NCT02233361

Brief Summary

The proportion of elderly people is expected to increase greatly within the next couple of decades, resulting in a proportional increase in the need for hearing rehabilitation. However, studies suggest that as many as 40% of hearing aids are never or seldom used. Thus, a major challenge for audiological rehabilitation is facilitating the use of fitted hearing aids. This study has four objectives; 1) to evaluate the effect of advanced notice of a follow-up appointment on hearing aid use, 2) to implement a specialized counselling program based on MI, 3) to identify barriers to hearing aid use, and 4) to objectively assess hearing aid use with datalogging technology.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

August 13, 2014

Last Update Submit

September 3, 2014

Conditions

Keywords

Hearing rehabilitationElderlyHearing aid use

Outcome Measures

Primary Outcomes (1)

  • The effect of follow-up appointments on hearing aid use

    The counseling utilize Motivational Interviewing (MI) to promote hearing aid use. Datalogging will be used to assess changes in hearing aid use.

    1 year

Secondary Outcomes (1)

  • Hearing aid use measured with datalogging technology

    When signed for the hearing aid and six month later

Other Outcomes (1)

  • Factor Barriers to hearing aid use

    At the follow up appointment. Six month after the hearing aid was assigned for.

Study Arms (2)

Counseling

EXPERIMENTAL

The intervention group will be informed in advance of a follow-up appointment six month after they have received their hearing aid. They will know that support will be given and time-use of the hearing aid will be checked out. Counseling on hearing aid use will be given.

Behavioral: Counseling

Counselling

NO INTERVENTION

The control group will not receive any information of a follow-up appointment. However, they will receive a notice on this after six month.

Interventions

CounselingBEHAVIORAL

A randomized controlled design will determine whether hearing aid users who are informed in advance of a follow-up appointment have a different pattern of hearing aid use than a control group that is not preinformed in advance.

Counseling

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 + years old
  • Subjective and objective need for hearing aids.

You may not qualify if:

  • Not being able to communicate in Norwegian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diakonale Hospital

Oslo, 0456, Norway

RECRUITING

MeSH Terms

Conditions

Presbycusis

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jorunn Solheim, Ph.d.

    Lovisenberg Diakonale Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorunn Solheim, Ph.d.

CONTACT

Kari Kvaerner, Ph.d.

CONTACT

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
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

September 8, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations