| Background:Frailty and cognitive impairment are major challenges in the process of population aging in China.Compared with only physical frailty or mild cognitive impairment,cognitive frailty increases the risk of dementia,disability,falls and depression in the elderly.Therefore,early identification and intervention for people with a higher risk of cognitive frailty could more effectively reduce adverse health outcomes in the elderly.The incidence of hearing loss in the elderly was as high as 52.70%to 80.00%.Previous studies pointed out that hearing loss was an independent factor of frailty and cognitive impairment.Still,few studies explored the relationship between hearing loss and cognitive frailty,and there was also a lack of studies on hearing intervention in the elderly with cognitive frailty.Objectives:(1)To explore the association of hearing loss with the risk of cognitive frailty in the elderly and the dose-response relationship between them.(2)To evaluate the effect of over-the-counter(OTC)hearing aids and their health education on cognitive function and frailty of the elderly with hearing loss and cognitive frailty,and the health economy of the intervention program.Methods:This study consisted of two parts.Part 1:A cross-sectional study was conducted.Convenience sampled and included 432 community-based elderly people aged 65 years or older.The hearing loss was objectively measured using a hearing software based on pure tone audiometry,and selfperceived hearing loss was assessed by the Hearing Handicap Inventory for the ElderlyScreening(HHIE-S).Cognitive frailty was assessed using the Fried Phenotype,Montreal Cognitive Assessment,Subjective Cognitive Decline Questionnaire 9,and Clinical Dementia Rating Scale.The general data and other main factors of cognitive frailty were also investigated.Unordered multinomial logistic regression was used to explore the association of hearing loss with the risk of cognitive frailty in the elderly.Then,linear trend tests and restricted cubic splines were used to examine the dose-response relationship between them.Part 2:First,based on the guidelines and health belief model,the first draft of the hearing intervention was formed after discussion by the research group and experts.After that,ten experts were invited to revise the framework and content of the intervention by the Delphi method to form the final hearing intervention.Second,a non-randomized concurrent controlled trial was conducted.Seventy elderly people with cognitive frailty and mild or moderate sensorineural hearing loss in both ears were enrolled.The intervention group received health education on hearing aids and OTC hearing aids wearing at least 4 hours a day.The control group was provided with health education brochures for age-related hearing loss.The duration of the intervention was three months.The global cognitive function,frailty,each domain of the cognitive function,subjective cognitive decline,physical function and self-perceived hearing loss in the two groups were measured before the intervention,one month after the intervention and three months after the intervention.The difference between the two groups was compared by independent sample t-test,Mann-Whitney U test,chi-square test or Fisher’s exact probability test.At the same time,from the perspective of the whole society,cost-utility analysis was used to evaluate the health economy of hearing intervention through cost calculation,utility calculation and calculation of incremental cost-utility ratio.ResultsPart 1:The incidence of reversible cognitive frailty was 22.92%and the incidence of potentially reversible cognitive frailty was 30.78%in 432 subjects.The median and interquartile range of pure tone average(PTA)in the better ear and HHIE-S were 32.50(25.00,38.75)dB HL and 0(0,4.00)points,respectively.For reversible cognitive frailty,the model fully adjusted for confounding factors showed that compared with the elderly without cognitive frailty,PTA of the better ear,degree of hearing loss,and HHIE-S score were not associated with the risk of reversible cognitive frailty(P>0.05).In addition,both trend analysis and restricted cubic spline results showed no significant dose-response relationship between hearing loss and reversible cognitive frailty.For potentially reversible cognitive frailty,the model fully adjusted for confounding factors showed that for every 1 dB increase in PTA in the better ear,there was a 4%(95%CI:1%～12%,P=0.005)increased risk of potentially reversible cognitive frailty compared to the elderly without cognitive frailty.When the PTA of the better ear was classified as categorical variables,the results showed that the risk of potentially reversible cognitive frailty in the elderly with mild hearing loss,moderate or severe hearing loss was 2.33 times(95%CI:1.21～4.51)and 3.06 times 95%(CI:1.36～6.90)higher than that in the normal hearing group,respectively.All of them were statistically significant(P=0.012 and P=0.007).The trend test was also statistically significant(Ptrend=0.017).The results of the restricted cubic spline showed that PTA in the better ear showed a meaningful linear increasing dose-response relationship with the risk of potentially reversible cognitive frailty(Poverall=0.023,Pnon-linear=0.281).However,there was no statistically significant association between HHIE-S scores and the risk of potentially reversible cognitive frailty(P=0.167),nor was there a significant dose-response relationship(Poverall=0.057).Part 2:Through two rounds of Delphi surveys,a hearing intervention consisting of OTC hearing aids selection and wearing and hearing aids health education was formed.The intervention included two first-level items,nine second-level items,and 15 third-level items.63 subjects(30 in the intervention group and 33 in the control group)completed all interventions and follow-up visits and met the minimum hearing aids-wearing time requirements.(1)Comparison between groups at each time point before and after intervention:The scores of frailty,language function and self-perceived hearing loss in the intervention group were significantly higher than those in the control group(P<0.05).The global cognitive function score of the intervention group was significantly higher than that of the control group at one month after intervention(P<0.05),but there was no significant difference between the two groups at three months after intervention(P>0.05).However,there was no significant difference in memory,attention and working memory,executive function,subjective cognitive decline,and physical function between the two groups at each time point(P>0.05).(2)Cost-utility analysis:The incremental cost-utility ratios between the intervention group and the control group were (?) 21017.74/QALY and(?) 40475.74/QALY at one month and three months after the intervention,respectively,which indicated that the intervention group needed to spend (?) 21017.74 and (?) 40475.74 more per quality adjusted life years than the control group.Because the incremental costutility ratio is lower than the willingness to pay threshold((?) 82204)in China,the hearing intervention has good cost-utility.Conclusions:(1)Objective hearing loss based on pure tone audiometry significantly increased the risk of potentially reversible cognitive frailty.Furthermore,there was a significant linear dose-response relationship between hearing loss and the risk of potentially reversible cognitive frailty,but there was no significant relationship between hearing loss measured by the scale and potentially reversible cognitive frailty.No significant association was found between objective or scale-measured hearing loss and the risk of reversible cognitive frailty.(2)Hearing intervention consisting of OTC hearing aids and hearing aids health education can improve the global cognitive function of the elderly with cognitive frailty in the short-term,but its long-term effect needs to be verified by different and equivalent Montreal Cognitive Assessment versions.Moreover,hearing intervention can significantly improve the language function,frailty and self-perceived hearing loss of the elderly with cognitive frailty,but no significant improvement has been found in memory,attention and working memory,executive function,subjective cognitive decline and physical function.The hearing intervention has good cost-utility,so it can be promoted in the elderly with mild or moderate hearing loss and cognitive frailty in the community from the health economic point of view. |
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