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Trial registered on ANZCTR


Registration number
ACTRN12619001720101
Ethics application status
Approved
Date submitted
20/09/2019
Date registered
5/12/2019
Date last updated
5/12/2019
Date data sharing statement initially provided
5/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cost-effectiveness of Family Support Health Education Intervention to Improve Health-related Quality of Life Among Pulmonary Tuberculosis Patients in Melaka
Scientific title
Cost-effectiveness of Family Support Health Education Intervention to Improve Health-related Quality of Life Among Pulmonary Tuberculosis Patients in Melaka
Secondary ID [1] 299358 0
None
Universal Trial Number (UTN)
U1111-1240-6873
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 314515 0
Condition category
Condition code
Infection 312862 312862 0 0
Other infectious diseases
Respiratory 313449 313449 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Family Support Health Education Intervention Based on Health Belief Model

The health education (one hour session) will be given face-to-face to patient and family members, once, during the home visit after diagnosis, by a medical officer

The patient and their family members are expected to learn about; the important topics such as the modes of Pulmonary Tuberculosis (PTB) transmission, the prevention of PTB, common signs of PTB, the importance of completing treatment and the consequences if not completed, possible complications, the importance of frequent checkups for other family members, the infection control, and latent TB infection. (All will be explained based on the Health Belief Model principles; Perceived Susceptibility, Perceived Severity, Perceived Benefits, Perceived Barriers, Cues to Action, Self-Efficacy)

2) Weekly phone message (given weekly for the 6 months treatment period) will be given to remind patient on the treatment compliance

The important message is to remind and encourage family members to keep motivating PTB patient to adhere to the medication (Cues to Action). Patients must take their anti-TB medication in a timely and consistent manner to prevent the spread and complications (development of drug resistant TB, more severe cases of the disease and death) of the disease and for treatment (Perceived Severity).
Intervention code [1] 315626 0
Behaviour
Comparator / control treatment
Conventional health education to the patient (not involve family members) during diagnosis at health facility by medical assistant

The health education is a simple and brief education about the basic information on TB, provided by a medical assistant, not by a medical officer

Not based on any theory of behaviour

No follow-up after the session

No phone message reminder
Control group
Active

Outcomes
Primary outcome [1] 321466 0
Health-related Quality of Life (HRQoL) by using SF-36 questionnaire
Timepoint [1] 321466 0
At diagnosis
At 2 months post diagnosis
At 6 months post diagnosis (complete treatment)
Secondary outcome [1] 375058 0
Treatment outcome will be assessed after 6 months of medication regime and they are either; cured, successful, defaulted and death, and these will be assessed clinically based on the symptoms, patient's general condition and lab markers i.e. the sputum investigations and chest x-rays
Timepoint [1] 375058 0
At 6 months post diagnosis (complete treatment)

Eligibility
Key inclusion criteria
i. All Malaysian patients
ii. Aged = 18 years old and above including 18 years old (adult PTB cases)
iii.Confirmed as new PTB case
iv.Started on TB treatment
v.Literate patients
vi. Patients who staying with family members (spouse, children, siblings, parents)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Non-Malaysians patients
ii.Those too ill to participate
iii.Re-treatment PTB patients
iv. PTB patients started on treatment from private facilities
v. PTB with other co-morbidities such as diabetes, HIV, heart disease, etc.
vi. PTB patients who is a family member to another PTB patients whose already recruited into this study

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 was determined by the holder of the sequence who is situated off site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The two means for hypothesis testing formula (Lemeshow, Hosmer Jr, Klar, & Lwanga, 1990) is used for estimating the sample size for this study.

n = [2 s2 (Za/2+Zß) 2] / d2

Where,
Za/2 = the critical value of the Normal distribution at a/2 (e.g. for a confidence level of 95%, a is 0.05 and the critical value is 1.96),
Zß = the critical value of the Normal distribution at ß (e.g. for a power of 80%, ß is 0.2 and the critical value is 0.84),
s2 = the population variance, and
d = the difference of two means (mean 1 – mean 2)

