Randomised Controlled Trial of a Self-Affirmation Theory-Based Intervention to Promote Hearing Aid Use
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Hearing aid usage data from participants hearing aids
研究概览
简要总结
Hearing aids are the number one treatment for hearing loss and it is estimated that out of the 2 million of UK individuals who are supplied with hearing aids 1.4 million will use their hearing aids to varying degrees and the other 0.6 million will stop using their hearing aids altogether.
The proposed research is looking to improve hearing aid usage by using a self-affirmation intervention which lowers the threat of participants' ageing anxiety. The target of lowering participants' ageing anxiety to improve hearing aid use is because there is a stigma of hearing aids making people seem old and this stigma can make individuals resistant to wearing their hearing aids as they do not want to be seen in this light.
The current proposed research is an extension of a pilot study that was conducted in 2016 which found that a self-affirmation intervention may be useful in improving individuals' hearing aid usage. They randomly allocated 50 first-time hearing aid users either to a group that undertook a self-affirming exercise (e.g., "If I feel threatened or anxious, then I will think about the things I value about myself") or to a no-intervention control group. Consistent with the idea that self-affirmation helps people deal with threat, first-time hearing aid users reported significantly lower anxieties about ageing after self-affirming. Moreover, according to the data usage downloaded from their hearing aids (data-logging), the self-affirming group were found to have worn their hearing aids an average of two hours per day longer than the control group. Due to the limited number of participants, the effects of the intervention were not statistically significant. Nevertheless, the low cost and high potential public health "reach" alongside the effect size of d = 0.43 indicates that the intervention shows promise.
The main aim of this research is to re-test the self-affirmation intervention from the previous pilot study with a sufficiently large enough sample to answer the following "Does a self-affirmation intervention improve participant's hearing aid usage when compared to participants in the control group?
详细描述
Participants will be recruited through two NHS audiology clinics where they will be invited to participant in this study via an invitation letter either enclosed within their appointment letter or given to them at their audiology appointment. The information used to identify potential participants is that of their diagnoses (must be using or being supplied with hearing aids) . The audiology clinic staff will be identifying potential clients therefore it is believed that there is unlikely to be a breach of confidentiality. All participants will be sent a £10 shop-for-all voucher for participating in the second stage of the study (10-week post appointment) this will be sent to participants home after 6 months and this will include an invitation to a follow up questionnaire.
All prospective participants will be required to give written consent before being assigned to the study and those unable to do this will not be included. After consent is given participants will be allocated to either the intervention group or the control group. Procedure of the proposed study is as follows:
- Each participant will be randomly assigned to either the control group or the intervention group. Blinding of both the participant and the researcher with regards to which group the participant has been assigned to will be achieved by all questionnaires being placed in opaque envelopes which will have a number printed on the front of the envelope. The numbers from the envelope will be placed in a computerised list generator and an order list of how they are to be administered will be produced. Alternatively participants can go online and the platform will randomly assign them to either the intervention or the control questionnaire.
- Participants in both groups fill in a questionnaire which contain the following Scales: The Anxiety toward Ageing Scale (AAS), The Attitudes Toward Loss of Hearing Questionnaire (ATLH) and The Glasgow Benefit Hearing Aid Scale (GBHA) as well as a self-report question on their daily hearing aid use. The intervention group also undertake a self-affirmation exercise which is placed at the end of the questionnaire. This is expected to take 20-30 minutes.
- Participants return 10 weeks later (post) and have their hearing aid usage downloaded (hours per day the aids were worn) from their hearing aids by an audiologist before subsequently filling in another questionnaire which again contains the AAS, ATLH, GBHA and a self- report question on their daily hearing aid use. This is expected to take 30-40 minutes.
3A: If it is not possible for the participant to come back for a follow up appointment the second questionnaire will be sent out postal to the participants address or an email with a hyperlink to the follow up questionnaire online will be sent to participants who previously completed the first questionnaire online.
4: Six months later participants are contacted via email ( hyperlink) or post to fill in an optional questionnaire containing the AAS, ATLH, GBHA and a self-report question on their daily hearing aid use which they send back to the researcher. This should take 20-30 minutes. If participants receive the follow up questionnaire through the post the shopping voucher will also be enclosed. Online participants will also receive their shopping voucher through the post.
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
- Double (Participant, Investigator)
盲法说明
All postal questionnaires will be placed in opaque envelope and each envelope will be given a unique number, these unique numbers will be fed into a computerized list generator (www.random.org). The generated list will be used to put the questionnaires in batches for the audiologist to give to thier participants. The online version will automatically randomly assign participants to either the intervention or control.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18+ receiving hearing aids for the 1st time already have hearing aids fitted able to provide written consent and can complete the simple questionnaire
排除标准
- •Anyone younger than 18 anyone who does not wear a hearing aid anyone lacking in capacity to provide informed written consent.
研究组 & 干预措施
Intervention
Given the associated questionnaire which has the embedded self-affirmation exercise.
干预措施: Self-Affirmation Exercise (Behavioral)
Control
Given the associated questionnaire without the embedded self-affirmation exercise.
干预措施: Control (Behavioral)
结局指标
主要结局
Hearing aid usage data from participants hearing aids
时间窗: At the 10 weeks after baseline is taken
The daily use of participants hearing aid use is pulled from their hearing aids data logging
次要结局
- Participants self-reported measure of hearing aid use.(Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.)
- Participants Anxiety toward Aging(Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.)
- Participants perceived benefit / satisfaction participants have for their hearing aids(Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.)
- Participants hearing loss/aid stigma.(Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.)
研究者
Kerry Ware
Principal Investigator
University of Manchester
