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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
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Scientific title
Cost-effectiveness of Family Support Health Education Intervention to Improve Health-related Quality of Life Among Pulmonary Tuberculosis Patients in Melaka
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Secondary ID [1]
299358
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None
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Universal Trial Number (UTN)
U1111-1240-6873
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tuberculosis
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Condition category
Condition code
Infection
312862
312862
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0
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Other infectious diseases
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Respiratory
313449
313449
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
315626
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Behaviour
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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Health-related Quality of Life (HRQoL) by using SF-36 questionnaire
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Assessment method [1]
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Timepoint [1]
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At diagnosis
At 2 months post diagnosis
At 6 months post diagnosis (complete treatment)
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Secondary outcome [1]
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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
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Assessment method [1]
375058
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Timepoint [1]
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At 6 months post diagnosis (complete treatment)
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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)
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Minimum age
18
Years
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Maximum age
65
Years
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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
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
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
16/12/2019
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Actual
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Date of last participant enrolment
Anticipated
31/03/2020
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Actual
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Date of last data collection
Anticipated
30/09/2020
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Actual
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Sample size
Target
172
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21877
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Malaysia
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State/province [1]
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Melaka
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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non applicable
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Address [1]
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non applicable
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Country [1]
303872
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Primary sponsor type
Government body
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Name
Malaysia Ministry of Health
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Address
Blok E1, E3, E6, E7, & E10,
Kompleks E,
Pusat Pentadbiran Kerajaan Persekutuan,
62590 Putrajaya, Wilayah Persekutuan,
Malaysia.
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Country
Malaysia
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Secondary sponsor category [1]
304015
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None
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Name [1]
304015
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non applicable
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Address [1]
304015
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non applicable
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Country [1]
304015
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304379
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Medical Research and Ethics Committee Ministry of Health Malaysia
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Ethics committee address [1]
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Kompleks Institut Kesihatan Negara, No. 1 Jalan Setia Murni U13/52, Seksyen
U13 Bandar Setia Alam, 40170 Malaysia.
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Ethics committee country [1]
304379
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Malaysia
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Date submitted for ethics approval [1]
304379
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01/07/2019
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Approval date [1]
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16/08/2019
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Ethics approval number [1]
304379
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NMRR-19-1345-47678
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Summary
Brief summary
Introduction: Pulmonary Tuberculosis (PTB) is still an important public health problem in Melaka. Limited research is carried out on the impact of the disease on the health-related quality of life (HRQoL). Family support intervention had been shown to be effective in improving the PTB treatment outcomes. Health economic evaluation was done to determine the cost-effectiveness of the family support intervention as compared to the conventional management.
Objectives: The aim of this study is to determine the cost-effectiveness of the family support education intervention in improving the quality of life (QoL) among PTB patients in Melaka.
Methodology: A single-blinded, randomized control trial study design, with health economic evaluation employing cost effectiveness analysis, will be conducted in Melaka from September 2018 until August 2021. The participants will be randomized into the intervention group and the control group. Both of them will be interviewed by using a pre-tested and validated questionnaire Short Form 36 Health Survey (SF-36). Data will be analyzed by using SPSS version 24. Normality test will be done for continuous variables. 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.
Expected Outcomes: The family support education intervention should improve the QoL of PTB patients. The intervention is expected to be more cost-effective in improving the QoL of PTB patients as compared with the conventional management.
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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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Dr Mohamad Syafiq Mohamad Saidi
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Address
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Universiti Putra Malaysia (UPM),
Serdang, 43400 Seri Kembangan,
Selangor, Malaysia.
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Country
96754
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Malaysia
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Phone
96754
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+60193499996
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Fax
96754
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Email
96754
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[email protected]
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Contact person for public queries
Name
96755
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Dr Mohamad Syafiq Mohamad Saidi
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Address
96755
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Universiti Putra Malaysia (UPM),
Serdang, 43400 Seri Kembangan,
Selangor, Malaysia.
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Country
96755
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Malaysia
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Phone
96755
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+60193499996
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Fax
96755
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Email
96755
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[email protected]
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Contact person for scientific queries
Name
96756
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A/Prof Muhamad Hanafiah Juni
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Address
96756
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Universiti Putra Malaysia (UPM),
Serdang, 43400 Seri Kembangan,
Selangor, Malaysia.
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Country
96756
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Malaysia
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Phone
96756
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+60136215276
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Fax
96756
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Email
96756
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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)?
Yes
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What data in particular will be shared?
Published results only
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When will data be available (start and end dates)?
Immediately after publication, and no end date.
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Available to whom?
Anyone interested with the research
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Available for what types of analyses?
Related with the research
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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.
[email protected]
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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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