Using a study by Ting-Li et al. (2017), entitled “Evaluation of health-related quality of life in patients with tuberculosis who completed treatment in Kiribati” with information of s2 = 8.62, d2 = 1.88;

n = [(1.96 + 0.842)2 x 2 x 8.62] / 1.88

= 72 patients per group x 2 groups (intervention vs control)
= 144 patients, taking a 20% drop out rate;
= 172 patients

The software SPSS version 24 will be used for data analysis. The scoring data for SF-36 questionnaire will be obtained from Quality Metric Health Outcomes Scoring Software before further analyze using SPSS. The descriptive analysis will be performed using frequencies, mean and standard deviation if the data is normally distributed, median and interquartile range (IQR) if the data is not normally distributed, for socio-demographic, patient factors and SF-36 quality of life domains.

Normality test will be done for continuous variable such as age and SF-36 quality of life domains graphically and statistically. Normal distribution of data will be confirmed statistically by using the analysis of normality, the Shapiro-Wilk test, or the Kolmogorov-Smirnov test. Analysis of Covariance (ANCOVA) will be used to evaluate the effectiveness of the intervention, adjusted for baseline covariates on both continuous and categorical variables. The 95% confidence interval (95% CI) will be set for means estimation, with p-value at 0.05 for the level of significance to reject null hypothesis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/12/2019
Actual
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment outside Australia
Country [1] 21877 0
Malaysia
State/province [1] 21877 0
Melaka

Funding & Sponsors
Funding source category [1] 303872 0
Self funded/Unfunded
Name [1] 303872 0
non applicable
Country [1] 303872 0
Primary sponsor type
Government body
Name
Malaysia Ministry of Health
Address
Blok E1, E3, E6, E7, & E10,
Kompleks E,
Pusat Pentadbiran Kerajaan Persekutuan,
62590 Putrajaya, Wilayah Persekutuan,
Malaysia.
Country
Malaysia
Secondary sponsor category [1] 304015 0
None
Name [1] 304015 0
non applicable
Address [1] 304015 0
non applicable
Country [1] 304015 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304379 0
Medical Research and Ethics Committee Ministry of Health Malaysia
Ethics committee address [1] 304379 0
Ethics committee country [1] 304379 0
Malaysia
Date submitted for ethics approval [1] 304379 0
01/07/2019
Approval date [1] 304379 0
16/08/2019
Ethics approval number [1] 304379 0
NMRR-19-1345-47678

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

Contacts
Principal investigator
Name 96754 0
Dr Mohamad Syafiq Mohamad Saidi
Address 96754 0
Universiti Putra Malaysia (UPM),
Serdang, 43400 Seri Kembangan,
Selangor, Malaysia.
Country 96754 0
Malaysia
Phone 96754 0
+60193499996
Fax 96754 0
Email 96754 0
syafiqsidqisaidi1985@gmail.com
Contact person for public queries
Name 96755 0
Mohamad Syafiq Mohamad Saidi
Address 96755 0
Universiti Putra Malaysia (UPM),
Serdang, 43400 Seri Kembangan,
Selangor, Malaysia.
Country 96755 0
Malaysia
Phone 96755 0
+60193499996
Fax 96755 0
Email 96755 0
syafiqsidqisaidi1985@gmail.com
Contact person for scientific queries
Name 96756 0
Muhamad Hanafiah Juni
Address 96756 0
Universiti Putra Malaysia (UPM),
Serdang, 43400 Seri Kembangan,
Selangor, Malaysia.
Country 96756 0
Malaysia
Phone 96756 0
+60136215276
Fax 96756 0
Email 96756 0
hanafiah_juni@upm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Published results only
When will data be available (start and end dates)?
Immediately after publication, and no end date.
Available to whom?
Anyone interested with the research
Available for what types of analyses?
Related with the research
How or where can data be obtained?
Access subject to approvals by Principal Investigator

Dr. Mohamad Syafiq Sidqi Mohamad Saidi
Universiti Putra Malaysia,
Serdang, 43400 Seri Kembangan,
Selangor, Malaysia.

syafiqsidqisaidi1985@gmail.com


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.