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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

14/07/2020

Date data sharing statement initially provided

4/06/2019

Date results provided

14/07/2020

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]

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

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Public Health

Health promotion/education

Infection

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]

Treatment: Devices

Intervention code [2]

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]

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]

Baseline, monthly after intervention commencement and until treatment is complete

Secondary outcome [1]

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]

6 or 8 months after treatment initiation, depends on the treatment duration assigned by doctors.

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

Actual

5/10/2017

Date of last participant enrolment

Anticipated

31/08/2019

Actual

9/07/2019

Date of last data collection

Anticipated

28/04/2020

Actual

31/03/2020

Sample size

Target

250

Accrual to date

Final

250

Recruitment outside Australia

Country [1]

Viet Nam

State/province [1]

Thanh Hoa

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Respiratory Council

Address [1]

Level 6, 431 Glebe Point Road,
Glebe NSW 2037
Sydney
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

National Lung Hospital of Vietnam

Address [1]

463 Hoang Hoa Tham street, Ba Dinh district, Ha Noi city

Country [1]

Viet Nam

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee of the University of Sydney

Ethics committee address [1]

Level 2, Margaret Telfer Building (K07)
The University of Sydney
NSW 2006 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/04/2017

Ethics approval number [1]

2017/226

Ethics committee name [2]

Ethic Committee of Vietnam National Lung Hospital

Ethics committee address [2]

463 Hoang Hoa Tham Street, Ba Dinh district, Ha Noi city

Ethics committee country [2]

Viet Nam

Date submitted for ethics approval [2]

01/06/2017

Approval date [2]

14/09/2017

Ethics approval number [2]

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

A/Prof Gregory James Fox

Address

THE UNIVERSITY OF SYDNEY
Rm 5216, Level 2 Medical Foundation Building K25
92-94 Parramatta Road | The University of Sydney | NSW | 2006

Country

Australia

Phone

+61 2 9114 0000

Fax

+61 2 9114 0010

[email protected]

Contact person for public queries

Name

Thu Anh Nguyen

Address

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

Viet Nam

Phone

+84939018686

Fax

[email protected]

Contact person for scientific queries

Name

Thu Anh Nguyen

Address

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

Viet Nam

Phone

+84939018686

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effect of medication event reminder monitoring on treatment adherence of TB patients.	2023	https://dx.doi.org/10.5588/ijtld.22.0500

N.B. These documents automatically identified may not have been verified by the study sponsor.

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