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

NCT ID: NCT06955494

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2026-12-31

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

Detailed Description

Research evidence on tackling the dual cognitive and hearing impairment is very limited. Although previous studies indicated that tackling hearing loss may have a secondary benefit on improving cognitive function and delay 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. In fact, cognitive training is a standard evidence-based care to managing MCI. It is timely to explore how the management of hearing loss can be integrated to cognitive training to tackle the dual impairment. To address the dual care needs for PwMCI and hearing impairment, it may be possible to integrate auditory training to cognitive training, as both of them are activity-based and focusing 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 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.

The target population is the persons living with mild cognitive impairment (PLwMCI) who have hearing impairment. MCI is defined by a score of 19-26 out of the 30 on the Montreal Cognitive Assessment (education adjusted), the presence of subjective memory complaint and preserved daily activity function. [30] Hearing impairment is identified by the integrated Digit-In-Noise (DIN) test developed by the Co-I (L Wong) with the results of 2- or 3-digit results greater than the norm value to indicate hearing loss. Other inclusion criteria include: i) available of primary caregiver in the family, ii) have smart phone to receive online training materials, iii) not receive formal cognitive or auditory training in the past 6 months, iv) no other sensory impairment, and v) consent to participate.

The 12-week Empowerment Network on Auditory-Cognitive Training (ENACT) Program aims to offer combined auditory and cognitive training to the PLwMCI with hearing loss. A person-centered approach is used to not only engage the PLwMCI in combined auditory-cognitive training, but also to empower them and their significant others to maintain better communication, social interaction and social engagement in everyday life. Empowerment network refers to the use of collaborative and partnership approach between the nurse, family member and peer health coach to optimize and sustain the training effects of ENACT program. The ENACT Program comprises of three phases as follows:

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, particularly on how it affects their daily living, social engagement, coping and adaptation. Education on how such functional decline set up a vicious cycle of further impairment will be given to motivate self-directed goal setting. An agreeable action plan with consideration of the clients' preference and resource will be developed. On the followed week, the nurse will conduct a telephone visit to follow up the action plan implementation and give additional support if needed.

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. The content for the six sessions is developed according to the hierarchy of auditory skills proposed by Erher which comprises four level of increasing difficulty including sound awareness, sound discrimination, sound identification and sound comprehension. Activities proposed by the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) on working memory training, attention bias motivation, and cognitive interpretive training are integrated in planning the auditory training activities to achieve the dual benefit.[33] To better secure the participants' confidence and motivation in learning, the training will be commenced with low difficulty level with lower level auditory training, and progressively to incorporate more cognitive training activities and higher level auditory training. A total of 2-3 trained peer health coach will join the group session to facilitate the practice. Home exercise in format of audio-scripts and online response grid are developed, so that the health coach can better engage the participants via their preferred social platform such as WhatsApp's or WeChat for two times before the next group session. Each qualified health coach has received 12- hour training which covers effective communication with persons with auditory-cognitive impairment, instructions to administer auditory and cognitive training activities, and motivational strategies for older adults.

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. The content is developed according to Active Communication Education (ACE Program) which developed for adults with hearing loss. This phase will comprise 2 bi-weekly training sessions for the PLwMCI and 2 online training sessions with the involvement of the primary family caregivers. The online session is needed as effective communication take places in interactional and interpersonal context. The importance and strategies for the family to engage the PLwMCI in everyday decision-making and activity will also be highlighted.

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.

This is a pilot mixed method study, comprising a randomized controlled trial and a post-trail qualitative interview. A total of 62 participants will be recruited from two community center. The inclusion criteria include 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. 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) goal-oriented health counseling 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, the cognitive function and HRQoL will be assessed at baseline, 12th and 18th week. Qualitative interview with the PLwMCI, their family members and the peer health coach will be conducted to solicit their experience in the process.

The nurse will assess the baseline outcomes of the participants with the following validated measures before randomization. Another RA who has no information about the group assignment will conduct the post-test measure at the 12th and 18th week after the commencement of the intervention.

1. A battery of cognitive assessment will be used to evaluate various domains of cognition of the PLwMCI, including the Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) for global cognition, the digit span-forward and backward test for attention and working memory, and Trail-Making Test Part A and B for complex attention, executive function and task switching. Multiple assessments are essential for detecting subtle cognitive changes.

2. The Glasgow Hearing Aid Benefit Profile will assess the self-perceived benefit of auditory training.

3. The Revised Hearing Handicap Inventory for the Elderly [37] to assess the perceived hearing loss.

4. The Short-From 12 Survey to measure the overall HRQoL as well as the physical and mental health.

Upon the completion of the ENACT Program, interviews will be conducted to the participants and their family caregivers in a dyadic format. Focus group interview will be conducted to health coach. The interviews will be audiotaped with the consent of the participants. Interview guides with open-ended questions are used to guide the interviews.

Data will be analyzed on an intention-to-treat basis. Skewed variables will be transformed before subjected to analyses. Baseline characteristics between the two arms of participants will be compared using t test, chi-square test or Fisher's exact test, as appropriate. Generalized Estimating Equation will be used to compare the differential changes on the health outcomes of the PLwMCI and family caregivers across the baseline, 12th week (T2) and 18th Week (T3) between the two study arms, with adjustment for a set of priori control variables including age, sex, educational level and other comorbidity burden. The findings will provide important insights on the feasibility, clients' perception and preliminary effect of an innovative care approach to tackle dual functional loss in PLwMCI with hearing loss.

Conditions

Hearing Loss; Cognitive Impairment, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ENACT program

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.

Group Type: EXPERIMENTAL

Empowerment Network for Auditory-Cognitive Training (ENACT) Program

Intervention Type: 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.

Usual care

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.

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: 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.

Interventions

Empowerment Network for Auditory-Cognitive Training (ENACT) Program

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.

Intervention Type: OTHER

Usual Care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• moderate and severe cognitive impairment
• Other sensory impairment

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Yu, Doris Sau Fung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SAU FUNG DORIS YU, PhD

Role: PRINCIPAL_INVESTIGATOR

HKU School of Nursing

Locations

The University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

SAU FUNG DORIS YU, PhD

Role: CONTACT

dyu1@hku.hk

852-39176319

Facility Contacts

Doris Yu Sau Fung, PhD

Role: primary

dyu1@hku.hk

+852 3917 6319

References

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Reference Type: RESULT

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ENACT-Pilot

Identifier Type: -

Identifier Source: org_study_id