - Nutricity: A Pilot Study to Improve Parental Nutrition Literacy N/A
Completed NCT05244161 - A Quasi-experimental Evaluation of the Malezi Program in Tanzania N/A
Recruiting NCT04888416 - Implementing Outcome Measures in Stroke Rehabilitation N/A
Completed NCT03710837 - The Effect of Pain Education on Multidisciplinary Healthcare Students' Understanding of Chronic Pain N/A
Completed NCT04128241 - Knowledge, Attitudes and Practices on Fad Diets of a Panel of Spanish Consumers: Protocol of a Cross-sectional Study
Completed NCT04656522 - Comic Intervention for Sexual Violence Prevention and Post-rape Care N/A
Completed NCT04184219 - Determinants of Knowledge About and Use of Dietary Supplements
Recruiting NCT04182282 - Online Training & Certification for Competency in Dementia Friendly Hospital Care N/A
Completed NCT03774602 - Evaluation of the Maternal and Child Survival Program (MCSP) in Mozambique Using Mixed Methods N/A