Effectiveness of a Smart Hearing Aid on Improving Psychosocial Well-being in Elderly: A Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- 6-week change in loneliness after using the smart hearing aids for 6 weeks
研究概览
简要总结
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:
- Can the use of the smart hearing aids reduce loneliness at the end of intervention?
- Can the use of the smart hearing aids improve quality of life at the end of intervention?
Secondary study questions: 3. Can the use of the smart hearing aids improve the communication quality between caregivers and participants at the end of intervention? 4. How is the satisfaction of the participants with the smart hearing aids? 5. What are the factors leading to the use and non-use of the smart hearing aids? 6. What is the usage time of the smart hearing aids?
Auxiliary study questions: 7. How is the caregiver burden when facilitating the participants to use the smart hearing aids? 8. What are the perceived benefits and acceptability of the smart hearing aids?
详细描述
Study design
This is a randomised waitlist controlled trial of comparing the outcome indicators between elders using the smart hearing aids for 6 weeks and elders not using the aids. Elders with hearing impairment from District Elderly Community Service, Haven of Hope Christian Service (HOH DECS) and Day Care Centre for the Elderly, Haven of Hope Christian Service (HOH DE) 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. We will also explore the perceived benefits and acceptability of the smart hearing aids of the participants and caregivers.
This protocol complies with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki.
Subjects
Elders 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 from HOH DECS and HOH DE will be recruited for the main analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for participants:
- •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
- •Inclusion criteria for caregivers:
- •Responsible for helping the participants to use the smart hearing aids, and
- •Able to understand Chinese
排除标准
- •Exclusion criteria for participants:
- •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)
- •Exclusion criteria for caregivers:
结局指标
主要结局
6-week change in loneliness after using the smart hearing aids for 6 weeks
时间窗: Baseline, the 6th week and the 14th week (waitlist control group only)
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.
6-week change in quality of life after using the smart hearing aids for 6 weeks
时间窗: Baseline, the 6th week and the 14th week (waitlist control group only)
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.
次要结局
- 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)
- 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)
- Qualitative Measure: Perceived benefits and acceptability of the smart hearing aids of participants(Within 2 weeks after the participants using the smart hearing aids for 6 weeks)
- Qualitative Measure: Perceived benefits and acceptability of the smart hearing aids of caregivers.(Within 2 weeks after the participants using the smart hearing aids for 6 weeks)
研究者
Dr. Derek Yee-Tak Cheung
Principal Investigator, Assistant Professor
The University of Hong Kong