Xin Ye1,2, Dawei Zhu2, Siyuan Chen1,2, Xuefeng Shi3,4, Rui Gong5, Juncheng Wang6, Huibin Zuo6, Mei Zhang7, Ping He8. 1. School of Public Health, Peking University, Beijing, China. 2. China Center for Health Development Studies, Peking University, Beijing, China. 3. School of Management, Beijing University of Chinese Medicine, Beijing, China. 4. National Institute of Chinese Medicine Department and Strategy, Beijing University of Chinese Medicine, Beijing, China. 5. China Rehabilitation Research Center for Hearing and Speech Impairment, Beijing, China. 6. Linyi Center for Disease Control and Prevention, Linyi, Shandong, China. 7. Linyi Rehabilitation Hospital, Linyi, Shandong, China. 8. China Center for Health Development Studies, Peking University, Beijing, China. phe@pku.edu.cn.
Abstract
BACKGROUND:Hearing loss is quite prevalent and can be related to people's quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. METHODS/ DESIGN: In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. DISCUSSION: The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900024739 . Registered on 26 July 2019.
RCT Entities:
BACKGROUND:Hearing loss is quite prevalent and can be related to people's quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. METHODS/ DESIGN: In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. DISCUSSION: The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900024739 . Registered on 26 July 2019.
Entities:
Keywords:
Community-based rehabilitation; Hearing loss; Randomized controlled trial; Study protocol
Authors: David Hartley; Elena Rochtchina; Philip Newall; Maryanne Golding; Paul Mitchell Journal: J Am Acad Audiol Date: 2010 Nov-Dec Impact factor: 1.664
Authors: Adrian Davis; Catherine M McMahon; Kathleen M Pichora-Fuller; Shirley Russ; Frank Lin; Bolajoko O Olusanya; Shelly Chadha; Kelly L Tremblay Journal: Gerontologist Date: 2016-04