Top

Trials

Published in:

Open Access 01-12-2021 | Study protocol

Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Authors: Xin Ye, Dawei Zhu, Siyuan Chen, Xuefeng Shi, Rui Gong, Juncheng Wang, Huibin Zuo, Mei Zhang, Ping He

Published in: Trials | Issue 1/2021

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.

Available only for authorised users

Looi LM, Ganten D, McGrath PF, Gross M, Griffin GE. Hearing loss: a global health issue. Lancet. 2015;385(9972):943–4. https://doi.org/10.1016/S0140-6736(15)60208-2.CrossRefPubMed

Feigin V. Global, regional, and National Incidence, prevalence, and years lived with disability for 310 acute and chronic diseases and injuries, 1990-2015: a systematic analysis for the global burden of disease study 2015. Lancet. 2016;388(10053):1545–602.CrossRef

Arlinger S. Negative consequences of uncorrected hearing loss—a review. Int J Audiol. 2003;42(sup2):17–20.CrossRef

GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1545–602.CrossRef

National Bureau of Statistics of the People’s Republic of China. The main data bulletin of the second national sampling survey for the disabled (Number 2). http://www.gov.cn/fuwu/cjr/2009-05/08/content_2630949.htm. Published 2009. Accessed 17 July 2019.

Zheng X. Research on disability prevention in China. Beijing: Huaxia Press; 2008.

West JS. Hearing impairment, social support, and depressive symptoms among U.S. adults: a test of the stress process paradigm. Soc Sci Med. 2017;192:94–101. https://doi.org/10.1016/j.socscimed.2017.09.031.CrossRefPubMed

World Health Organization. Deafness and Hearing Loss. https://www.who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss. Published 2020. Accessed 16 Nov 2020.

Kramer SE, Kapteyn TS, Kuik DJ, Deeg DJ. The association of hearing impairment and chronic diseases with psychosocial health status in older age. J Aging Health. 2002;14(1):122–37. https://doi.org/10.1177/089826430201400107.CrossRefPubMed

10.

Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003;43(5):661–8. https://doi.org/10.1093/geront/43.5.661.CrossRefPubMed

11.

Chew H, Yeak S. Quality of life in patients with untreated age-related hearing loss. J Laryngol Otol. 2010;124(8):835–41. https://doi.org/10.1017/S0022215110000757.CrossRefPubMed

12.

Hu X, Zheng X, Ma F, Long M, Han R, Zhou LJ, Wang F, Gong R, Pan T, Zhang SX, du B, Jin P, Guo CY, Zheng YQ, Liu M, He LH, Qiu JH, Xu M, Song L, Xu XH, Liu XW, Wang SP. Prevalence of hearing disorders in China: a population-based survey in four provinces of China. Chin J Otorhinolaryngol Head Neck Surg. 2016;51(11):819–25. https://doi.org/10.3760/cma.j.issn.1673-0860.2016.11.004.CrossRef

13.

Davis A, McMahon CM, Pichora-Fuller KM, et al. Aging and hearing health: the life-course approach. Gerontologist. 2016;56(Suppl 2):S256–67. https://doi.org/10.1093/geront/gnw033.CrossRefPubMedPubMedCentral

14.

Perez E, Edmonds BA. A systematic review of studies measuring and reporting hearing aid usage in older adults since 1999: a descriptive summary of measurement tools. PLoS One. 2012;7(3):e31831. https://doi.org/10.1371/journal.pone.0031831.

15.

Laplante-Lévesque A, Hickson L, Worrall L. Rehabilitation of older adults with hearing impairment: a critical review. J Aging Health. 2010;22(2):143–53. https://doi.org/10.1177/0898264309352731.CrossRefPubMed

16.

Laplante-Lévesque A, Hickson L, Worrall L. Predictors of rehabilitation intervention decisions in adults with acquired hearing impairment. J Speech Lang Hear Res. 2011;54(5):1385–99. https://doi.org/10.1044/1092-4388(2011/10-0116).

17.

Bridges JA, Bentler RA. Relating hearing aid use to well-being among older adults. Hear J. 1998;51(7):39–42. https://doi.org/10.1097/00025572-199807000-00002.CrossRef

18.

