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Completed

NCT Number: NCT05936320

Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation

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.

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Key information

Conditions

Hearing Impairment Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearing Clinic of the University Hospital Region Ostergotland

Linköping, Östergötland County, 58185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Information leaflets with illustrations about hearing aid functions

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Knowledge about hearing aid functions

    Time frame: Baseline, 3 weeks postintervention

    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

  2. Perceived benefit

    Time frame: 3 weeks postintervention

    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.

Sponsors and collaborators

Lead sponsor

Horselvarden Region Ostergotland

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2023
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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