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Trial registered on ANZCTR


Registration number
ACTRN12618000956202
Ethics application status
Approved
Date submitted
30/05/2018
Date registered
6/06/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
VDOT2: The effect of medication event reminder monitoring upon adherence of patients taking treatment for tuberculosis in Vietnam
Scientific title
VDOT2: The effect of medication event reminder monitoring upon adherence of patients taking treatment for tuberculosis in Vietnam
Secondary ID [1] 293444 0
None
Universal Trial Number (UTN)
Trial acronym
VDOT2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-adherence to pulmonary tuberculosis treatment 305618 0
Condition category
Condition code
Respiratory 304842 304842 0 0
Other respiratory disorders / diseases
Public Health 304843 304843 0 0
Health promotion/education
Infection 307211 307211 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• Provided an adherence monitoring box to record daily adherence (MERM) and with alarm in designated time to alert patients to the time their dose is due. Wisepill, the monitoring box, makes use of mobile phone and Internet technologies to provide remote medication management. The Wisepill portable medication dispenser has a GSM communication chip at its heart. The dispenser sends an electronic medication event record to a central management system (Wisepill Web Server) whenever medication is taken. This truly portable device allows active patients to take their medicine with them wherever they go. It weights 125g with the size of 20 x 60 x 120mm and a rechargeable lithium battery which can run up to six months continuously.
• Routine monthly counseling on adherence provided by TB doctors and nurses at district tuberculosis unit where patient registered for TB treatment, tailored with individual adherence report of the preceding month. Approximately each counseling session lasts for 15 to 30 minutes, depends on the level of adherence to treatment of the previous months. They will discuss with the patient:
- factors contributing to non-adherence
- solutions to improve adherence
- adverse event management, if required
- a plan for meeting in the following month
• If the patient skips doses for two days or more, then they will receive intensive adherence support. This includes a phone call from health staff to discuss adherence. The topics are listed as above.

If the battery is low, according to the dashboard, they will be asked to come back for a battery change of the device.
Intervention code [1] 299686 0
Treatment: Devices
Intervention code [2] 299687 0
Behaviour
Comparator / control treatment
The control group consists of eligible patients who will be randomly allocated to control arm. They will be
- Provided an adherence monitoring box to record daily adherence but without alarm.
- Standard adherence advice at monthly visit from the national TB program without adherence report generated from the MERM.

, but without MERM alert. The proportion of individuals missing at least 3/15 doses (80%) per month on average will be the primary outcome measure. Monthly pill counts, by study staff or community health workers will be the secondary outcome measure, and will count the remaining number of doses that have not been consumed during the preceding month, and record on a treatment log.
Control group
Active

Outcomes
Primary outcome [1] 304046 0
The proportion of individuals missing less than 20% of doses per month on average.
Number of missing doses is measured by
- Electronic drug monitoring
- Monthly pill counts by health workers
Timepoint [1] 304046 0
Baseline, monthly after intervention commencement and until treatment is complete
Secondary outcome [1] 340786 0
The proportion of doses completed within full treatment course. This outcome will be assessed by pill count conducted by TB doctors or nurses during patient's monthly visit and recorded in the patient follow up card.
Timepoint [1] 340786 0
6 or 8 months after treatment initiation, depends on the treatment duration assigned by doctors.
Secondary outcome [2] 347743 0
Acceptability of digital adherence support, among outpatients with newly diagnosed smear positive pulmonary tuberculosis treated in Vietnam. This outcome will be measured based upon a questionnaire designed specifically for this study.
Timepoint [2] 347743 0
Treatment completion

Eligibility
Key inclusion criteria
• Patients with newly diagnosed microbiologically confirmed (smear positive and/or culture positive and/or Xpert MTB positive) pulmonary tuberculosis
• Taking only standard oral therapy for tuberculosis
• Taking treatment as an outpatient
• At least four months of treatment remaining
• Aged 15 years and above
Minimum age
15 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosed with multi-drug resistant TB prior to enrolment
• A history of prior treatment for tuberculosis, before the current episode.
• Severe mental illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9393 0
Viet Nam
State/province [1] 9393 0
Thanh Hoa

