JAMA Netw Open. 2024 Nov 4;7(11):e2446591. doi: 10.1001/jamanetworkopen.2024.46591.
ABSTRACT
IMPORTANCE: Health-related quality of life is a critical health outcome and a clinically important patient-reported outcome in clinical trials. Hearing loss is associated with poorer health-related quality-of-life in older adults.
OBJECTIVE: To investigate the 3-year outcomes of hearing intervention vs health education control on health-related quality of life.
DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of a randomized clinical trial included participants treated for hearing loss at multiple US centers between 2018 and 2019 with 3-year follow-up completed in 2022. Eligible participants were aged 70 to 84 years, had untreated hearing loss, and were without substantial cognitive impairment. Participants were randomized (1:1) to hearing intervention or health education control and followed every 6 months.
INTERVENTION: Hearing intervention (provision of hearing aids and related technologies, counseling, education) or health education control (individual sessions covering topics relevant to chronic disease, disability prevention).
MAIN OUTCOMES AND MEASURES: Three-year change in the RAND-36 physical and mental health component scores over 3 years. The 8 individual domains of health-related quality-of-life were additionally assessed. Outcomes measured at baseline and at 6-month, 1-year, 2-year, and 3-year follow-ups. Intervention effect sizes estimated using a 2-level linear mixed effects model under the intention-to-treat principle.
RESULTS: A total of 977 participants were analyzed (mean [SD] age, 76.8 [4.0] years; 523 female [53.5%]; 112 Black [11.5%], 858 White [87.8%]; 521 had a Bachelor’s degree or higher [53.4%]), with 490 in the hearing intervention and 487 in the control group. Over 3 years, hearing intervention (vs health education control) had no significant association with physical (intervention, -0.49 [95% CI, -3.05 to 2.08]; control, -0.92 [95% CI, -3.39 to 1.55]; difference, 0.43 [95% CI, -0.64 to 1.51]) or mental (intervention, 0.38 [95% CI, -1.58 to 2.34]; control, -0.09 [95% CI, -1.99 to 1.81]; difference, 0.47 [95% CI, -0.41 to 1.35]) health-related quality of life.
CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial, hearing intervention had no association with physical and mental health-related quality-of-life over 3 years among older adults with hearing loss. Additional intervention strategies may be needed to modify health-related quality among older adults with hearing loss.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03243422.
PMID:39570588 | DOI:10.1001/jamanetworkopen.2024.46591
