Back to resultsEffects of an Online Hearing Support for First-time Hearing Aid Users
Primary Purpose
Hearing Loss, Hearing Impairment, Hearing Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Online hearing support for first-time hearing aid users
Hearing rehabilitation according to common practice.
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
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
Sites / Locations
- Audiologimottagningen Lund
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Participants get hearing rehabilitation according to common practice and the online hearing support.
Participants get hearing rehabilitation according to common practice.
Outcomes
Primary Outcome Measures
The Hearing Handicap Inventory for the Elderly (HHIE)
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
The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
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.
Communication Strategies Scale (CSS)
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.
The International Outcome Inventory for Hearing Aids (IOI-HA)
Assessing changes in perceived effectiveness and satisfaction with hearing aids.
Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.
Full Information
NCT ID
NCT06051968
First Posted
September 18, 2023
Last Updated
October 16, 2023
Sponsor
Region Skane
Collaborators
Horselvarden Region Ostergotland
1. Study Identification
Unique Protocol Identification Number
NCT06051968
Brief Title
Effects of an Online Hearing Support for First-time Hearing Aid Users
Official Title
Effects of an Online Hearing Rehabilitation Support for First-time Hearing Aid Users: A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Horselvarden Region Ostergotland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Hearing Impairment, Hearing Disorders, Hearing Disability, Ear Diseases, Sensation Disorders, Otorhinolaryngologic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants get hearing rehabilitation according to common practice and the online hearing support.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants get hearing rehabilitation according to common practice.
Intervention Type
Behavioral
Intervention Name(s)
Online hearing support for first-time hearing aid users
Other Intervention Name(s)
Stöd och Behandling för nya hörapparatanvändare, Internetbaserat stöd vid hörselrehabilitering
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hearing rehabilitation according to common practice.
Intervention Description
Participants get hearing rehabilitation according to common practice.
Primary Outcome Measure Information:
Title
The Hearing Handicap Inventory for the Elderly (HHIE)
Description
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.
Time Frame
Baseline, directly post intervention and 6 months post intervention.
Secondary Outcome Measure Information:
Title
The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
Description
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.
Time Frame
Baseline, directly post intervention and 6 months post intervention.
Title
Communication Strategies Scale (CSS)
Description
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.
Time Frame
Baseline, directly post intervention and 6 months post intervention.
Title
The International Outcome Inventory for Hearing Aids (IOI-HA)
Description
Assessing changes in perceived effectiveness and satisfaction with hearing aids.
Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.
Time Frame
Directly post intervention and 6 months post intervention.
Other Pre-specified Outcome Measures:
Title
Subjective impact of the intervention, reported by the users: Memory of the intervention
Description
The participants are asked what they remember from their intervention.
Time Frame
6 months post intervention
Title
Subjective impact of the intervention, reported by the users: Seeking more or other information
Description
The participants are asked if they searched for more or other information about hearing or hearing aids.
Time Frame
6 months post intervention
Title
Subjective impact of the intervention, reported by the users: Adverse effects
Description
The participants are asked if they experienced any adverse effects of the intervention.
Time Frame
6 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Öberg
Organizational Affiliation
Horselvarden Region Ostergotland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Audiologimottagningen Lund
City
Lund
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of an Online Hearing Support for First-time Hearing Aid Users
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