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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe University of Hong Kong

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

moderate and severe cognitive impairment

Other sensory impairment

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: ENACT programExperimental treatment 1 intervention
Group B: Usual carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (T0)
2

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.

Time frame
12th week (T1) after baseline
3

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.

Time frame
18th week (T2) after baseline
4

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

Time frame
Baseline (T0)

Secondary outcomes

1

Glasgow Hearing Aid Benefit Profile

Assess the self-perceived benefit of auditory training

Time frame
Baseline (T0)
2

Glasgow Hearing Aid Benefit Profile

Assess the self-perceived benefit of auditory training

Time frame
12th week (T1) after baseline
3

Glasgow Hearing Aid Benefit Profile

Assess the self-perceived benefit of auditory training

Time frame
18th week (T2) after baseline
4

Revised Hearing Handicap Inventory for the Elderly

Assess the perceived hearing loss, higher score means greater handicapping effect of a hearing impairment

Time frame
Baseline (T0)

Other outcomes

Sponsors and contacts

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