[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659463":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":35,"armGroups":31,"interventions":36,"overallOfficials":31,"centralContacts":40,"locations":31,"responsibleParty":46,"collaborators":48,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":31,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":31,"briefSummary":69,"conditions":70,"keywords":31,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":31},{"fullName":5,"class":6},"University of Nottingham","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Scores on EMA ratings","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. Ratings of engagement and experience are on a 5-point likert scale with '5' indicating the most positive engagement\u002Fexperience.","from enrolment to 12 months post first hearing aid fitting",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Assessing longitudinal changes in questionnaire scores - International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire","Looking at the effectiveness of hearing aid(s). A seven item questionnaire (with five ordinal response options for each item). Scoring ranges from a min-max of 7-35 respectively, with a higher total score indicating a better overall outcome and greater hearing aid satisfaction","From study enrolment to 12 months post hearing aid fitting",{"measure":19,"description":20,"timeFrame":17},"Assessing longitudinal changes in questionnaire scores - Revised Hearing Handicap Inventory (RHHI)","Examining the emotional and social impacts of hearing loss. 18 item questionnaire and responses are scored (yes = 4, sometimes = 2, and no = 0). Range of scoring is 0 -72 with higher scores showing a greater psychosocial impact ( or a worse outcome)",{"measure":22,"description":23,"timeFrame":17},"Assessing longitudinal changes in questionnaire scores - Social Participation Restrictions Questionnaire (SPaRQ)","A questionnaire looking at how hearing limits social life, with two subscales (nine items for social behaviours and ten items for social perceptions). Each item is rated on a scale from 0 (completely disagree) to 10 (completely agree). Higher scores indicate worse outcomes (greater restrictions in social participation caused by hearing loss) .",{"measure":25,"description":26,"timeFrame":17},"Assessing longitudinal changes in questionnaire scores - The Hearing-Related Lifestyle Questionnaire (HEARLI-Q)","This questionnaire examines the influence of hearing ability in everyday listening situations. Asking about:\n\n* frequency of occurrence (ranges from never (0) to daily (4)),\n* importance to hear well (not important (0) to extremely important (4)),\n* hearing difficulty (not difficult (0) to extremely difficult (4))\n* hearing aid satisfaction (not satisfied (1) to extremely satisfied (5))\n\nScored according to richness of lifestyle (relates to frequency of occurrence with higher score implying greater frequency), hearing demand (the occurrence and importance score combined ) - with higher scores suggesting more demand on hearing. Hearing difficulty and hearing aid satisfaction look at the mean across the listening situations. The higher score on hearing difficult suggests more challenge while a high score on hearing aid satisfaction suggests more positive\u002Fbeneficial use of hearing aids",{"measure":28,"description":29,"timeFrame":30},"Qualitative analysis of semi-structured interview and open text box responses","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.","from enrolment to 12 months post hearing aid fitting",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","PROSPECTIVE","Participants will be recruited from NHS Greater Glasgow and Clyde audiology departments and be people awaiting first fit of hearing aid(s)",[37],{"type":6,"name":38,"description":39,"armGroupLabels":31,"otherNames":31},"Observation","Longitudinal designed study over 13-months in first-ever adult hearing aid users, using a mixed methods approach with audiological assessments (hearing test and examination of the ear canal and eardrum), questionnaires, semi-structured interviews and smart-phone surveys.",[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Lindsey L Steele, MSc Audiology","CONTACT","+44 (0) 141 2429665","lindsey.steele@nottingham.ac.uk",{"type":47,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[49,51],{"name":50,"class":6},"NHS Greater Glasgow and Clyde",{"name":52,"class":53},"WSAUD A\u002FS","INDUSTRY","100659463","new-hearing-aid-users-and-their-social-participation-100659463",false,"NCT07866586","New Hearing Aid Users and Their Social Participation","Investigating the Impact of Hearing Aids on Social Participation in First-time Adult Hearing Aid Users: A 13-month Longitudinal Study","Inclusion Criteria:\n\n* Adults aged 50 - 90 years (inclusive).\n* Ability to give informed consent.\n* 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).\n* Awaiting first ever fitting of hearing aid(s).\n* Available for the study visits over 13 months (e.g. not expected to be moving out of the local area).\n* Sufficient command of English to read, understand and complete questionnaires\n\nExclusion Criteria:\n\n* Ear pathologies - acute or chronic middle ear diseases.\n* Troublesome tinnitus.\n* Fluctuating hearing loss.","ALL","50 Years","90 Years",{"count":65,"type":66},32,"ESTIMATED","13 Months","OBSERVATIONAL","Does first-ever hearing aid fitting change social participation?\n\nUsing 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.\n\nPRIMARY 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.\n\nDifferences 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.\n\nAssessing longitudinal changes in:\n\n* International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire - effectiveness of hearing aid(s).\n* Revised Hearing Handicap Inventory (RHHI) - emotional and social impacts of hearing loss.\n* Social Participation Restrictions Questionnaire (SPaRQ) - how hearing limits social life\n* The Hearing-Related Lifestyle Questionnaire (HEARLI-Q) - the influence of hearing ability in everyday listening situations.\n\nQualitative 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",[71,72,73],"Hearing Loss","Hearing Aids","Social Participation","NOT_YET_RECRUITING","2026-10-05",{"date":77,"type":78},"2026-10-08","ACTUAL",{"date":80,"type":66},"2026-10-01",{"date":82,"type":66},"2028-06-01",{"name":5,"class":6}]