NCT07234929

Brief Summary

The study titled "Effectiveness of Chat-based Mobile Application for Consultation (Zalo) in Improving Compliance with Follow-up Tests after Abnormal Chest X-ray Findings Interpreted by Artificial Intelligence" aims to evaluate whether digital communication can enhance patient adherence to follow-up evaluations after lung disease screening in Vietnam. Lung cancer and tuberculosis (TB) remain leading causes of morbidity and mortality in Vietnam. Despite advances in screening technologies, including low-dose CT and AI-assisted chest X-rays, many patients fail to follow up after receiving abnormal results, resulting in delayed diagnosis and treatment. Communication barriers, low health literacy, and limited consultation time are key factors behind this gap. Digital health tools such as chat-based mobile applications offer potential to strengthen post-screening engagement and improve health outcomes. This randomized controlled trial will be conducted at Nhan Dan Gia Dinh Hospital in Ho Chi Minh City between October 2025 and October 2026. Participants aged 40-62 years, who undergo routine chest X-ray screening interpreted by AI software (qXR by QURE.AI), will be randomly assigned to either the intervention or control group. All participants must have an active Zalo account. In the intervention group, participants will receive their AI-interpreted results and educational guidelines for lung cancer or TB through the research team's Zalo account. The guideline covers disease overview, diagnostic methods, follow-up recommendations, and lifestyle guidance. Participants may ask questions directly to doctors specializing in nutrition, respiratory medicine, and pulmonary pathology, with guaranteed responses within 4 hours during working hours and 10 hours after hours. Messages are also sent via email as backup. The hospital's IT department oversees the Zalo platform to ensure data security. In the control group, participants will receive only the doctor's conclusion and brief advice via Zalo and email. They will be invited to connect with the hospital's official Zalo account for general inquiries but will not receive further digital consultation. Follow-up calls will assess compliance. For positive or suspected cases, research staff will call one month after result notification to confirm whether participants completed follow-up tests. For negative cases, calls will occur at six months to check for new symptoms or additional imaging. Structured questionnaires will document reasons for compliance or noncompliance. The study does not provide additional diagnostic services; all follow-up costs are covered by participants or their health insurance. The primary outcome is the rate of compliance with recommended follow-up tests. The secondary outcome measures participants' responsiveness to follow-up phone calls. Statistical analyses will compare compliance rates between groups using chi-square or Fisher's exact tests and risk ratios with 95% confidence intervals. Sample size calculations estimate that 2,692 participants are required to detect a 10% improvement in follow-up compliance (from 85% to 95%) with 80% power and 5% significance. Randomization will use REDCap software with block sizes of 2-8. Interviewers conducting follow-up calls will be blinded to group allocation. Ethical approval will be obtained from the Nhan Dan Gia Dinh Hospital Ethics Committee, and the study will be registered at ClinicalTrials.gov. Data confidentiality will be strictly maintained, with all digital records password-protected and accessible only to authorized research members. This project is the first randomized controlled trial in Vietnam to evaluate the effectiveness of chat-based mobile consultation in improving post-screening compliance for lung diseases. It leverages Vietnam's high mobile phone penetration and the popularity of Zalo to create a scalable model for patient engagement. Expected benefits include improved communication, increased awareness of lung cancer and TB, reduced loss to follow-up, and faster diagnostic confirmation. The findings will provide scientific evidence for integrating digital communication into screening programs and contribute to national efforts to improve early detection and management of lung diseases.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,692

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
20mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • compliance rate of the follow-up test(s)

    The main outcome of this study is the compliance rate of the follow-up test(s). This mean participants doing follow-up tests over the period of one month for positive cases and 6 months for negative cases. For outcome ascertainment, it is considered importantly to verify the clinical status using hospital medical records for patients who continued lung disease follow tests. Reliance on telephone interviews alone may lead to misclassification. Therefore, we will try to make confirmation through review of existing medical records should be conducted, particularly for those who did in our healthcare facility. For those did in another healthcare facilities, we will try to encourage them to provide the health record if possible.

    one month for positive cases, 6 months for negative cases

Secondary Outcomes (1)

  • compliance rate of responding to phone call

    one month for positive cases, 6 months for negatives cases

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive lung disease screening (chest x-ray interpreted by AI) announcements and educational guidelines via the study's Zalo app account (and by email as backup). Guidelines include information on disease overview, diagnosis, follow-up, and healthy behavior for TB or lung cancer will also be provided to participants. Furthermore, doctors in nutrition, respiratory, and pulmonary fields answer participants' related respiratory illness questions within 4 hours in working time and 10 hours after, supervised by coordinators and the PI. The Zalo platform is research-managed but monitored by hospital IT. We will follow-up one month for positive result cases and 6 months for negative result cases. A structured questionnaire will be interviewed by phone call for reasons for doing follow-up tests or not. Diagnostic tests and costs are participants' responsibility per health insurance or self-payment.

Other: chat-based mobile application (Zalo)

Control group

NO INTERVENTION

Participants receive lung disease screening (chest x-ray interpreted by AI) announcements and doctor's advice via the study's Zalo app account (and by email as backup). If they have any question related to their health issues, they will be invited to connect to Nhan dan Gia Dinh hospital's official Zalo account (separately from research team's Zalo account). We will also follow-up one month for positive result cases and 6 months for negative result cases. A structured questionnaire will be interviewed by phone call for reasons for doing follow-up tests or not. Diagnostic tests and costs are participants' responsibility per health insurance or self-payment. in summary, the control group won't recieve guildelines about the illness which provided by research team and chat-based support for respiratory illness compare to intervention group

Interventions

this intervention are chat-based activities (including providing illness guidelines and chat-based environment) to encourage participants to compliance doctor's recommendation to do early further tests if they have positive lung disease screening result or they develop lung disease symptoms which suspected to lung cancer or TB

Intervention group

Eligibility Criteria

Age40 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals aged 40 to 62 years old and are still working
  • In risk population, which means they exposure at least 2 risk factors of lung cancer, following:
  • smoking
  • expose second-hand smoke
  • expose air pollution, bio-mass fuels
  • expose arsenic
  • expose radon
  • expose asbestos
  • having chronic pulmonary illness
  • having HIV
  • have family member's history of lung cancer (relatives within 3 generations)
  • Have mobile phone registered Zalo account

You may not qualify if:

  • Individual smoked or had history of smoking more than 30 packs per year because they will be advised to do low dose CT scan. That is based on the guideline from Vietnam Misnitry of Health101
  • Pregnant woman. It is for safety reason because we will recommend the (+) cases or (-) cases with symptoms do LDCT or CT scan for lung cancer, that can affect the pregnancy. Therefore, if they are pregnant, we will invite them to meet obstetricians.
  • History of lung cancer or TB
  • Who have problem in mental health is diagnosed by doctor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nhan Dan Gia Dinh Hospital

Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Lung NeoplasmsTuberculosisPatient Compliance

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kiet Anh Vu, MPH

    Nhan dan Gia Dinh Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

November 15, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations