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Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation

Primary Purpose

Hearing Impairment

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Information leaflets with illustrations about hearing aid functions
Information leaflets with only text about hearing aid functions
Sponsored by
Horselvarden Region Ostergotland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Impairment focused on measuring aural rehabilitation, hearing aid functions, hearing aid knowledge, information leaflet, visual aids

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hearing Clinic of the University Hospital Region Ostergotland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention group

Control group

Arm Description

Verbal information along with information leaflets containing text with illustrations about hearing aid functions

Verbal information along with information leaflets containing text-only about hearing aid functions

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2023
Last Updated
June 30, 2023
Sponsor
Horselvarden Region Ostergotland
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1. Study Identification

Unique Protocol Identification Number
NCT05936320
Brief Title
Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation
Official Title
A Randomised Controlled Trial Evaluating Hearing Aid Knowledge and the Effects of Information Leaflets With and Without Illustrations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment
Keywords
aural rehabilitation, hearing aid functions, hearing aid knowledge, information leaflet, visual aids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Verbal information along with information leaflets containing text with illustrations about hearing aid functions
Arm Title
Control group
Arm Type
Experimental
Arm Description
Verbal information along with information leaflets containing text-only about hearing aid functions
Intervention Type
Behavioral
Intervention Name(s)
Information leaflets with illustrations about hearing aid functions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Information leaflets with only text about hearing aid functions
Intervention Description
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 Outcome Measure Information:
Title
Knowledge about hearing aid functions
Description
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
Time Frame
Baseline, 3 weeks postintervention
Title
Perceived benefit
Description
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.
Time Frame
3 weeks postintervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
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
Hearing Clinic of the University Hospital Region Ostergotland
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation

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