The effect of family-based participatory education on health-related quality of life in patients with pulmonary tuberculosis: a clinical trial

Pulmonary tuberculosis (TB) impairs respiratory function and significantly reduces health-related quality of life (HRQoL). Pharmacological treatments are essential but often insufficient to address patients’ psychosocial needs. This study evaluated the effect of a family-based participatory education program on HRQoL in patients with pulmonary TB. In this randomized controlled clinical trial conducted in 2024 in health centers affiliated with Mashhad University of Medical Sciences, eligible patients with pulmonary TB and their primary family caregivers were randomly assigned to either an intervention or control group. Participants were recruited via convenience sampling from public health centers. A total of 62 dyads (patients and their respective caregivers) were enrolled. The intervention group included 16 patients and 16 caregivers, while the control group comprised 15 patients and 15 caregivers. The intervention group received a structured family-participatory educational program (four face-to-face and two virtual sessions), while the control group received routine care. HRQoL was measured in patients using a validated 24-item TB-specific questionnaire covering physical, psychological, and social domains. Sample size was determined to ensure adequate statistical power to detect meaningful differences in HRQoL. Data were analyzed using SPSS version 26. Baseline HRQoL scores were comparable. Post-intervention, the intervention group showed significantly higher HRQoL scores than the control group (P < 0.001; mean change 16.6 vs. 2.1) across all domains. Family-based participatory education significantly improves HRQoL in pulmonary TB patients. Integrating such programs into TB care may enhance treatment adherence, reduce psychosocial burden, and improve long-term outcomes. Trial registration IRCT20220223054111N1, registered February 25, 2024.