- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01837550
Educational Program for Hearing Aid Users With Internet Support
A Randomized, Controlled Trial Evaluating the Short- and Long-term Effects of an Internet-based Aural Rehabilitation Program for Hearing Aid Users Implemented in a General Clinical Practice
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Aural rehabilitation aims to improve communication for people with hearing impairment. Education is widely regarded as an integral part of rehabilitation, but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials. Internet as a complement to aural rehabilitation has been tested in different studies with promising results. Though, until now not applied clinically as a part of an aural rehabilitation, focusing on hearing aid users with persistent self- reported hearing problems.
The purpose of this study was to evaluate the effect of an internet-based aural rehabilitation for hearing aid users from a clinical population.
Participants were randomly assigned to an intervention or control group. The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum. The control group only had access to reading material.
The Hearing Handicap Inventory for the Elderly (HHIE), the Hospital Anxiety and Depression Scale (HADS) and the Communication Strategies Scale (CSS) were used to measure the outcomes of this study; and were recorded before and directly after the intervention as well as 6 months post-intervention.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Vastra Gotalandsregion
-
Boras, Vastra Gotalandsregion, Sverige, 501 82
- Hearing Clinic, Hearing Organization
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- the hearing aid users to be between 20 and 80 yr of age,
- the hearing aid users to have conductive or sensorineural hearing loss of mild to moderate degree (20-60 decibel Hearing Level pure-tone average measured across 500, 1000, and 2000 Hertz),
- the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
- the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of >20 points (indicative of some residual self-reported hearing problems),
- the hearing aid users to provide informed consent to participate
Exclusion Criteria:
- the hearing aid users who are not fulfilling the conditions to participate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Control group
no professional support
|
The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum.
|
|
Eksperimentell: Intervention group
Professional support via Internet
|
The control group only had access to reading material.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Hearing Handicap Inventory for the Elderly (HHIE)
Tidsramme: 5 weeks, 6 months
|
The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss.
Higher score reflects a higher self-reported hearing problem.
Minimum score for the total scale (reported) is 0 and maximum score is 100 points.
|
5 weeks, 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
Tidsramme: pre-measurement
|
The IOI-HA measures hearing aid outcomes.
The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life.
Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.
|
pre-measurement
|
|
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 5 weeks, 6 months
|
The HADS contains 14 items.
Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression.
Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.
|
5 weeks, 6 months
|
|
Communication Strategies Scale (CSS)
Tidsramme: 5 weeks, 6 months
|
CSS is designed to analyze participants' behavior in various communication situations.
Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs.
Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.
|
5 weeks, 6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Gerhard Andersson, Professor, Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.
- Hovedetterforsker: Thomas Lunner, Professor, Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HörNet VGR
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .