Hearing Loss, Functional Clinical Trial
Official title:
Randomised Controlled Trial of a Self-Affirmation Theory-Based Intervention to Promote Hearing Aid Use
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?
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:
1. 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.
2. 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.
3. 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.
5: A debrief form will be sent out via e-mail or post by the principal researcher 3 weeks
after the follow up questionnaire was returned or alternatively if they decide to not to
complete the follow up questionnaire the debrief will be sent 4 weeks after the initial
questionnaire request was sent.
A G-power analysis was conducted to detect a small-moderate effect size (Cohen's D of 0.35)
with 80% power at the 5% significance level which indicated that a sample of 260 participants
(130 per group) would be required. This study will attempt to recruit 400 based on a similar
pilot study having a 34% attrition rate. The data collection phase will continue until 260
participants have completed the 10 week follow up.
The study design is a mixed Design: Between-participants factor is condition (control vs
intervention). Within-participants factor is time (pre-intervention vs post intervention
(10-week) vs exit (6 month after post ). We will use a series of 2 (Intervention, control) x
3 ( pre-intervention, post intervention and exit) repeated ANOVA to assess to assess the
outcome measures. If a small-moderate effect size (Cohen's d = 0.35) is found on any of the
principle and secondary measures, then the Hayes PROCESS macro will be used to examine the
possible mediating effects of the intervention on participants' hearing aid usage. If data is
missing at the 10-week follow up the participant concerned will be excluded from the analysis
at this point. The present study also has a longitudinal element and attrition at 6 months is
expected. Any missing data will be addressed by using the "last observation carried forward
technique".
All data such as contact details and ethnicity will be pseudonymised and kept in a separate,
password protected file, in a restricted access folder on a secure University server. All
paper copies of contact details and questionnaire data will be secured in Manchester
University in a locked filing cabinet. Only the study team and regulatory monitoring and
auditing authorities from the University of Manchester will have access to this data.
All the questionnaire data will be anonymised and kept in a separate, password protected
file, in a restricted access folder on a secure University server. Only the study team and
regulatory monitoring and auditing authorities from the University of Manchester will have
access to this data.
The physical personal data copies will be kept until completion of the study then will be
destroyed in accordance with University of Manchester regulations. All consent forms and
questionnaire data are deemed as essential and this will be kept for 5 years to comply with
University of Manchester regulations.
The current study will go through ethics approval with the National Health Service, Health
Research Authority in the UK before it will be allowed to proceed. The study has already been
through a preliminary ethics review at the University of Manchester.
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