← Back to all trials
Not Yet Recruiting
NCT07866586
New Hearing Aid Users and Their Social Participation
Conditions: Hearing Loss, Hearing Aids, Social Participation
Sex: All
Ages: 50 Years – 90 Years
Healthy volunteers: No
Enrollment: 32
Sponsor: University of Nottingham
Summary
Does first-ever hearing aid fitting change social participation?
Using a mixed methods approach made up of audiological assessments (hearing test and examination of the ear canal and eardrum), questionnaires, semi-structured interview and surveys, the study aims to gain a comprehensive and in-depth understanding of the experiences (in the first 12-13 months) of initial hearing aid users in relation to their social participation.
PRIMARY OBJECTIVE The primary outcome measures will be to compare scores on the ecological momentary assessment (EMA) ratings of social engagement and experience for social participation situations over the course of a participant's 13-month involvement in the study.
Differences in an individual's social networks analysis (SNA) will be examined in this longitudinal study to see if there are changes in social structure over time. This will involve looking at the network size, number of connections related to activities someone does, how they feel about the social connections and the support they get from their social network.
Assessing longitudinal changes in:
* International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire - effectiveness of hearing aid(s).
* Revised Hearing Handicap Inventory (RHHI) - emotional and social impacts of hearing loss.
* Social Participation Restrictions Questionnaire (SPaRQ) - how hearing limits social life
* The Hearing-Related Lifestyle Questionnaire (HEARLI-Q) - the influence of hearing ability in everyday listening situations.
Qualitative outcome measures - investigating the semi-structured interview and open text box response answers over the longitudinal study to explore personal perspectives, motivations and responses to questions related to social participation difficulties and avoidance, using reflexive thematic analysis
Eligibility Criteria
Inclusion Criteria:
* Adults aged 50 - 90 years (inclusive).
* Ability to give informed consent.
* Presence of a hearing loss (with a 4-frequency average (0.5-4kHz) of hearing thresholds greater than 25 dB HL in their better hearing ear).
* Awaiting first ever fitting of hearing aid(s).
* Available for the study visits over 13 months (e.g. not expected to be moving out of the local area).
* Sufficient command of English to read, understand and complete questionnaires
Exclusion Criteria:
* Ear pathologies - acute or chronic middle ear diseases.
* Troublesome tinnitus.
* Fluctuating hearing loss.
Source: ClinicalTrials.gov (NCT07866586). StuddyBuddy aggregates publicly available trial information.