Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation

Hearing Impairment Clinical Trial

Official title:

A Randomised Controlled Trial Evaluating Hearing Aid Knowledge and the Effects of Information Leaflets With and Without Illustrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05936320
• Other study ID #: Bildstöd
• Status: Completed
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: May 16, 2022

Study information

• Verified date: June 2023
• Source: Horselvarden Region Ostergotland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults (18-80 years old) with hearing aids from 2012 or later

Exclusion Criteria:

• Hearing aids without possibility to have activated directional microphones and telecoil

• non-swedish speaking (e.g. need interpreter)

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

Behavioral:
• Information leaflets with illustrations about hearing aid functions
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.
• Information leaflets with only text about hearing aid functions
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.

Locations

Country	Name	City	State
Sweden	Hearing Clinic of the University Hospital Region Ostergotland	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Horselvarden Region Ostergotland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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