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Effects of an Online Hearing Support for First-time Hearing Aid Users

Sponsor
Region Skane (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06051968
Collaborator
Horselvarden Region Ostergotland (Other)
100
Enrollment
1
Location
2
Arms
38
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Online hearing support for first-time hearing aid users
  • Behavioral: Hearing rehabilitation according to common practice.
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of an Online Hearing Rehabilitation Support for First-time Hearing Aid Users: A Randomised Controlled Trial.
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Participants get hearing rehabilitation according to common practice and the online hearing support.

Behavioral: Online hearing support for first-time hearing aid users
Participants get hearing rehabilitation according to common practice and the online hearing support consists of five chapters that aim to give information, support, and advice to the new hearing aid users. The participants are assigned a new chapter between each visit at the clinic.
Other Names:
  • Stöd och Behandling för nya hörapparatanvändare
  • Internetbaserat stöd vid hörselrehabilitering

    		•
    Active Comparator: Control group

    Participants get hearing rehabilitation according to common practice.

    Behavioral: Hearing rehabilitation according to common practice.
    Participants get hearing rehabilitation according to common practice.

    Outcome Measures

    Primary Outcome Measures

    1. The Hearing Handicap Inventory for the Elderly (HHIE) [Baseline, directly post intervention and 6 months post intervention.]

      Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.

    Secondary Outcome Measures

    1. The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12) [Baseline, directly post intervention and 6 months post intervention.]

      Assessing experience of listening in complex sound environments. Minimum 0 points to 120 points. Higher score indicates less problems with hearing in the specified situations.

    2. Communication Strategies Scale (CSS) [Baseline, directly post intervention and 6 months post intervention.]

      Assessing changes in use of verbal, non-verbal and maladaptive communication strategies. Minimum 25 points to maximum 125 points. Higher score indicates a greater use of communication strategies.

    3. The International Outcome Inventory for Hearing Aids (IOI-HA) [Directly post intervention and 6 months post intervention.]

      Assessing changes in perceived effectiveness and satisfaction with hearing aids. Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.

    Other Outcome Measures

    1. Subjective impact of the intervention, reported by the users: Memory of the intervention [6 months post intervention]

      The participants are asked what they remember from their intervention.

    2. Subjective impact of the intervention, reported by the users: Seeking more or other information [6 months post intervention]

      The participants are asked if they searched for more or other information about hearing or hearing aids.

    3. Subjective impact of the intervention, reported by the users: Adverse effects [6 months post intervention]

      The participants are asked if they experienced any adverse effects of the intervention.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults > 20 years of age that are eligible for hearing aids

    • Access to a computer, tablet and/or smartphone with internet

    • Access to a Swedish BankID or equivalent

    Exclusion Criteria:
    • Inability to read and understand Swedish

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Audiologimottagningen Lund Lund Sweden

    Sponsors and Collaborators

    • Region Skane
    • Horselvarden Region Ostergotland

    Investigators

    • Principal Investigator: Marie Öberg, Horselvarden Region Ostergotland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Region Skane
    ClinicalTrials.gov Identifier:
    NCT06051968
    Other Study ID Numbers:
    • 2023-01633-02
    First Posted:
    Sep 25, 2023
    Last Update Posted:
    Sep 25, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hearing Loss
    Deafness
    Ear Diseases
    Hearing Disorders
    Otorhinolaryngologic Diseases
    Sensation Disorders

    Study Results

    No Results Posted as of Sep 25, 2023