Hearing Aids + Health Education for Age-Related Hearing Loss
(EARHLI Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJustin S Golub, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Congenital hearing loss, Dementia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Hearing Aids + Health Education for Age-Related Hearing Loss?
Research shows that educational programs, like multimedia-based education, can improve knowledge and self-confidence in managing hearing aids, which helps people use them more effectively. Additionally, collaboration between healthcare providers and home services can enhance practical skills and satisfaction with hearing aid use.
12345Is the combination of hearing aids and health education safe for humans?
The available research on health education programs, including those for older adults, suggests they are generally safe and focus on improving knowledge and behavior related to health. There is no specific safety data on the combination of hearing aids and health education, but health education interventions are typically non-invasive and safe.
678910How is the Hearing Aids + Health Education treatment for age-related hearing loss different from other treatments?
This treatment is unique because it combines hearing aids with a health education program, which helps users understand and effectively use their hearing aids, improving communication skills and overall quality of life. Unlike traditional treatments that focus solely on fitting hearing aids, this approach includes educational resources and communication strategies to address the broader challenges of hearing loss.
1112131415Eligibility Criteria
The EARHLI trial is for late middle-aged adults who are experiencing early age-related hearing loss and may be at risk for cognitive decline or Alzheimer's Disease. Participants will be followed for a year to see if interventions help.Inclusion Criteria
Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear
I have someone who can help with my study-related assessments.
I am between 55 and 75 years old.
+5 more
Exclusion Criteria
Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)
Unwillingness to wear hearing aids regularly (≥8 hours/day)
Medical contraindications to the use of hearing aids (e.g., actively draining ear)
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to either a hearing intervention or a health education intervention. The hearing intervention includes 4 sessions across 8 weeks with a booster session and hearing aid fitting.
8 weeks
4 visits (in-person)
Follow-up
Participants are monitored for cognitive decline, social engagement, and changes in brain organization/connectivity. Assessments occur at study start, 6 months, and 12 months.
1 year
3 visits (in-person)
Extension
Participants in the health education group receive hearing aids at the end of their 12-month participation.
End of study
Participant Groups
This study tests whether providing hearing aids (hearing intervention) can reduce cognitive decline compared to just receiving health education. Adults in the trial will receive one of these two interventions randomly.
2Treatment groups
Experimental Treatment
Group I: Hearing InterventionExperimental Treatment1 Intervention
Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take \~75 minutes.
Group II: Health Education InterventionExperimental Treatment1 Intervention
Participants will receive a modified health education program on healthy aging. It will match the number and length of sessions as the hearing intervention, including compliance/phone checks. Participants will be on a waitlist to obtain hearing aids without fee at the end of their 12-month participation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
University of WashingtonCollaborator
National Institute on Aging (NIA)Collaborator
University of South FloridaCollaborator
University of PittsburghCollaborator
Johns Hopkins UniversityCollaborator
References
Information Retention and Overload in First-Time Hearing Aid Users: An Interactive Multimedia Educational Solution. [2022]An educational intervention to improve knowledge of hearing aids and communication in first-time hearing aid users was assessed. This intervention was based on the concept of reusable learning objects (RLOs).
Improving self-efficacy for hearing aid self-management: the early delivery of a multimedia-based education programme in first-time hearing aid users. [2021]Objectives: This study examined the effect of a multimedia educational programme for first-time hearing aid users (C2Hear reusable learning objects, RLOs), delivered at the hearing assessment on (1) self-efficacy for hearing aids (primary outcome), and (2) readiness for hearing rehabilitation and hearing aid knowledge (secondary outcomes).Design: A single-centre, prospective, pre-post, randomised controlled trial with two arms. The intervention group (n = 24) received RLOs, and the waitlist control group (n = 23) received a printed booklet on hearing aids. Outcomes were measured at the hearing assessment and hearing aid fitting appointments.Study sample: Fifty-six adult first-time hearing aid users attending a publicly funded audiology service.Results: The RLO group showed significantly greater improvement in self-efficacy and knowledge of hearing aids than the control group. A borderline effect of readiness for hearing rehabilitation was also found. Potential links between hearing aid self-efficacy and knowledge were identified.Conclusions: Early delivery of the RLOs results in greater hearing aid self-efficacy and knowledge at the hearing aid fitting appointment, with indications that RLOs increase readiness for hearing rehabilitation. As knowledge, self-efficacy and readiness are cornerstones of self-management, the C2Hear RLOs can prime first-time hearing aid users to better self-manage their hearing aids before they receive them.
