Hearing LossNCT01843777

Applying the Use of Motivational Tools to Auditory Rehabilitation

A study testing Standard-of-Care and Treatment in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Loss
What is being tested?: Standard-of-Care and Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Nov 2013to Mar 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

be aged between 20 and 89 years
be a first-time hearing-aid user
air-conduction pure-tone averages (mean thresholds at 500 Hz, 1000 Hz, and 2000 Hz) of 70 dB HL or less in both ears
word-recognition scores of 40% or better in each ear
English as their first language
have sufficient vision and reading ability

Show all 11Show fewer

have the appropriate cognitive skills to participate in the study as determined by the Mini Mental State Exam, 2nd Edition - Brief Version (Folstein et al., 2010)
have been fit by the VA Portland Health Care System Audiology and Speech Pathology Service (ASPS) with two hearing aids which have datalogging capabilities
be independent in their completion of activities in daily living, as determined by their score on the Katz Index of Independence in Activities of Daily Living (Katz et al., 1970)
have poor adoption of their hearing aids
be free of a documented diagnosis in the VA Computerized Patient Record System (CPRS) record of neurological or psychological disorder, such as Alzheimer's disease, schizophrenia, or uncontrolled substance abuse, which would interfere with the completion of the study. Vulnerable populations are not being studied.

Who cannot join

Failure to satisfy any of the requirements listed as inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239

Other trials in United States

About this study

The purpose of this study is to compare two different ways of helping first-time hearing-aid users get the most out of their hearing aids and determine if one method is better than the other. One method provides the patient with routine information regarding the care and use of hearing aids the other method uses tools to address patient-specific barriers against and motivators for hearing-aid use.

Conditions: Hearing Loss
Being tested: Standard-of-Care, Treatment
Keywords: hearing loss, hearing aids, motivational interviewing, counseling, rehabilitation
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard-of-CareBehavioural
the standard of care in audiologic practice
TreatmentBehavioural
Also called Motivational Interviewing
motivational interviewing

Study groups in NCT01843777
Study group	Role	What they receive
Standard-of-Care	Active comparator	The "standard-of-care" control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids. Receives: Behavioral: Standard-of-Care
Treatment	Experimental	The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing. Receives: Behavioral: Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention
Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points.
Measured: Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date

Secondary outcomes (1)

Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids
The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points.
Measured: Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Mar 2015

First posted1 May 2013 (estimated)
Study startNov 2013
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hearing LossStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01843777
Sponsor's protocol ID: C1004-P
Status last verified: Oct 2016
First submitted: 23 Apr 2013
Last updated: 7 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.
PubMed 5420677
Cox RM, Stephens D, Kramer SE. Translations of the International Outcome inventory for Hearing Aids (IOI-HA). Int J Audiol. 2002 Jan;41(1):3-26. doi: 10.3109/14992020209101307. No abstract available.
PubMed 12467365

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Applying the Use of Motivational Tools to Auditory Rehabilitation
ClinicalTrials.gov ID: NCT01843777
Acronym / sponsor ID: C1004-P
Conditions: Hearing Loss
Keywords: hearing loss, hearing aids, motivational interviewing, counseling, rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Nov 2013
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 1 May 2013 (estimated)
Results: Posted 7 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard-of-Care	Active comparator	Behavioral: Standard-of-CareThe "standard-of-care" control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.
Treatment	Experimental	Behavioral: TreatmentThe treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.

Who may qualify

Ages: 20 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

be aged between 20 and 89 years
be a first-time hearing-aid user
air-conduction pure-tone averages (mean thresholds at 500 Hz, 1000 Hz, and 2000 Hz) of 70 dB HL or less in both ears
word-recognition scores of 40% or better in each ear
English as their first language

Key exclusion criteria (1 listed)

Failure to satisfy any of the requirements listed as inclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard-of-Carethe standard of care in audiologic practice	Behavioural	Standard-of-Care
TreatmentAlso: Motivational Interviewingmotivational interviewing	Behavioural	Treatment

Primary outcome

Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention
Time frame: Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date
Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points.

1 secondary outcome

Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids
Time frame: Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention

Results and safety

Results posted to the registry on 7 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard-of-Care	11	10
Treatment	10	10

Primary outcome: Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention

Time frame: Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date. Mean (Standard Deviation). Unit: hours

Measure	Standard-of-Care n = 9	Treatment n = 5
Value	-2.1 (3.3)	2.2 (3.3)

Population analysed: Standard-of-care group: one subject withdrew prior to the collection of outcome measures and one subject did not give valid data log measurement. These subjects are not included. Treatment: Three subjects did not give valid outcome data log measurement and one did not give a valid baseline measure. These subjects are not included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: This was a minimal risk study. Adverse events were only monitored during study visits.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard-of-Care	0 of 11 (0%)	0 of 11 (0%)	Not reported
Treatment	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 5420677Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.
Results publication: PubMed 12467365Cox RM, Stephens D, Kramer SE. Translations of the International Outcome inventory for Hearing Aids (IOI-HA). Int J Audiol. 2002 Jan;41(1):3-26. doi: 10.3109/14992020209101307. No abstract available.
Individual participant dataSharing planned: No

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RecruitingObservational study
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HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
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Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

M. Samantha Lewis, PhD principal investigator

VA Portland Health Care System, Portland, OR

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard-of-Care and Treatment in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention (time frame: Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843777, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.