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Trial registered on ANZCTR


Registration number
ACTRN12619000554167
Ethics application status
Approved
Date submitted
1/04/2019
Date registered
9/04/2019
Date last updated
5/10/2021
Date data sharing statement initially provided
9/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An integrated public health strategy to manage chronic respiratory disease and reduce smoking in Vietnam: a pilot study
Scientific title
An integrated public health strategy to manage chronic respiratory disease and reduce smoking in Vietnam: a pilot study
Secondary ID [1] 297858 0
None
Universal Trial Number (UTN)
U1111-1230-9980
Trial acronym
The VCAPS3 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory health 312229 0
Nicotine addiction 312232 0
Condition category
Condition code
Respiratory 310774 310774 0 0
Asthma
Respiratory 310775 310775 0 0
Chronic obstructive pulmonary disease
Mental Health 310776 310776 0 0
Addiction
Public Health 310808 310808 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three interventions
1. Chronic respiratory disease intervention
A syndromic approach to diagnosis and treatment for patients with COPD/asthma. The treatment algorithm consists of three steps. Step 1 treatment uses as-needed budesonide/formoterol (160/4.5ug per dose) inhalation for relieving day-to-day respiratory symptoms. Step 2 includes twice daily and as-needed budesonide/formoterol (160/4.5ug per dose) inhalation. Patients who require step 3 treatment will be referred to a higher level health facility for respiratory specialist evaluation. Treatment will be stepped up when a patient is not under good symptom control or had an exacerbation, providing that the patient uses the inhaler treatment correctly.
After recruitment, all patients start with step 1 treatment. At 4 weeks, patients will return to the clinic for evaluation and decision on the treatment step. When returning for clinical assessment, patients are asked to bring back inhalers for evaluating treatment adherence and inhaler technique. The treating physician will also decide the time for the next clinical evaluation, when the decision on treatment step will take place again. All recruited patients will follow the treatment algorithm for one year.
The decision on staying in the same step, stepping up or down, is determined by treating physician based on the patient's symptom control, exacerbation, adherence to suggested treatment, and inhaler technique. For example, a patient under treatment step 1 had an exacerbation 2 weeks before this visit. The patient has a good inhaler technique and has been following the treatment step 1, evaluated by the treating physician. The physician should step up to treatment from step 1 to step 2.
2. Health facility smoking cessation intervention
Implementation of smoke-free hospital policy
Hospital leaders are responsible for formulating rules and implementing smoke-free hospital policy, with assistance from research staff. Smoke-free hospital policy includes the prohibition of smoking and selling tobacco products on the hospital premises. The regulations will be announced and all members in the hospital should follow, including patients and visitors.
Training for healthcare workers to provide brief advice on smoking cessation
A one-off 2-hour smoking cessation workshop will be held by research staff to train healthcare workers on brief intervention to patients. The workshop will include a lecture and practice of brief intervention using 5A's approach. Healthcare workers who are smokers are encouraged to quit.
After commencing the intervention, research staff will conduct regular visits to monitor the implementation. Issues identified will be raised and discussed with hospital leaders.
3. Patient smoking cessation intervention
Smoking cessation brief advice provided by healthcare workers at district facilities.
After the above-mentioned smoking cessation workshop, healthcare workers at the outpatient clinic, emergency department, and inpatient department will ask patients about smoking behaviour. For patients who are current smokers, healthcare workers will advise them to quit and invite them to join a follow-up smoking cessation programme.
Follow-up smoking cessation programme
Smokers who consent to join the programme will receive follow-up quitline counselling for 9 times (1 day, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, 6 months, 9 months, and 12 months after recruitment). Participants can also call the quitline if they need extra support. The follow-up programme also contains text messages to help participants quit smoking. The text message service is integrated with quitline counselling. The service lasts for 3 months, starting with one text per day and decreasing over time.
Intervention code [1] 314092 0
Treatment: Drugs
Intervention code [2] 314093 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319624 0
Proportion of patients with chronic respiratory disease who have at least one exacerbation during follow-up
The primary outcome will be assessed at 12 months. Research staff will collect the information about exacerbations from the patients via phone calls.
Timepoint [1] 319624 0
12 months after recruitment
Primary outcome [2] 319625 0
Proportion of verified smoking abstinence among smoking participants enrolled in the programme
The primary outcome will be assessed at 12 months. Quitline counsellors will collect the information about abstinence from the participants during their phone call. Participants with self-reported abstinence for at least 30 days will be verified with a cotinine test.
Timepoint [2] 319625 0
12 months after recruitment
Secondary outcome [1] 368916 0
The proportion of patients completing the cascade of care for chronic respiratory disease management
The cascade of care is a composite outcome that involves the following steps. The data will be collected at recruitment, follow-up visits, and phone call contacts made by research staff at 4 weeks, 3 months, 6 months, 9 months, and 12 months.
1. The proportion of patients attending a health facility presenting with chronic respiratory symptoms consistent with chronic respiratory disease.
Data will be collected by hospital staff on a form designed for collecting the information.
2. The proportion of patients with chronic respiratory symptoms who initiate diagnostic assessment
3. The proportion of patients who complete lung function assessment
Patients who undergo diagnostic assessment will have the data collected in a test report form, filled in by hospital staff.
4. The proportion of patients completing diagnostic assessment who are diagnosed with chronic respiratory disease.
5. The proportion of patients with chronic respiratory disease who commence treatment, according to the study algorithm.
The treating doctor will record the diagnosis and treatment on a case report form.
6. The proportion of patients who attend re-assessment 4 weeks after initiation of therapy
The treating doctor will record the result of the 4-week assessment a case report form.
7. The proportion of patients continuing recommended treatment 12 months after their initial presentation
Data will be collected by research staff via phone calls at 3 months, 6 months, 9 months, and 12 months.
Timepoint [1] 368916 0
4 weeks, 3 months, 6 months, 9 months, and 12 months

