Educational Program for Hearing Aid Users With Internet Support

NCT01837550 | Completed Results DMC

• 1 other identifier: HörNet VGR
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the short-term effects of complementing an educational program for hearing aid users with Internet support.

Conditions

Hearing Impaired

Keywords

audiologic rehabilitation; hearing loss; patient education; patient participation; structured rehabilitation; counseling; Internet

Outcome Measures

Primary Outcomes (1)

• The Hearing Handicap Inventory for the Elderly (HHIE)

  The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.

  5 weeks, 6 months

Secondary Outcomes (3)

• International Outcome Inventory for Hearing Aids (IOI-HA)

  pre-measurement

• Hospital Anxiety and Depression Scale (HADS)

  5 weeks, 6 months

• Communication Strategies Scale (CSS)

  5 weeks, 6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

no professional support

Behavioral: Intervention group

Intervention group

EXPERIMENTAL

Professional support via Internet

Behavioral: Control group

Interventions

Control group BEHAVIORAL

The control group only had access to reading material.

Intervention group

Intervention group BEHAVIORAL

The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum.

Control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the hearing aid users to be between 20 and 80 yr of age,
• the hearing aid users to have conductive or sensorineural hearing loss of mild to moderate degree (20-60 decibel Hearing Level pure-tone average measured across 500, 1000, and 2000 Hertz),
• the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
• the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of \>20 points (indicative of some residual self-reported hearing problems),
• the hearing aid users to provide informed consent to participate

You may not qualify if:

• the hearing aid users who are not fulfilling the conditions to participate

Sponsors & Collaborators

• Sodra Alvsborgs Hospital: lead

Study Sites (1)

Hearing Clinic, Hearing Organization

Borås, Vastra Gotalandsregion, 501 82, Sweden

Location

Related Publications (1)

• Malmberg M, Lunner T, Kahari K, Andersson G. Evaluating the short-term and long-term effects of an internet-based aural rehabilitation programme for hearing aid users in general clinical practice: a randomised controlled trial. BMJ Open. 2017 Jun 6;7(5):e013047. doi: 10.1136/bmjopen-2016-013047.

  PMID: 28592571 DERIVED

MeSH Terms

Conditions

Hearing Loss; Patient Participation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Milijana Malmberg, PhD student
• Organization: Sodra Alvsborg, Hearing Organisation

milijana.lundberg.malmberg@vgregion.se

0046 703 80 36 63

Study Officials

• Gerhard Andersson, Professor

  Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.

  PRINCIPAL INVESTIGATOR

• Thomas Lunner, Professor

  Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Principal Investigator

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 25, 2016
• Results First Posted: April 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)