Internet plus health education on treatment adherence in patients with pulmonary tuberculosis
| ISRCTN | ISRCTN89499814 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89499814 |
- Submission date
- 08/08/2025
- Registration date
- 11/08/2025
- Last edited
- 11/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
There have been relatively few clinical studies evaluating the application of the Internet plus health education model among patients with Pulmonary tuberculosis. Against this backdrop, our study investigated the effect of Internet plus health education on treatment adherence in patients with PTB, aiming to provide evidence‐based guidance for nursing interventions in this population.
Who can participate?
Tuberculosis patients aged between 18 and 60 years
What does the study involve?
Health education for the control group was delivered by the primary nurse based on the standardized pulmonary tuberculosis education record.
Patients in the intervention group received a six‐month Internet plus health education program.
What are the possible benefits and risks of participating?
Improve treatment adherence, enhance disease knowledge, and increase patient satisfaction among individuals.
No risks.
Where is the study run from?
Beijing Chest Hospital, Capital Medical University (China)
When is the study starting and how long is it expected to run for?
September 2024 to June 2026
Who is funding the study?
Beijing Tongzhou District Science and Technology Plan Project (KJ2023CX053)
Beijing Research Ward Excellence Program (BRWEP2024W042160116)
Who is the main contact?
Chen Lv, lvchen_lc@126.com
Contact information
Dr Chen Lv
Public, Scientific, Principal Investigator
Public, Scientific, Principal Investigator
No. 9 Beiguan Street, Tongzhou District
Beijing
101149
China
| Phone | +86 15810190577 |
|---|---|
| lvchen_lc@126.com |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect of Internet plus health education on treatment adherence in patients with pulmonary tuberculosis |
| Study objectives | The Internet plus health education model, delivered via a WeChat Mini Program, may improve treatment adherence, enhance disease knowledge, and increase patient satisfaction among individuals with PTB |
| Ethics approval(s) |
Approved 21/07/2025, Ethics Committee of Beijing Chest Hospital, Capital Medical University (No. 9 Beiguan Street, Tongzhou District, Beijing, 101149, China; +86 10 89509134; zhangtongqun@sina.com), ref: LW-2025-022 |
| Health condition(s) or problem(s) studied | Treatment adherence in patients with pulmonary tuberculosis |
| Intervention | Participants were randomly assigned using a random number table to either the control group (n = 40) or the intervention group (n = 40). Control Group Health education for the control group was delivered by the primary nurse based on the standardized PTB education record form developed by the hospital’s Nursing Department. Education was provided during hospitalization and at discharge, covering the following aspects: 1. For newly admitted patients and their families, explanation of hospital visitation policies, daily routines, the importance of smoking cessation, and fall prevention measures 2. Principles and proper methods of disinfection, isolation, and mask usage 3. Basic knowledge of PTB 4. Instructions on correct sputum collection techniques and associated precautions 5. Information on venous thromboembolism, including prevention and risk factors 6. Purpose, significance, and precautions related to specialized diagnostic procedures (e.g., bronchoscopy, CT‐guided biopsy) and interventions (e.g., lumbar puncture, thoracentesis) 7. Guidelines for the use of anti‐tuberculosis medications and possible ADRs 8. The relationship between diet, rest, and disease recovery 9. For discharged patients and their families: home‐based disinfection and isolation protocols, medication adherence, recognition and management of potential ADRs, follow‐up schedules, and important considerations for home care. Intervention Group Patients in the intervention group received a six‐month Internet plus health education program, implemented as follows: 1. Establishment of Internet Plus Health Education Team: A multidisciplinary team was established, comprising one staff member from the Nursing Department, one head nurse from the tuberculosis ward, five primary nurses, and two network engineers. All team members possessed extensive experience in either PTB nursing management or information technology. The Nursing Department staff member was responsible for quality control; the head nurse oversaw the evaluation of health education outcomes; the primary nurses were tasked with delivering online health education, handling patient inquiries, and collecting and managing data; the network engineers were responsible for developing and maintaining the Internet plus health education platform. All team members underwent standardized training on platform usage and passed a competency assessment. Regular feedback meetings were held to address implementation challenges and drive continuous quality improvement. 