[Hearing in a geriatric perspective]. [2015]To assess whether hearing rehabilitation of older people can be improved by co-operation between the audiology and geriatric departments and the home service, 139 old and frail audiological patients were allocated to three groups with three different fitting procedures: 1) conventional fitting including verification of acoustical gain in the patient's ear; 2) home-fitting by hearing therapists, and 3) home-fitting by a specially trained geriatric nursing assistant, the home help also being present. Outcome was assessed by the ordinary questionnaire mailed to hearing aids users three to four months after fitting and by a geriatric evaluation procedure. The response rate in the conventionally fitted group was highly unsatisfactory (36%) and too small for further data-analysis. In the educational group a tendency was found towards better manipulation skills and significantly higher hearing aid use. However, the response rate was lower than in the geriatric group (71% compared to 81%), and no knowledge of hearing aid use was registered in the home service by this procedure. In the geriatric group a correlation was found between practical ability and use and satisfaction with the hearing aid. However, two thirds of the group were dependent on lasting help for the handling of the aid. Most patients in this group were already known by the hospital and home service, and the individual home help showed an interest in learning about hearing aid use. Home fitting by a joint audiological and geriatric effort in collaboration with the home help has proven feasible and valuable to both patient and home help. Extended co-operation is recommended between the health care and the social sector concerning hearing aid use.
Decreased use of hearing aids following training in hearing tactics. [2018]In this report data on hearing aid use were combined from three randomized controlled studies on behavioural hearing tactics. Daily average hearing aid use at pretreatment and posttreatment were analysed for 63 older hearing-impaired persons who had either received treatment or acted as controls. Analysis showed a significant, albeit weak, decrease in daily hearing aid use for those subjects who had received the treatment. The utility of amount of hearing aid use as an indicator of rehabilitation success is discussed.
The successful hearing aid user. [2000]Improvements and modifications in design, construction, evaluation, and application procedures with the wearable hearing aid have brought the benefits of successful hearing aid use to an ever increasing proportion of the hearing impaired population. Many of today's successful hearing aid users would have been regarded at one time as extremely poor risks for hearing aid use. As a consequence, many of the prognostic principles developed as guidelines in advising for or against hearing aid trial are no longer true and should be discarded. Every person who experiences difficulties related to a permanent hearing impairment, no matter how slight or severe hearing loss, should have access to aural rehabilitation, including the use of wearable amplication.
[Health education. Educational approach to change]. [2019]There is currently a widespread interest in health education and a need to better understand the bases of the educational approach to health problems. This paper examines therefore some concepts and methods underlying health education work. It is important that health education objectives are closely related to the effects of human behaviour (what people do for their health) on health outcomes. One can, for example, identify health behaviours which are consequential to health promotion, disease prevention and health care utilization. They provide a focus for educational interventions. Secondly, the strategy of health education is based on the assumption that health practices (or their underlying factors) are subject to change through educational and information methods. This health education is essentially a process of change through education and may involve a more general process of educating the public for health, or a more specific attempt at modifying particular health practices. Applying health education to health problems requires an understanding of the communication process and its components. A number of characteristics which may facilitate or hinder communication are discussed. Finally, health education is more than a services of unstructured influences on people's behaviour. It is a planned strategy involving several stages of change. Also, to be fully effective, health education interventions should be integrated in health programmes and services together with other public health mesures.
Informing older adults about non-hazardous, hazardous, and harmful alcohol use. [2019]Low levels of alcohol may be hazardous in the elderly, but available education focuses on younger, abusive, and dependent drinkers. A total of 209 older persons participated in various components of the development and evaluation of 'A Toast To Health In Later Life!' health promotion materials for the elderly. Patient focus groups, physicians, educators, and alcohol-use researchers contributed to all materials and measures. An education model for older adults guided the instructional format. Knowledge and self-efficacy scores increased significantly from pre- to post-test. Over 45% of persons in selected senior centers reviewed the materials without prompting by the study team. Older adults are willing to read extensively about the relationships among drinking, health, and medication use. Patient educators should include consumers in the design of health promotion materials and measures. Practitioners who rely on written educational materials for patient education and counseling should be provided with evidence of appropriateness, effectiveness, and feasibility.
Does patient education in chronic disease have therapeutic value? [2019]A pool of 320 articles on patient education were screened to select controlled experiments in chronic disease where the dependent variables included (a) compliance with therapeutic regimen, (b) physiological progress of patients or (c) long-range outcome. Thirty such articles were found; and the magnitude of experimental effects of patient education were calculated using an empirical form of integrating research findings known as meta-analysis. Summary of all experimental effects showed patient education most successful in altering compliance (average improvement = 0.67 sigma over control, p less than 0.05). However, average improvements in physiological progress (0.49 sigma) and health outcome (0.02 sigma) were also statistically significant (p less than 0.01 and p less than 0.05, respectively). Efforts to improve health by increasing patient knowledge alone were rarely successful. Behaviorally-oriented program, often with special attention to changing the environment in which patients care for themselves, were consistently more successful at improving the clinical course of chronic disease.