Funding & Sponsors
Funding source category [1] 298071 0
Charities/Societies/Foundations
Name [1] 298071 0
Australian Respiratory Council
Address [1] 298071 0
Level 6, 431 Glebe Point Road,
Glebe NSW 2037
Sydney
Australia
Country [1] 298071 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road
Glebe NSW 2037 Sydney, Australia
Country
Australia
Secondary sponsor category [1] 297148 0
None
Name [1] 297148 0
Address [1] 297148 0
Country [1] 297148 0
Other collaborator category [1] 279835 0
Hospital
Name [1] 279835 0
National Lung Hospital of Vietnam
Address [1] 279835 0
463 Hoang Hoa Tham street, Ba Dinh district, Ha Noi city
Country [1] 279835 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299091 0
Human Research Ethics Committee of the University of Sydney
Ethics committee address [1] 299091 0
Level 2, Margaret Telfer Building (K07)
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 299091 0
Australia
Date submitted for ethics approval [1] 299091 0
Approval date [1] 299091 0
06/04/2017
Ethics approval number [1] 299091 0
2017/226
Ethics committee name [2] 299092 0
Ethic Committee of Vietnam National Lung Hospital
Ethics committee address [2] 299092 0
463 Hoang Hoa Tham Street, Ba Dinh district, Ha Noi city
Ethics committee country [2] 299092 0
Viet Nam
Date submitted for ethics approval [2] 299092 0
01/06/2017
Approval date [2] 299092 0
14/09/2017
Ethics approval number [2] 299092 0
71/17/CT-HDKH-DD

Summary
Brief summary
Objective: To evaluate the feasibility and effectiveness of digital adherence support, among outpatients with newly diagnosed smear positive pulmonary tuberculosis treated in Vietnam.
Study design: A two-arm randomised controlled study that will compare digital adherence monitoring and automated reminders with scheduled history review, with a control group receiving standard self-administered therapy.
Sample size: 180 patients will be randomized into 2 arms of study
Study procedure: In summary, patients with confirmed pulmonary TB and meeting the above criteria will be invited to participate in the study. After giving consent form of agreement, the TB patient will be asked for complete a baseline questionnaire (Q1) and dispensed a digital adherence monitoring box to record daily adherence until the end of their completion therapy or until lost to follow up, transfer out or treatment failure is documented by the NTP staff, according to the NTP's definitions.
The participant will be randomised into one of two arms. In arm 1, the patient will receive a wisepill box to record adherence but NOT to provide alerts, they will be followed up by routine procedure regarding to the NTP's guideline. In arm 2, the patient will receive a wisepill box to record adherence with alarm, routine monthly counseling on adherence from health staff and tailored with individual adherence report, and phone call from health staff to remind patients to take pill if they skip 1 dose in the past one week.
Adherence will be evaluated based upon the report from electronic drug monitoring box, in addition of monthly remaining-pill count by the health staff.
At the end of each month follow up, the patient in two arms will be administered some follow-up questions in the Follow-up Card until their treatment outcome is recorded.
When the treatment is end, the patient will be invited to complete a questionnaire (Q2) asking them about the acceptability of the use of these devices, any problem encountered and overall satisfaction with the adherence monitoring method.
Outcomes:
The primary outcome will be the proportion of patients who miss less than 20% of doses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79258 0
A/Prof Gregory James Fox
Address 79258 0
THE UNIVERSITY OF SYDNEY
Rm 5216, Level 2 Medical Foundation Building K25
92-94 Parramatta Road | The University of Sydney | NSW | 2006
Country 79258 0
Australia
Phone 79258 0
+61 2 9114 0000
Fax 79258 0
+61 2 9114 0010
Email 79258 0
greg.fox@sydney.edu.au
Contact person for public queries
Name 79259 0
Dr Thu Anh Nguyen
Address 79259 0
Woolcock Institute of Medical Research - Vietnam
Apartment 203, Building 2G, Van Phuc Diplomatic Compound
298 Kim Ma street, Ba Dinh district, Ha Noi city,
Country 79259 0
Viet Nam
Phone 79259 0
+84939018686
Fax 79259 0
Email 79259 0
thuanh.nguyen@sydney.edu.au
Contact person for scientific queries
Name 79260 0
Dr Thu Anh Nguyen
Address 79260 0
Woolcock Institute of Medical Research - Vietnam
Apartment 203, Building 2G, Van Phuc Diplomatic Compound
298 Kim Ma street, Ba Dinh district, Ha Noi city,
Country 79260 0
Viet Nam
Phone 79260 0
+84939018686
Fax 79260 0
Email 79260 0
thuanh.nguyen@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
We have not included in our IRB approval on sharing IPD. If there is a need in the future, we will seek approval from our IRB in Sydney.
What supporting documents are/will be available?
No other documents available
Summary results
No Results