APPOLLONIO I, CARABELLESE C, FRATTOLA L, TRABUCCHI M. Effects of sensory aids on the quality of life and mortality of elderly people: a multivariate analysis. Age Ageing. 1996;25(2):89–96. https://doi.org/10.1093/ageing/25.2.89.CrossRefPubMed

19.

Hartley D, Rochtchina E, Newall P, Golding M, Mitchell P. Use of hearing aids and assistive listening devices in an older Australian population. J Am Acad Audiol. 2010;21(10):642–53. https://doi.org/10.3766/jaaa.21.10.4.CrossRefPubMed

20.

Chien W, Lin FR. Prevalence of hearing aid use among older adults in the United States. Arch Intern Med. 2012;172(3):292–3. https://doi.org/10.1001/archinternmed.2011.1408.CrossRefPubMedPubMedCentral

21.

Chang H-P, Chou P. Presbycusis among older Chinese people in Taipei, Taiwan: a community-based study. Int J Audiol. 2007;46(12):738–45. https://doi.org/10.1080/14992020701558529.CrossRefPubMed

22.

Barnett M, Hixon B, Okwiri N, Irungu C, Ayugi J, Thompson R, Shinn JB, Bush ML. Factors involved in access and utilization of adult hearing healthcare: a systematic review. Laryngoscope. 2017;127(5):1187–94. https://doi.org/10.1002/lary.26234.CrossRefPubMed

23.

He P, Wen X, Hu X, Gong R, Luo Y, Guo C, Chen G, Zheng X. Hearing aid acquisition in Chinese older adults with hearing loss. Am J Public Health. 2018;108(2):241–7. https://doi.org/10.2105/AJPH.2017.304165.CrossRefPubMedPubMedCentral

24.

Nordvik Ø, Heggdal POL, Brännström J, Vassbotn F, Aarstad AK, Aarstad HJ. Generic quality of life in persons with hearing loss: a systematic literature review. BMC Ear Nose Throat Disord. 2018;18(1):1.CrossRefPubMedPubMedCentral

25.

Joore MA, Brunenberg DE, Chenault MN, Anteunis LJ. Societal effects of hearing aid fitting among the moderately hearing impaired: Efectos sociales de la adaptación de auxiliares auditivos en pacientes con impedimentos auditivos moderados. Int J Audiol. 2003;42(3):152–60. https://doi.org/10.3109/14992020309090424.CrossRefPubMed

26.

Joore MA, Potjewijd J, Timmerman A, Anteunis L. Response shift in the measurement of quality of life in hearing impaired adults after hearing aid fitting. Qual Life Res. 2002;11(4):299–307. https://doi.org/10.1023/A:1015598807510.CrossRefPubMed

27.

Stark P, Hickson L. Outcomes of hearing aid fitting for older people with hearing impairment and their significant others. Int J Audiol. 2004;43(7):390–8. https://doi.org/10.1080/14992020400050050.CrossRefPubMed

28.

Valentijn SA, Van Boxtel MP, Van Hooren SA, et al. Change in sensory functioning predicts change in cognitive functioning: results from a 6-year follow-up in the Maastricht Aging Study. J Am Geriatr Soc. 2005;53(3):374–80. https://doi.org/10.1111/j.1532-5415.2005.53152.x.CrossRefPubMed

29.

Collins MP, Liu C-F, Taylor L, Souza PE, Yueh B. Hearing aid effectiveness after aural rehabilitation: Individual versus group trial results. J Rehabil Res Dev. 2013;50(4):585–98. https://doi.org/10.1682/jrrd.2012.03.0049.

30.

Carlsson P-I, Hjaldahl J, Magnuson A, Ternevall E, Edén M, Skagerstrand Å, Jönsson R. Severe to profound hearing impairment: quality of life, psychosocial consequences and audiological rehabilitation. Disabil Rehabil. 2015;37(20):1849–56. https://doi.org/10.3109/09638288.2014.982833.CrossRefPubMed

31.

Chen DS, Genther DJ, Betz J, Lin FR. Association between hearing impairment and self-reported difficulty in physical functioning. J Am Geriatr Soc. 2014;62(5):850–6. https://doi.org/10.1111/jgs.12800.CrossRefPubMedPubMedCentral

32.

