None listed
Conditions
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.
Interventions
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
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).
Sponsors
Malaysia Ministry of Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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)
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
Outcome results
None listed