Interest in participation in a peer-led senior health education program. [2019]A study was made of the characteristics of older adults showing an interest in participating in a health education course given by peers. Determining the degree of interest in health education is important for assessing the impact on the target-population and evaluating the dissemination strategy. In the course 'Successful Aging' groups of older adults came together to discuss health related issues. The course was given by senior health educators aged 55 years and over from the peer group. To determine interest in the course answer cards were sent with a letter of invitation to all independently living inhabitants aged between 55 an 79 in a Dutch community. The rate of expressed interest in the course was 5.8%. Interest was highest among females in the 55-64 age group, the unmarried and those with low wellbeing. Males in the age group 65-79, females aged 75-79, those with a lower socio-economic status and the inactive were comparatively less interested. Subscription to the course was distinguished from mere interest in the course. From those who expressed interest, more people of low socio-economic status, with a reduced level of wellbeing, many physical limitations and poor self-efficacy actually subscribed. It is concluded that the health education program will be continued and that special attention will be paid to groups that showed lower levels of uptake. Involving intermediates from these groups in the course development is recommended.
[Education program for cardiac rehabilitation: Impact of the "Drugs" multidisciplinary workshop on the patients' knowledge in the short- and long-term]. [2021]The aim of this study is to assess the impact of the "Drugs" workshop of a therapeutic education program for cardiac rehabilitation on the patients' knowledge in the short and long term.
Beyond hearing aid fitting: improving communication for older adults. [2015]Many older adults with hearing impairment continue to have substantial communication difficulties after being fitted with hearing aids, and many do not choose to wear hearing aids. Two group communication education programs aimed at such older people are described. The 'Keep on Talking' program has a health promotion focus, and is aimed at maintaining communication for older adults living in the community. An experimental group (n = 120) attended the program, and a control group (n = 130) received a communication assessment but no intervention. Significant improvements were found in the experimental participants in terms of knowledge about communication changes with age and about strategies to maintain communication skills. At the follow-up evaluation at 1 year, 45% of the experimental group, compared to 10% of the control group, had acted to improve their communication skills. The 'Active Communication Education' program focuses on the development of problem-solving strategies to improve communication in everyday life situations. Preliminary outcomes have been assessed on a small scale (n = 14) to date. It is concluded that communication programs represent an important adjunct to, or supplement for, the traditional approach that focuses on hearing aid fitting.
A preliminary evaluation of the active communication education program in a sample of 87-year-old hearing impaired individuals. [2020]Previous research suggests that audiological rehabilitation for older adults could include group communication programs in addition to hearing aid fitting or as an alternative to hearing aid fitting for those people who do not wish to proceed with hearing aids. This pilot study was a first attempt to evaluate a Swedish version of such a program, Active Communication Education (ACE), which had been developed and previously evaluated in Australia (Hickson et al, 2007a).
Evaluating a Theoretically Informed and Cocreated Mobile Health Educational Intervention for First-Time Hearing Aid Users: Qualitative Interview Study. [2021]Adults living with hearing loss have highly variable knowledge of hearing aids, resulting in suboptimal use or nonuse. This issue can be addressed by the provision of high-quality educational resources.
[Auditory rehabilitation programmes for adults: what do we know about their effectiveness?]. [2014]Hearing loss ranks third among the health conditions that involve disability-adjusted life years. Hearing aids are the most commonly used treatment option in people with hearing loss. However, a number of auditory rehabilitation programmes have been developed with the aim of improving communicative abilities in people with hearing loss. The objective of this review was to determine the effectiveness of auditory rehabilitation programmes focused on communication strategies.
The Studying Multiple Outcomes After Aural Rehabilitative Treatment Study: Study Design and Baseline Results. [2020]Hearing loss may affect critical domains of health and functioning in older adults. This article describes the rationale and design of the Studying Multiple Outcomes After Aural Rehabilitative Treatment (SMART) study, which was developed to determine to what extent current hearing rehabilitative therapies could mitigate the effects of hearing loss on health outcomes. One hundred and forty-five patients ≥50 years receiving hearing aids (HA) or cochlear implants (CI) were recruited from the Johns Hopkins Department of Otolaryngology-HNS. A standardized outcome battery was administered to assess cognitive, social, mental, and physical functioning. Of the 145 participants aged 50 to 94.9 years who completed baseline evaluations, CI participants had significantly greater loneliness, social isolation, and poorer hearing and communicative function compared with HA participants. This study showed that standardized measures of health-related outcomes commonly used in gerontology appear sensitive to hearing impairment and are feasible to implement in clinical studies of hearing loss.