[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414037":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":50,"centralContacts":55,"locations":60,"responsibleParty":78,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":32,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":32,"enrollmentInfo":93,"targetDuration":32,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":32,"overallStatus":63,"whyStopped":32,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Alabama, Tuscaloosa","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Audiology Best Practices plus Aural Rehabilitation (ABP+AR)","EXPERIMENTAL","This experimental group will receive a hearing evaluation, an over-the-counter hearing aid fitting and orientation, and four-weeks of an aural rehabilitation program conducted by specially-trained community health workers. Additionally, these adults will complete pre- and post-questionnaires and speech perception testing.",[13,14,15],"Behavioral: Hearing Evaluation","Device: Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation","Behavioral: Four Weeks of Aural Rehabilitation",{"label":17,"type":18,"description":19,"interventionNames":20},"Audiology Best Practices (ABP)","ACTIVE_COMPARATOR","This comparison group of adults with hearing loss will receive a hearing evaluation and over-the-counter hearing aid fitting and orientation. The aural rehabilitation program will not be provided initially. These participants will complete pre- and post-questionnaires and speech perception testing.",[13,15],{"label":22,"type":18,"description":23,"interventionNames":24},"Over-the-Counter Only (OTC-Only)","This comparison group of adults with hearing loss will receive a hearing evaluation. They will be provided with over-the-counter hearing aids but the audiologist will not assist with fitting the aids or providing an orientation. This arm mimics what would happen when a consumer privately purchases over-the-counter hearing aids. They will complete pre- and post-questionnaires and speech perception testing.",[13,25],"Device: Provision of Over-the-Counter Hearing Aids",[27,33,40,44],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BEHAVIORAL","Hearing Evaluation","Behavioral thresholds for pure tones will be conducted along with speech perception measures.",[17,9,22],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DEVICE","Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation","Study participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices.",[9],[39],"Over-the-Counter Hearing Aid Fitting and Orientation",{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":32},"Four Weeks of Aural Rehabilitation","Participants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss.",[17,9],{"type":34,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Provision of Over-the-Counter Hearing Aids","Study participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist.",[22],[49],"Provision of Over-the Counter Hearing Aids",[51],{"name":52,"affiliation":53,"role":54},"Marcia J Hay-McCutcheon, PhD","The University of Alabama, Tuscaloosa","PRINCIPAL_INVESTIGATOR",[56],{"name":52,"role":57,"phone":58,"phoneExt":32,"email":59},"CONTACT","205-348-4572","mhaymccu@ua.edu",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"The University of Alabama","RECRUITING","Tuscaloosa","Alabama","35487","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-87.56917,33.20984,{"lat":73,"lon":72},[76],{"name":77,"role":57,"phone":58,"phoneExt":32,"email":59},"Marcia J Hay-McCutchoen, PhD",{"type":79,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[81],{"name":82,"class":6},"University of Alabama at Birmingham","100414037","improving-access-and-affordability-of-adult-hearing-healthcare-100414037",false,"NCT04671381","Improving Access and Affordability of Adult Hearing Healthcare","Improving Access and Affordability of Adult Hearing Healthcare: Effectiveness of Community-based Interventions in West Central and South Alabama","Inclusion Criteria:\n\n* Mild-to-moderate hearing loss\n* Live in West Central or South Alabama\n* 40 years of age or older\n\nExclusion Criteria:\n\n• Medical conditions resulting in severe cognitive impairment (e.g., stroke, head injury, senile dementia or Alzheimer's disease)",true,"ALL","40 Years",{"count":94,"type":95},210,"ESTIMATED","INTERVENTIONAL",[98],"NA","This project will address quality of care issues associated with hearing loss in adults who have mild-to-moderate hearing loss and who have no access to hearing healthcare. Through the use of three different interventions involving over-the-counter hearing aids, it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.",[101],"Hearing Loss","2024-10-28",{"date":104,"type":105},"2024-10-30","ACTUAL",{"date":107,"type":105},"2021-01-01",{"date":109,"type":95},"2025-12",{"name":5,"class":6},1]