2. Development of Internet Plus Health Education Content: Based on patient needs and grounded in the knowledge, attitude, practice (KAP) theoretical framework, the team consulted five experts from different domains to develop a structured and practical health education program. The program consisted of three major modules: A. PTB knowledge education, including guidance on basic disease information, diagnostic procedures, treatment options, medication use, and lifestyle recommendations B. Belief‐oriented education, including psychological support, family support, and social support C. Behavioral education, including instructions on disinfection and isolation, follow‐up routines, behavior tracking, and functional rehabilitation. The authority coefficient of the expert panel was 0.92, and the final educational framework was deemed standardized, practical, and feasible. 3. Development and Implementation of the Internet Plus Health Education Platform: The platform consisted of three functional interfaces: a system management terminal, a healthcare provider terminal, and a patient terminal. A. System Management Terminal: This interface supported the overall configuration and operation of the platform, including system setup, healthcare staff management, patient management, health education administration, patient inquiries and communication, and push notifications. It was responsible for platform maintenance and technical updates. B. Healthcare Provider Terminal: This interface included modules for patient record management, health consultations, information dissemination, and health follow‐up. Primary nurses used the platform as a new media tool to deliver patient‐centered care. In the patient record management module, nurses created and maintained individual health profiles. In the health consultation module, nurses responded to patient queries within 12 hours. The information dissemination module delivered electronic educational materials (including text and images) based on the structured Internet plus health education content, allowing patients to access information at any time. The health follow‐up module was used to send automated appointment reminders to patients’ mobile phones three days prior to scheduled follow‐up visits, as determined at the time of discharge. C. Patient Terminal: The patient interface included modules for health records, health education, health consultation, and peer communication. Patients could access educational materials pushed through the health education module; submit inquiries based on their individual need. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Adherence was measured via outpatient follow‐up cognitive assessment. Follow‐up behavior was categorized into three types: on‐time follow‐up, delayed follow‐up, and no follow‐up 2. Patient knowledge of pulmonary tuberculosis measured using a modified version of the Core Information and Key Knowledge Points for Pulmonary Tuberculosis Prevention and Control Assessment Questionnaire after six months of intervention 3. Patient Satisfaction measured using a satisfaction questionnaire after six months of intervention |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 20/09/2024 |
| Completion date | 27/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Aged between 18 and 60 years 2. Confirmed diagnosis of PTB according to standard diagnostic criteria 3. Absence of other serious physical or psychiatric comorbidities 4. Ability to communicate effectively with study personnel 5. Proficiency in using a smartphone 6. Residence within the Beijing metropolitan area 7. Provision of written informed consent |
| Key exclusion criteria | 1. Critically ill status due to PTB 2. History of severe psychiatric disorders or cognitive impairment 3. Refusal to participate in the study |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 30/11/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing Chest Hospital, Capital Medical University
No. 9 Beiguan Street, Tongzhou District
Beijing
101149
China
Beijing
101149
China
Sponsor information
Beijing Chest Hospital, Capital Medical University
Hospital/treatment centre
Hospital/treatment centre
No. 9 Beiguan Street, Tongzhou District
Beijing
101149
China
| Phone | +86 010 89509000 |
|---|---|
| webmaster@bjxkyy.cn | |
| Website | https://www.bjxkyy.cn/ |
Funders
Funder type
Government
Beijing Tongzhou District Science and Technology Plan Project (KJ2023CX053)
No information available
Beijing Research Ward Excellence Program (BRWEP2024W042160116)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current research are not expected to be available for privacy reasons. |
Editorial Notes
08/08/2025: Trial's existence confirmed by Ethics Committee of Beijing Chest Hospital, Capital Medical University.
