A Self-Affirmation Intervention to Promote Hearing Aid Use
Randomised Controlled Trial of a Self-Affirmation Theory-Based Intervention to Promote Hearing Aid Use
2 other identifiers
interventional
400
0 countries
N/A
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedStudy Start
First participant enrolled
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2022
CompletedSeptember 16, 2020
May 1, 2020
1.2 years
May 4, 2020
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Hearing aid usage data from participants hearing aids
The daily use of participants hearing aid use is pulled from their hearing aids data logging
At the 10 weeks after baseline is taken
Secondary Outcomes (4)
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 hearing loss/aid stigma.
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.
Study Arms (2)
Intervention
EXPERIMENTALGiven the associated questionnaire which has the embedded self-affirmation exercise.
Control
ACTIVE COMPARATORGiven the associated questionnaire without the embedded self-affirmation exercise.
Interventions
The self affirming exercise is as follow: The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines provided, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you. If I feel threatened or anxious, then I will ………………………………….. Options are as follows: think about the things I value about myself, remember things that I have succeeded in, think about what I stand for or think about things that are important to me
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Anyone younger than 18 anyone who does not wear a hearing aid anyone lacking in capacity to provide informed written consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Armitage CJ, Lees D, Lewis K, Munro KJ. Preliminary support for a brief psychological intervention to improve first-time hearing aid use among adults. Br J Health Psychol. 2017 Nov;22(4):686-700. doi: 10.1111/bjhp.12244. Epub 2017 May 9.
PMID: 28485483BACKGROUNDOverall, J. E., Tonidandel, S., & Starbuck, R. R. (2009). Last-observation-carried-forward (LOCF) and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts. Social Science Research, 38(2), 492-503.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerry Ware
The University of Manchester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 11, 2020
Study Start
October 5, 2020
Primary Completion
December 20, 2021
Study Completion
September 26, 2022
Last Updated
September 16, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share