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Trial registered on ANZCTR


Registration number
ACTRN12619000329167
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
4/03/2019
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results information initially provided
4/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cost-effectiveness of health education intervention using WhatsApp among tuberculosis patients in improving treatment adherence and successful outcome
Scientific title
Cost-effectiveness of mHealth Intervention using WhatsApp in Promoting Medication Adherence and Treatment Success Among Pulmonary Tuberculosis Patients
Secondary ID [1] 297415 0
Nil
Universal Trial Number (UTN)
U1111-1228-6089
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
pulmonary tuberculosis 311584 0
Condition category
Condition code
Infection 310214 310214 0 0
Other infectious diseases
Respiratory 310265 310265 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant in the intervention group should received the health education module pertaining tuberculosis and its treatment which is developed during this study through WhatsApp. To avoid contamination of the intervention information, all the respondent was asked not to share any content of the WhatsApp they received with others.

Type of intervention: Health Education Intervention Module Using WhatsApp (mHealth)
Description as below:
Implementation method: Eligible respondents received health education module developed for this study through WhatsApp direct to their phone during intensive phase of DOT treatment (this is given once) and then 3 times reminder messages (total 3 messages over 4 months of maintenance phase of treatment). Example of messages are information pertaining Tuberculosis disease, how it spread, how to prevent it spread, the treatment option, what is the implication of not completing treatment and etc. The participant were required to read the messages and try to understand it. If they have any queries, they can ask through whatsApp messages. There are 3 sections in the health education module and each section is sent through whatsApp (total 30 messages and most messages were in picture format) given once in a day duration during 2 months of intensive phase of tuberculosis treatment.
Example of reminder messages: "have you finished reading the health information given through WhatsApp and please continue taking your medication until completed") until treatment completed as scheduled.

The adherence to medication were monitored through existing documentation for DOT in health clinic. Patients on DOT need to go to the nearest health facilities to take the daily medication. Health care providers will observe the patients swallowing the tuberculosis drugs in front of them and documented it into the TB record book using specific forms (TBIS 10-I) in the clinic and in patients’ home-based card as a proof that the patient had taken the medication. The routine is carried out daily, however, there are exception during weekends or public holiday whereby patients will be given supply of medications to be taken at home based on number of days required and directly observed therapy (DOT) need to be done by other family members or community members or self-reported. The other family members or community members need to document and signed on the patients home-based record book and need to be verified by health care provider upon next visit for DOT at the clinic.
Intervention code [1] 313662 0
Behaviour
Comparator / control treatment
For control group/Comparator: The eligible respondents received health education through current conventional method (face to face health education from healthcare provider with no structured module). This is usually done by healthcare provider and not monitored by the researcher how the health education was conducted. As mentioned, no structured health education module existed currently. The average health education received may vary from once to 6 times during follow-up in the clinic (over 6 months of treatment course). Note that the intervention group also will received similar conventional method of health education.

Apart of that, the control group need to have WhatsApp application in their phone too. however,they will only received reminder messages (3 times during their maintenance phase of treatment course over 4 months). Example of messages was "have you finished reading all the health education materials given by doctors if any?" they are not required to answer it as long as they already read the WhatsApp messages as indicated by "bluetick".
Control group
Active

Outcomes
Primary outcome [1] 319096 0
Tuberculosis medication adherence rate.

The rate is calculated based on the total days taken the medication by the respondent divided by the total planned dose (60 days for intensive dose and 120 days for maintenance dose). The rate is presented in percentage (0 to 100% of adherence) based on average medication taken during intensive phase and maintenance phase. This is calculated individually.

The information of days taken the medication is gathered from the record/documentation from healthcare provider in the clinic.


Timepoint [1] 319096 0
6-month post-enrollment where the treatment is expected to be completed by the respondent
Primary outcome [2] 319153 0
Knowledge, perception and self-care practice pertaining tuberculosis disease and its treatment.

This is done using self-administered questionaire developed during the study. The questionaire was pre-tested and validated among 50 respondents diagnosed with pulmonary tuberculosis attended Health Clinic in Seremban District. A Cronbach’s alpha coefficient above 0.70 is accepted as evidence of adequate internal consistency for the questionnaire. In this study, the reliability of the knowledge, motivation, and self-skills questionnaire was conducted using Cronbach alpha coefficient. The results of Cronbach’s alpha coefficient were 0.89, 0.73 and 0.7 respectively. Minor modification of the questionnaire was done including spelling error and arrangement of the questions.
Timepoint [2] 319153 0
Baseline (before intervention) and after 6-month post intervention
Secondary outcome [1] 366967 0
Treatment success.

The information for this was determined from the respondents record in Health Clinic and definition for treatment success is according to WHO (2014), the PTB treatment is a success if the outcome is either cured or treatment completed. A person with tuberculosis is categorized as cured if the disease is bacteriologically confirmed at the beginning of treatment who was sputum smear negative or culture-negative in the last month of treatment and on at least one previous occasion. A patient who completed treatment when there is no evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative, either because tests were not done or because results are unavailable.
Timepoint [1] 366967 0
6-month post-enrollment where the treatment is expected to be completed by the respondent
Secondary outcome [2] 367139 0
Cost-effectiveness ratio (CER)

CER is calculated according to government provider perspective. Each group (intervention and control group), the total cost was divided by the number of cases adhered and number of cases with treatment success to get cost per case adhered and costs per case with treatment success. The effectiveness of the intervention is ascertained if the cost per case adhered and costs per case with treatment success is lower in intervention group than control group.

