Ministry of Health, Putrajaya, Malaysia.
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.
BMC Pulm Med. 2023 Apr 25;23(1):139. doi: 10.1186/s12890-023-02440-5.
Pulmonary Tuberculosis (PTB) is an important public health problem in Malaysia. In this country, limited research has been carried out on the impact of the disease on the health-related quality of life (HRQoL). Family support interventions had been shown to be effective in improving the PTB treatment outcomes.
This study aims to determine the effectiveness of a newly developed Family Support Health Education (FASTEN) intervention in improving the health-related quality of life (HRQoL) among PTB patients in Melaka, as compared to the current conventional disease management.
A single-blinded, randomized controlled field trial study design was conducted in Melaka from September 2019 until August 2021, involving newly diagnosed PTB patients. The participants were randomized either into the intervention group (FASTEN intervention) or into the control group (conventional management). They were interviewed by using a validated questionnaire that includes the Short Form 36 Health Survey version 2 (SF-36v2), at three time points: at diagnosis, two months and six months after diagnosis. Data were analyzed using IBM SPSS Statistics for Windows version 24. The Generalized Estimating Equations (GEE) analysis was used to evaluate the effectiveness of the intervention, in terms of the HRQoL score difference between the groups, adjusted for baseline covariates.
The HRQoL among PTB patients was lower than the HRQoL of general Malaysian population. Among the total 88 respondents, the three lowest HRQoL domains scores at baseline were Social Functioning (SF), Role limitation due to Physical condition (RP) and Vitality (VT) with the median (IQR) scores of 27.26 (10.03), 30.21 (11.23) and 34.77 (8.92) respectively. The median (IQR) for Physical Component Score (PCS) was 43.58 (7.44) and for Mental Component Score (MCS) was 40.71 (8.77). There were significant difference in the HRQoL median scores between the intervention group compared to the control group, as the Physical Functioning (PF) (p = 0.018), RP (p < 0.001), General Health (GH) (p < 0.001), VT (p < 0.001), SF (p < 0.001), Role limitation due to Emotional condition (RE) (p < 0.001), General Mental Health (MH) (p < 0.001), and the MCS (p < 0.001).
The FASTEN intervention is effective to improve the overall HRQoL among PTB patients, as the HRQoL scores were significantly higher in the intervention group compared to the control group who received conventional management. Therefore, it is recommended that the TB program should incorporate the involvement of family members in the patient's management.
The protocol was registered with RCT registered body on 05/12/2019 (Australian New Zealand Clinical Trial Registry - Registration Number: ACTRN12619001720101).
肺结核（PTB）是马来西亚一个重要的公共卫生问题。在该国，对该疾病对健康相关生活质量（HRQoL）的影响的研究有限。家庭支持干预已被证明能有效改善肺结核的治疗效果。
本研究旨在确定新开发的家庭支持健康教育（FASTEN）干预措施在改善马六甲肺结核患者的健康相关生活质量（HRQoL）方面的有效性，与当前的常规疾病管理相比。
这是一项在 2019 年 9 月至 2021 年 8 月期间在马六甲进行的单盲、随机对照现场试验研究，涉及新诊断的肺结核患者。参与者被随机分为干预组（FASTEN 干预）或对照组（常规管理）。他们在三个时间点接受了经过验证的问卷采访，包括简短形式 36 健康调查版本 2（SF-36v2）：诊断时、诊断后两个月和六个月。使用 IBM SPSS Statistics for Windows 版本 24 分析数据。使用广义估计方程（GEE）分析来评估干预的有效性，以组间 HRQoL 评分差异为指标，调整基线协变量。
肺结核患者的 HRQoL 低于一般马来西亚人口的 HRQoL。在 88 名总应答者中，基线时三个最低的 HRQoL 领域评分是社会功能（SF）、身体状况引起的角色限制（RP）和活力（VT），中位数（IQR）分别为 27.26（10.03）、30.21（11.23）和 34.77（8.92）。身体成分评分（PCS）的中位数（IQR）为 43.58（7.44），心理成分评分（MCS）为 40.71（8.77）。干预组与对照组之间的 HRQoL 中位数评分存在显著差异，身体功能（PF）（p=0.018）、RP（p<0.001）、一般健康（GH）（p<0.001）、VT（p<0.001）、SF（p<0.001）、情绪状况引起的角色限制（RE）（p<0.001）、一般心理健康（MH）（p<0.001）和 MCS（p<0.001）。
FASTEN 干预措施有效改善了肺结核患者的整体 HRQoL，因为干预组的 HRQoL 评分明显高于接受常规管理的对照组。因此，建议结核病规划应将家庭成员纳入患者的管理中。
该方案于 2019 年 12 月 5 日在 RCT 注册机构注册（澳大利亚新西兰临床试验注册中心 - 注册号：ACTRN12619001720101）。
