Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation
A Randomised Controlled Trial Evaluating Hearing Aid Knowledge and the Effects of Information Leaflets With and Without Illustrations
1 other identifier
interventional
61
1 country
1
Brief Summary
Knowledge about how to manage hearing aids is an important factor in hearing aid success, but studies show that this knowledge ranges from good to poor, even among experienced adult hearing aid users. Information leaflets is a common tool in healthcare to give information with the purpose to increase theoretical knowledge and change behaviour, and illustrations in these leaflets can provide additional understanding for all kinds of patients. The primary aim of this aural rehabiliation study was to evaluate participants' knowledge about placement in a noisy environment, directional microphone and telecoil function at baseline and postintervention and assessing their perceptions of the benefits of an information leaflet. Additional aim was to investigate whether, an information leaflet with illustrations and accompanying text about hearing aid functions have additional effects on participants' knowledge compared to an information leaflet without illustrations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2022
CompletedFirst Submitted
Initial submission to the registry
June 22, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedJuly 7, 2023
June 1, 2023
2.2 years
June 22, 2023
June 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Knowledge about hearing aid functions
Assessing change in knowledge about placement in noisy environments, telecoil function and directional microphones. Open-ended questions where the knowledge assessed by two authors independently of each other, to make the answers quantitative. Interrater reliability was analysed with Cohen's kappa
Baseline, 3 weeks postintervention
Perceived benefit
Assessing the perceived benefit of the information leaflet through three items formulated as statements and ranged from (0) not agree at all to (10) completely agree. The statements were as follows: 1) the written information I received has increased my understanding of the functions of the hearing aid, and 2) the written information I received has made me better understand how to position myself in different sound environments. If applicable, 3) the written information I received made it easier for me to explain the functions of my hearing aid to a communication partner.
3 weeks postintervention
Study Arms (2)
Intervention group
EXPERIMENTALVerbal information along with information leaflets containing text with illustrations about hearing aid functions
Control group
EXPERIMENTALVerbal information along with information leaflets containing text-only about hearing aid functions
Interventions
The information leaflet contains written information with simple illustrations about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes.
The information leaflet contains written information about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes.
Eligibility Criteria
You may qualify if:
- Adults (18-80 years old) with hearing aids from 2012 or later
You may not qualify if:
- Hearing aids without possibility to have activated directional microphones and telecoil
- non-swedish speaking (e.g. need interpreter)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hearing Clinic of the University Hospital Region Ostergotland
Linköping, Östergötland County, 58185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Öberg
Horselvarden Region Ostergotland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2023
First Posted
July 7, 2023
Study Start
February 25, 2020
Primary Completion
May 16, 2022
Study Completion
May 16, 2022
Last Updated
July 7, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share