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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
Date results information initially provided
5/10/2021
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
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Scientific title
An integrated public health strategy to manage chronic respiratory disease and reduce smoking in Vietnam: a pilot study
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Secondary ID [1]
297858
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None
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Universal Trial Number (UTN)
U1111-1230-9980
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Trial acronym
The VCAPS3 Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory health
312229
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Nicotine addiction
312232
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Condition category
Condition code
Respiratory
310774
310774
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0
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Asthma
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Respiratory
310775
310775
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0
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Chronic obstructive pulmonary disease
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Mental Health
310776
310776
0
0
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Addiction
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Public Health
310808
310808
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0
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Other public health
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314092
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Treatment: Drugs
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Intervention code [2]
314093
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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12 months after recruitment
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Primary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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12 months after recruitment
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Secondary outcome [1]
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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.
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Assessment method [1]
368916
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Timepoint [1]
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4 weeks, 3 months, 6 months, 9 months, and 12 months
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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
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Chronic respiratory disease intervention
(a) Patients who are allergic to budesonide or formoterol
(b) Pregnant women
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
27/03/2019
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Date of last participant enrolment
Anticipated
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Actual
16/01/2020
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Date of last data collection
Anticipated
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Actual
16/01/2021
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Sample size
Target
690
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Accrual to date
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Final
536
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Recruitment outside Australia
Country [1]
21382
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Viet Nam
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State/province [1]
21382
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421 Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Woolcock Institute of Medical Research
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Address
431 Glebe Point Rd, Glebe NSW 2037, Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
302273
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Country [1]
302273
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Other collaborator category [1]
280627
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Hospital
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Name [1]
280627
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Hanoi Lung Hospital
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Address [1]
280627
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44 Thanh Nhan, Hai Bb Trung, Hanoi
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Country [1]
280627
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Viet Nam
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Other collaborator category [2]
280628
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Hospital
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Name [2]
280628
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Bach Mai Hospital
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Address [2]
280628
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78 Ðuong Giai Phong, Phuong Ðinh, Ðong Ða, Hanoi
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Country [2]
280628
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Viet Nam
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee, University of Sydney
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Ethics committee address [1]
303056
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Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
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Ethics committee country [1]
303056
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Australia
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Date submitted for ethics approval [1]
303056
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Approval date [1]
303056
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19/12/2018
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Ethics approval number [1]
303056
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Summary
Brief summary
This is a pilot study aims to assess the feasibility of an integrated public sector intervention that is hypothesised to (a) reduce the number of exacerbations among individuals with chronic respiratory disease presenting to healthcare facilities and (b) reduce the proportion of current smokers among patients presenting to healthcare facilities and healthcare workers in the facilities.
Three interventions will be implemented, including (a) chronic respiratory disease intervention, (b) patient smoking cessation intervention, and (c) health facility smoking cessation intervention. This study will be conducted in three government district health facilities in rural districts of Hanoi Capital, Vietnam. Participants will be followed for 12 months.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Greg Fox
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Address
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University of Sydney
Rm 5216, Level 2 Medical Foundation Building K25
92-94 Parramatta Road, The University of Sydney, NSW, 2006
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Country
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Australia
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Phone
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+61 2 9036 3121
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Fax
92306
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Erick Wan-Chun Huang
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Address
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Woolcock Institute of Medical Research
431 Glebe Point Rd, Glebe NSW 2037, Australia
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Country
92307
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Australia
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Phone
92307
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+61 450707959
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Fax
92307
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Email
92307
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[email protected]
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Contact person for scientific queries
Name
92308
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Dr Erick Wan-Chun Huang
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Address
92308
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Woolcock Institute of Medical Research
431 Glebe Point Rd, Glebe NSW 2037, Australia
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Country
92308
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Australia
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Phone
92308
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+61 450707959
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Fax
92308
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Email
92308
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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