The calculation for CER is,
CER = Cost per unit changes in intervention group/Cost per unit changes in control group (Changes refer to adherence or treatment success).
Timepoint [2] 367139 0
6-month post enrollment

Eligibility
Key inclusion criteria
The sampling population were the PTB cases in Negeri Sembilan who fulfils the eligibility criteria below.

Inclusion criteria:
i Newly diagnosed PTB (smear positive or negative) not more than 1 month on directly observed therapy (DOT).
ii Was prescribed by doctor on DOT treatment regimen for 6 months according to National Clinical Practice Guidelines for Tuberculosis year 2012.
iii Age 18 years and above.
iv Have access to WhatsApp via any gadjet/smartphone and has ability to use the application (personal or other family member’s gadjet/smartphone)

Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
i Mentally incapable (to provide consent)
ii Illiterate
iii Non-citizen
iv Vulnerable patients such as pregnant women, prisoners, cognitively impaired person, and terminally ill subjects based on current medical record documented in clinic.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.

The person incharge to send the WhatsApp is the Assistant Environmental Health Officer at District who is not directly involved with patient management and centre at District office. While, the Assistant Medical Officer in the clinic was not known which group patients were assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Upon receiving the notification of a PTB cases by the District Health Office, the Assistant Environmental Health Officer will investigate and verified the case and confirmed the diagnosis. The confirmed pulmonary tuberculosis cases were put in line-listing. The assignment of the group was based on sequential in block. There will be 6 blocked, block 1-ABAB, 2-BAAB, 3-BABA, 4-ABBA, 5-AABB, 6-BBAA which A refers to “intervention group” receiving health education intervention through WhatsApp and B refers to “control group”. Each block sequences were put in the envelope and the first block was randomly determined using table of random numbers. Block 6 was randomly selected as first block, therefore BBAA sequence used to assign the respondent into intervention or control group. The first and second patient in listing received intervention, while third and fourth patient in listing were assigned as control group. This was followed by the block 1, 2, 3, 4, 5 and until the sample size complete.

The Assistant Medical Officer in charge of tuberculosis program in health clinic were responsible of taking consent from the eligible respondents. The Assistant Medical Officer was not known which group patients were assigned. An officer will be in-charge at district level and she/he was the person who delivered the WhatsApp to the intervention group using a dedicated phone number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The sample size is calculated using the formula for two population proportion by Lemeshow, Klar & Lwanga (1990) at 95% confidence interval and statistical power of 80%.
Attrition rate also added ~20% from the sample size calculated and final sample size estimated was 55 for each group and total sample size 110.

Recruitment
Recruitment status
Completed
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] 21282 0
Malaysia
State/province [1] 21282 0
NEGERI SEMBILAN

Funding & Sponsors
Funding source category [1] 301982 0
Self funded/Unfunded
Name [1] 301982 0
Noor Haslinda Ismail
Address [1] 301982 0
Department of Community Health,
Faculty of Medicines and Clinical Sciences,
Universiti Putra Malaysia,
43400 Serdang, Selangor
Country [1] 301982 0
Malaysia
Primary sponsor type
University
Name
Department of Community Health
Address
Faculty of Medicines and Clinical Sciences
Universiti Putra Malaysia
43400 Serdang, Selangor
Country
Malaysia
Secondary sponsor category [1] 301761 0
None
Name [1] 301761 0
Address [1] 301761 0
Country [1] 301761 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302661 0
Medical Research and Ethics Committee, Ministry Of Health Malaysia
Ethics committee address [1] 302661 0
Health Management Institute,
Jalan Rumah Sakit Bangsar
59000 Kuala Lumpur
Ethics committee country [1] 302661 0
Malaysia
Date submitted for ethics approval [1] 302661 0
22/11/2016
Approval date [1] 302661 0
23/02/2017
Ethics approval number [1] 302661 0
NMRR-17-132-34290 (IIR)

Summary
Brief summary
This study aimed to determine the effectiveness and cost-effectiveness of mHealth intervention using WhatsApp in promoting medication adherence and treatment success among pulmonary tuberculosis (PTB) patients. The cost-effectiveness ratio will indicate which program is more value for money. The alternate hypothesis is health education intervention using WhatsApp is more effective and cost-effective than current face-to-face health education to promote medication adherence and treatment success.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90974 0
Dr Noor Haslinda Ismail
Address 90974 0
Department of Community Health,
Faculty of Medicines and Clinical Sciences,
Universiti Putra Malaysia,
43400 Serdang, Selangor
Country 90974 0
Malaysia
Phone 90974 0
+60122721484
Fax 90974 0
Email 90974 0
drhaslinda301@gmail.com
Contact person for public queries
Name 90975 0
Dr Noor Haslinda Ismail
Address 90975 0
Department of Community Health,
Faculty of Medicines and Clinical Sciences,
Universiti Putra Malaysia,
43400 Serdang, Selangor
Country 90975 0
Malaysia
Phone 90975 0
+60122721484
Fax 90975 0
Email 90975 0
drhaslinda301@gmail.com
Contact person for scientific queries
Name 90976 0
Dr Noor Haslinda Ismail
Address 90976 0
Department of Community Health,
Faculty of Medicines and Clinical Sciences,
Universiti Putra Malaysia,
43400 Serdang, Selangor
Country 90976 0
Malaysia
Phone 90976 0
+60122721484
Fax 90976 0
Email 90976 0
drhaslinda301@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
sociodemographic of the respondents and outcome of the study
When will data be available (start and end dates)?
immediately following publication and ending of 2 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1366 0
Ethical approval
Citation [1] 1366 0
Link [1] 1366 0
Email [1] 1366 0
Other [1] 1366 0
Type [2] 1367 0
Ethical approval
Citation [2] 1367 0
Link [2] 1367 0
Email [2] 1367 0
Other [2] 1367 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary