ENACT Program on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life

NCT06955494 | Recruiting

• 1 other identifier: ENACT-Pilot
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Although previous studies indicated that tackling hearing loss may have a secondary benefit in improving cognitive function and delaying the onset of dementia, a more integrated care approach to optimize both hearing and cognitive function may be needed for individuals who already developed cognitive decline. To address the dual care needs for PwMCI and hearing impairment, it may be possible to integrate auditory training into cognitive training, as both of them are activity-based and focus on increasing the attention and working memory of an individual to engage in the auditory communication process. Moreover, auditory instruction is one of the core mediums in delivering cognitive training activities. It is highly possible to integrate the auditory training curricular to the corresponding administration process. To tackle the enhanced support need of individuals with dual functional impairment to engage in an integrated training protocol, strategies including a goal-oriented approach and peer support can be integrated to optimize the empowerment network. Including family members in the training is also important, as the auditory-communication process in everyday life would take place in the social interactional context. This is a pilot mixed-method pilot study comprising a randomized controlled trial and a post-trail qualitative interview. A total of 62 participants will be recruited from two community centers. The inclusion criteria include mild cognitive impairment according to Petersen's criteria; with at least one-side hearing impairment as defined by a score of 2- or 3-digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test); has a smartphone to access the online training materials; not received formal cognitive and auditory training in the past 6 months. After the baseline outcome evaluation, they will be randomized to receive the 12-week ENACT program or the usual care control. The nurse-led ENACT program comprises three phases, including i) the goal-oriented health counselling phase, ii) the peer-assisted group-based auditory-cognitive training phase, and iii) the family-engaged active-communication training phase. The outcome evaluation on hearing function, perceived benefit of auditory training, cognitive function, and HRQoL will be assessed at baseline, in the 12th and 18th weeks. Qualitative interviews will be conducted

Conditions

Hearing Loss; Cognitive Impairment, Mild

Keywords

cognitive impairment; hearing loss

Outcome Measures

Primary Outcomes (9)

• Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)

  Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.

  Baseline (T0)

• Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)

  Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.

  12th week (T1) after baseline

• Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)

  Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.

  18th week (T2) after baseline

• The digit span-forward and backward test

  Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function

  Baseline (T0)

• The digit span-forward and backward test

  Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function

  12th week (T1) after baseline

• The digit span-forward and backward test

  Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function

  18th week (T2) after baseline

• Trail-Making Test Part A and B

  Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function

  Baseline (T0)

• Trail-Making Test Part A and B

  Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function

  12th week (T1) after baseline

• Trail-Making Test Part A and B

  Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function

  18th week (T2) after baseline

Secondary Outcomes (9)

• Glasgow Hearing Aid Benefit Profile

  Baseline (T0)

• Glasgow Hearing Aid Benefit Profile

  12th week (T1) after baseline

• Glasgow Hearing Aid Benefit Profile

  18th week (T2) after baseline

• Revised Hearing Handicap Inventory for the Elderly

  Baseline (T0)

• Revised Hearing Handicap Inventory for the Elderly

  12th week (T1) after baseline

Study Arms (2)

ENACT program

EXPERIMENTAL

The ENACT Program is an overall 12-week training and comprises of three phases as follows: 1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment. 2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. 3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly.

Other: Empowerment Network for Auditory-Cognitive Training (ENACT) Program

Usual care

PLACEBO COMPARATOR

Usual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection.

Other: Usual Care

Interventions

Usual Care OTHER

Usual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection.

Usual care

Empowerment Network for Auditory-Cognitive Training (ENACT) Program OTHER

The ENACT Program is an overall 12-week training and comprises of three phases as follows: 1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment. 2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. 3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly.

ENACT program

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Persons living with mild cognitive impairment (PLwMCI) who have hearing impairment
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild cognitive impairment accordingly to the Petersen's criteria
• With at least one-side hearing impairment as defined by a score of 2- or 3- digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test)
• Has a smartphone to access the online training materials
• Not received formal cognitive and auditory training in the past 6 months.
• Available of primary caregiver in the family
• give consent to participate

You may not qualify if:

• moderate and severe cognitive impairment
• Other sensory impairment

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (14)

• Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.

  PMID: 15324362 BACKGROUND

• Laplante-Levesque A, Hickson L, Worrall L. Rehabilitation of older adults with hearing impairment: a critical review. J Aging Health. 2010 Mar;22(2):143-53. doi: 10.1177/0898264309352731. Epub 2010 Jan 7.

  PMID: 20056812 BACKGROUND

• Hallberg LR, Hallberg U, Kramer SE. Self-reported hearing difficulties, communication strategies and psychological general well-being (quality of life) in patients with acquired hearing impairment. Disabil Rehabil. 2008;30(3):203-12. doi: 10.1080/09638280701228073.

  PMID: 17852289 BACKGROUND

• Sprinzl GM, Riechelmann H. Current trends in treating hearing loss in elderly people: a review of the technology and treatment options - a mini-review. Gerontology. 2010;56(3):351-8. doi: 10.1159/000275062. Epub 2010 Jan 12.

  PMID: 20090297 BACKGROUND

• Jorgensen LE, Messersmith JJ. Impact of Aging and Cognition on Hearing Assistive Technology Use. Semin Hear. 2015 Aug;36(3):162-74. doi: 10.1055/s-0035-1555119.

  PMID: 27516716 BACKGROUND

• Gallagher NE, Woodside JV. Factors Affecting Hearing Aid Adoption and Use: A Qualitative Study. J Am Acad Audiol. 2018 Apr;29(4):300-312. doi: 10.3766/jaaa.16148.

  PMID: 29664724 BACKGROUND

• Zheng H, Wong LLN, Hickson L. Barriers to hearing aid adoption among older adults in mainland China. Int J Audiol. 2023 Sep;62(9):814-825. doi: 10.1080/14992027.2022.2105263. Epub 2022 Aug 23.

  PMID: 35997572 BACKGROUND

• Bucholc M, Bauermeister S, Kaur D, McClean PL, Todd S. The impact of hearing impairment and hearing aid use on progression to mild cognitive impairment in cognitively healthy adults: An observational cohort study. Alzheimers Dement (N Y). 2022 Feb 22;8(1):e12248. doi: 10.1002/trc2.12248. eCollection 2022.

  PMID: 35229022 BACKGROUND

• Dawes P, Wolski L, Himmelsbach I, Regan J, Leroi I. Interventions for hearing and vision impairment to improve outcomes for people with dementia: a scoping review. Int Psychogeriatr. 2019 Feb;31(2):203-221. doi: 10.1017/S1041610218000728. Epub 2018 Sep 24.

  PMID: 30244688 BACKGROUND

• Chen L, Zhou R. Does self-reported hearing difficulty decrease older adults' cognitive and physical functioning? The mediating role of social isolation. Maturitas. 2020 Nov;141:53-58. doi: 10.1016/j.maturitas.2020.06.011. Epub 2020 Jun 20.

  PMID: 33036703 BACKGROUND

• Mitchell AJ, Shiri-Feshki M. Rate of progression of mild cognitive impairment to dementia--meta-analysis of 41 robust inception cohort studies. Acta Psychiatr Scand. 2009 Apr;119(4):252-65. doi: 10.1111/j.1600-0447.2008.01326.x. Epub 2008 Feb 18.

  PMID: 19236314 BACKGROUND

• Lawrence BJ, Jayakody DMP, Bennett RJ, Eikelboom RH, Gasson N, Friedland PL. Hearing Loss and Depression in Older Adults: A Systematic Review and Meta-analysis. Gerontologist. 2020 Apr 2;60(3):e137-e154. doi: 10.1093/geront/gnz009.

  PMID: 30835787 BACKGROUND

• 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 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661.

  PMID: 14570962 BACKGROUND

• Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.

  PMID: 22169081 RESULT

MeSH Terms

Conditions

Hearing Loss; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• SAU FUNG DORIS YU, PhD

  HKU School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SAU FUNG DORIS YU, PhD

CONTACT

852-39176319; dyu1@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pilot randomized controlled trial will be conducted in two elderly community centers of a non-government organization in Hong Kong. Participants will be randomized into intervention group and control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The ENACT Program is an overall 12-week training and comprises of three phases as follows: 1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment. 2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. 3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 2, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)