Eligibility
Key inclusion criteria
Chronic respiratory disease intervention
(a) Aged 12 years and over presenting to district health facilities, AND
(b) At least one of cough, dyspnea, wheeze, or chest tightness, AND
(c) A history of at least one prior episode of respiratory symptoms that has required attendance at a health care facility within the past two years, AND
(d) Demonstrated airflow limitation, defined as a pre-bronchodilator FEV1/FVC ratio less than 70% on spirometry or a peak flow meter reading less than 80% of predicted peak expiratory flow rate. OR
(e) Probable asthma: answering yes to at least three of the nine questions in the respiratory symptom questionnaire.

Smoking cessation intervention
(a) Aged 12 years and over presenting to district health facilities, AND
(b) Has smoked 100 cigarettes in his or her lifetime, AND
(c) Currently smokes cigarettes
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic respiratory disease intervention
(a) Patients who are allergic to budesonide or formoterol
(b) Pregnant women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/03/2019
Date of last participant enrolment
Anticipated
Actual
16/01/2020
Date of last data collection
Anticipated
Actual
16/01/2021
Sample size
Target
690
Accrual to date
Final
536
Recruitment outside Australia
Country [1] 21382 0
Viet Nam
State/province [1] 21382 0

Funding & Sponsors
Funding source category [1] 302383 0
Government body
Name [1] 302383 0
National Health and Medical Research Council
Country [1] 302383 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Rd, Glebe NSW 2037, Australia
Country
Australia
Secondary sponsor category [1] 302273 0
None
Name [1] 302273 0
Address [1] 302273 0
Country [1] 302273 0
Other collaborator category [1] 280627 0
Hospital
Name [1] 280627 0
Hanoi Lung Hospital
Address [1] 280627 0
44 Thanh Nhan, Hai Bb Trung, Hanoi
Country [1] 280627 0
Viet Nam
Other collaborator category [2] 280628 0
Hospital
Name [2] 280628 0
Bach Mai Hospital
Address [2] 280628 0
78 Ðuong Giai Phong, Phuong Ðinh, Ðong Ða, Hanoi
Country [2] 280628 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303056 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 303056 0
Ethics committee country [1] 303056 0
Australia
Date submitted for ethics approval [1] 303056 0
Approval date [1] 303056 0
19/12/2018
Ethics approval number [1] 303056 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92306 0
A/Prof Greg Fox
Address 92306 0
University of Sydney
Rm 5216, Level 2 Medical Foundation Building K25
92-94 Parramatta Road, The University of Sydney, NSW, 2006
Country 92306 0
Australia
Phone 92306 0
+61 2 9036 3121
Fax 92306 0
Email 92306 0
gregory.fox@sydney.edu.au
Contact person for public queries
Name 92307 0
Erick Wan-Chun Huang
Address 92307 0
Woolcock Institute of Medical Research
431 Glebe Point Rd, Glebe NSW 2037, Australia
Country 92307 0
Australia
Phone 92307 0
+61 450707959
Fax 92307 0
Email 92307 0
erick.huang@sydney.edu.au
Contact person for scientific queries
Name 92308 0
Erick Wan-Chun Huang
Address 92308 0
Woolcock Institute of Medical Research
431 Glebe Point Rd, Glebe NSW 2037, Australia
Country 92308 0
Australia
Phone 92308 0
+61 450707959
Fax 92308 0
Email 92308 0
erick.huang@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.