Acar B, Yurekli MF, Babademez MA, Karabulut H, Karasen RM. Effects of hearing aids on cognitive functions and depressive signs in elderly people. Arch Gerontol Geriatr. 2011;52(3):250–2. https://doi.org/10.1016/j.archger.2010.04.013.CrossRefPubMed

33.

Boi R, Racca L, Cavallero A, Carpaneto V, Racca M, Dall' Acqua F, Ricchetti M, Santelli A, Odetti P. Hearing loss and depressive symptoms in elderly patients. Geriatr Gerontol Int. 2012;12(3):440–5. https://doi.org/10.1111/j.1447-0594.2011.00789.x.CrossRefPubMed

34.

Chi I, Yip PS, Chiu HF, et al. Prevalence of depression and its correlates in Hong Kong’s Chinese older adults. Am J Geriatr Psychiatry. 2005;13(5):409–16. https://doi.org/10.1097/00019442-200505000-00010.CrossRefPubMed

35.

Ventry IM, Weinstein BE. The hearing handicap inventory for the elderly: a new tool. Ear Hear. 1982;3(3):128–34. https://doi.org/10.1097/00003446-198205000-00006.CrossRefPubMed

36.

Cox R, Hyde M, Gatehouse S, Noble W, Dillon H, Bentler R, Stephens D, Arlinger S, Beck L, Wilkerson D, Kramer S, Kricos P, Gagné JP, Bess F, Hallberg L. Optimal outcome measures, research priorities, and international cooperation. Ear Hear. 2000;21(4 Suppl):106S–15S. https://doi.org/10.1097/00003446-200008001-00014.CrossRefPubMed

37.

Chisolm TH, Johnson CE, Danhauer JL, Portz LJ, Abrams HB, Lesner S, McCarthy P, Newman CW. A systematic review of health-related quality of life and hearing aids: final report of the American Academy of Audiology Task Force on the Health-Related Quality of Life Benefits of Amplification in Adults. J Am Acad Audiol. 2007;18(2):151–83. https://doi.org/10.3766/jaaa.18.2.7.CrossRefPubMed

38.

Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586. https://doi.org/10.1136/bmj.e7586.CrossRefPubMedPubMedCentral

39.

McCoy CE. Understanding the intention-to-treat principle in randomized controlled trials. West J Emerg Med. 2017;18(6):1075–8. https://doi.org/10.5811/westjem.2017.8.35985.CrossRefPubMedPubMedCentral

40.

Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8(1):18. https://doi.org/10.1186/1741-7015-8-18.CrossRefPubMedPubMedCentral

41.

Cieza A, Oberhauser C, Bickenbach J, Chatterji S, Stucki G. Towards a minimal generic set of domains of functioning and health. BMC Public Health. 2014;14(1):218. https://doi.org/10.1186/1471-2458-14-218.CrossRefPubMedPubMedCentral

42.

Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159–63.CrossRefPubMedPubMedCentral

43.

Wilding S, Conner M, Sandberg T, Prestwich A, Lawton R, Wood C, Miles E, Godin G, Sheeran P. The question-behaviour effect: a theoretical and methodological review and meta-analysis. Eur Rev Soc Psychol. 2016;27(1):196–230. https://doi.org/10.1080/10463283.2016.1245940.CrossRef

Title: Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial
Authors: Xin Ye
Dawei Zhu
Siyuan Chen
Xuefeng Shi
Rui Gong
Juncheng Wang
Huibin Zuo
Mei Zhang
Ping He
Publication date: 01-12-2021
Publisher: BioMed Central
Published in: Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05228-2

At a glance: The STEP trials

Springer Medicine

Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2021

Adding a smartphone app to global postural re-education to improve neck pain, posture, quality of life, and endurance in people with nonspecific neck pain: a randomized controlled trial

Correction to: MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers

Protocol for the Metformin Aneurysm Trial (MAT): a placebo-controlled randomised trial testing whether metformin reduces the risk of serious complications of abdominal aortic aneurysm

The effect of omega-3 long chain polyunsaturated fatty acids on aggressive behaviour in adult male prisoners: a structured study protocol for a multi-centre, double-blind, randomised placebo-controlled trial and translation into policy and practice

Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial