Effectiveness of a Smart Hearing Aid on Improving Psychosocial Well-being in Elderly

NCT05772949 | Completed

• 1 other identifier: hearing_aid_protocol_v1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

The study has 2 primary research questions, 4 secondary research questions, and 2 auxiliary research questions targeting elderly with hearing impairment. The research questions are: Primary study questions:

1. 1.Can the use of the smart hearing aids reduce loneliness at the end of intervention?
2. 2.Can the use of the smart hearing aids improve quality of life at the end of intervention?
3. 3.Can the use of the smart hearing aids improve the communication quality between caregivers and participants at the end of intervention?
4. 4.How is the satisfaction of the participants with the smart hearing aids?
5. 5.What are the factors leading to the use and non-use of the smart hearing aids?
6. 6.What is the usage time of the smart hearing aids?
7. 7.How is the caregiver burden when facilitating the participants to use the smart hearing aids?
8. 8.What are the perceived benefits and acceptability of the smart hearing aids?

Conditions

Technology

Keywords

Gerontechnology; Hearing impairment; Hearing aid

Outcome Measures

Primary Outcomes (2)

• 6-week change in loneliness after using the smart hearing aids for 6 weeks

  Change of loneliness after using the smart hearing aids for 6 weeks will be measured by UCLA Loneliness Scale 3 items (UCLA 3-items, Russell et al., 1980; Liu et al., 2020). The minimum and maximum values of the scale are 3 and 9 respectively, with higher score indicating higher level of loneliness.

  Baseline, the 6th week and the 14th week (waitlist control group only)

• 6-week change in quality of life after using the smart hearing aids for 6 weeks

  Change in quality of life after using the smart hearing aids for 6 weeks will be measured by World Health Organization Quality of Life Brief Version (WHOQOL-BREF, World Health Organization, 2004).The minimum and maximum values of the scale are 26 and 130 respectively, with higher score indicating poorer quality of life.

  Baseline, the 6th week and the 14th week (waitlist control group only)

Secondary Outcomes (7)

• 6-week change in communication quality between participants and caregivers

  The 1st week, the 3rd week and the 6th week of using the smart hearing aids

• 6-week change in the elders' satisfaction after using the smart hearing aids for 6 weeks

  Baseline, the 6th week and the 14th week (waitlist control group only)

• Qualitative Measure: Factors leading to the use and non-use of the smart hearing aids during the 6-week trial period

  The 1st week, the 3rd week and the 6th week of using the smart hearing aids

• The usage time of the smart hearing aids during the 6-week trial period

  The 1st week, the 3rd week and the 6th week of the trial period

• 6-week change in caregivers burden while facilitating the use of the smart hearing aids

  The 1st week, the 3rd week and the 6th week of the trial period

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will use the smart hearing aid for 6 weeks.

Device: Experimental group intervention

Wait-list control group

EXPERIMENTAL

The wait-list control group will follow existing practice (i.e. using no hearing aids or using hearing aids other than the smart hearing aids) for 6 weeks and then use the smart hearing aids for 6 weeks.

Device: Wait-list control group intervention

Interventions

Experimental group intervention DEVICE

The caregivers will calibrate the smart hearing aids for the participants in the experimental group at the first day of week 1 through the designated mobile application. Caregivers will help the participants to choose the amplification level which best suits their needs. Participants in the experimental group can use the smart hearing aids whenever they want during the trial period (i.e. from week 1 to week 6). For participants living in residential setting, caregivers will facilitate them to use the smart hearing aids upon request from the participants or when the caregivers deem the aids beneficial. For participants living in community setting, they will use the smart hearing aids when needed. Their caregivers shall provide assistance in facilitating the participants to use the smart hearing aids. The smart hearing aids do not require any payment from the study participants. They have to return the hearing aids after the study.

Experimental group

Wait-list control group intervention DEVICE

The caregivers will calibrate the smart hearing aids for the participants in the wait-list control group at week 8 through the designated mobile application. Caregivers will help the participants to choose the amplification level which best suits their needs. Participants in the wait-list control group will continue the current practice (i.e. using conventional hearing aids or no hearing aids) from week 1 to week 8, and will use the smart hearing aids from week 8 to week 14. Caregivers will facilitate the participants to use the smart hearing aids.

Wait-list control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• With hearing impairment per the verbal or written medical recommendation by doctor, nurse, physiotherapist, occupational therapist or speech therapist, or currently using hearing aids other than the smart hearing aids in the current study, and
• Able to understand Chinese
• Responsible for helping the participants to use the smart hearing aids, and
• Able to understand Chinese

You may not qualify if:

• Unable to use the hearing aids independently, and
• Unable to use the hearing aids with caregivers' assistance, or
• Ménière's disease, or
• Deafness (i.e. cannot hear speech, even when the speaker is talking loudly next to the better hearing ear)
• Nil

Sponsors & Collaborators

• The University of Hong Kong: lead
• Haven of Hope Hospital: collaborator
• The Social Innovation and Entrepreneurship Development Fund, Hong Kong: collaborator
• Hong Kong Young Women's Christian Association: collaborator

Study Sites (3)

Haven of Hope Day Care Centre for the Elderly

Hong Kong, 00, Hong Kong

Location

Haven of Hope District Elderly Community Service

Hong Kong, 00, Hong Kong

Location

Hong Kong Young Women's Christian Association Wan Wah Care and Attention Home for the Elderly

Hong Kong, 00, Hong Kong

Location

Related Publications (8)

• Cox RM, Alexander GC. Measuring Satisfaction with Amplification in Daily Life: the SADL scale. Ear Hear. 1999 Aug;20(4):306-20. doi: 10.1097/00003446-199908000-00004.

  PMID: 10466567 BACKGROUND

• Kam AC. Hearing-aid outcomes in Chinese adults: clinical application and psychometric properties of the Chinese version of the Satisfaction with Amplification in Daily Life questionnaire. Int J Audiol. 2012 Jun;51(6):450-5. doi: 10.3109/14992027.2012.670732. Epub 2012 Apr 26.

  PMID: 22537034 BACKGROUND

• Liu T, Lu S, Leung DKY, Sze LCY, Kwok WW, Tang JYM, Luo H, Lum TYS, Wong GHY. Adapting the UCLA 3-item loneliness scale for community-based depressive symptoms screening interview among older Chinese: a cross-sectional study. BMJ Open. 2020 Dec 10;10(12):e041921. doi: 10.1136/bmjopen-2020-041921.

  PMID: 33303463 BACKGROUND

• Nieman CL, Betz J, Garcia Morales EE, Suen JJ, Trumbo J, Marrone N, Han HR, Szanton SL, Lin FR. Effect of a Community Health Worker-Delivered Personal Sound Amplification Device on Self-Perceived Communication Function in Older Adults With Hearing Loss: A Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2324-2333. doi: 10.1001/jama.2022.21820.

  PMID: 36538311 BACKGROUND

• Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant. 2010 May;25(5):1388-93. doi: 10.1093/ndt/gfp732. Epub 2010 Jan 12.

  PMID: 20067907 BACKGROUND

• Piau A, Campo E, Rumeau P, Vellas B, Nourhashemi F. Aging society and gerontechnology: a solution for an independent living? J Nutr Health Aging. 2014 Jan;18(1):97-112. doi: 10.1007/s12603-013-0356-5.

  PMID: 24402399 BACKGROUND

• Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.

  PMID: 8576833 BACKGROUND

• Veiga LR, Merlo AR, Mengue SS. Satisfaction level with hearing aid in the daily life of Army Healthcare System users. Braz J Otorhinolaryngol. 2005 Jan-Feb;71(1):67-73. doi: 10.1016/s1808-8694(15)31287-8. Epub 2006 Jan 2.

  PMID: 16446894 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yee Tak Cheung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor(s) of the follow-up outcomes and the research analysts will not be involved in the recruitment and intervention delivery and will be blinded to the group allocation (single blindness).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: Participants will be individually randomized to experimental group to use the smart hearing aids from week 1 to week 6, or wait-list control group to follow existing practice (i.e. using no hearing aids or using hearing aids other than the smart hearing aids) from week 1 to week 6 and use the smart hearing aids from week 8 to week 14. A list of random numbers will be generated to create a list of random group allocation (either experimental or wait-list control; allocation ratio 1:1), using the rand function of Excel. The research staff will perform the randomization procedure, by assigning consenting participants who meet all eligibility criteria to the two groups using the list.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 17, 2023
• Study Start: March 7, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for 10 years.

Locations

HK (3)