Hearing ImpairedPhase 2NCT00037986
Functioning, Disability, and Quality of Life in the Adult Hearing Impaired
A Phase 2 study testing Hearing Aids in people with Hearing Impaired, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The short-term research objectives of the proposed study are as follows: 1. To measure the effects of audiological intervention on selected domain specific (i.e., Communicative, Interpersonal, and Social roles) and overall functioning using the WHO-DASII, a generic health measure conceptually grounded in the ICIDH-2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impaired
- What is being tested?
- Hearing Aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jun 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hearing impaired
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708
About this study
The short-term research objectives of the proposed study are as follows:
- To measure the effects of audiological intervention on selected domain specific (i.e., Communicative, Interpersonal, and Social roles) and overall functioning using the WHO-DASII, a generic health measure conceptually grounded in the ICIDH-2 model of disablement and functioning.
- To measure the effects of audiological intervention on selected domain specific (i.e., Role Functioning-Emotional; and, Social Functioning) and overall functioning using the MOS-SF36V, a generic health measure currently utilized in the Veteran's Health Administration.
- To determine the accuracy with which measures of audibility (SII), hearing handicap (HHIE), and, hearing disability (APHAB) predict domain specific and overall functioning, and life-satisfaction as measured by the WHO-DASII and the MOS-SF36V will be evaluated.
- To compare hearing aid treatment effects as measured by changes in WHO-DASII domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs.
- To compare hearing aid treatment effects as measured by changes in MOS-SF36V domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs.
- To determine and compare cost-effectiveness of hearing aid intervention as calculated using WHO-DASII and MOS SF-36V outcome data.
The long-term research objective is to compare the cost-effectiveness and cost-utility of audiologic intervention with those of other health care interventions commonly associated with the veteran population (e.g. mental health, cardiology, pulmonary, orthopedic, etc.).
Read the detailed description
Specific Objectives with Projected Timetable:
- . Short-term objectives:
- . To measure the effects of audiological intervention on selected domain specific (i.e., Communicative, Interpersonal, and Social roles) and overall functioning using the WHO-DAS II, a generic health measure conceptually grounded in the International Classification of Impairment, Disability, and Handicap (ICIDH)-2 model of disablement and functioning (WHO, 1999).
- . To measure the effects of audiological intervention on selected category specific (i.e., Role Functioning-Emotional and Social Functioning) and overall functioning using the MOS-SF36V, a generic health measure currently utilized in the Veterans Health Administration.
- . To determine the accuracy with which measures of audibility (SII), hearing handicap (HHIE), and, hearing disability (APHAB) predict domain specific and overall functioning, and life-satisfaction as measured by the WHO-DAS II and the MOS-SF36V will be evaluated.
- . To compare hearing aid treatment effects as measured by changes in WHO-DAS II domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs.
- . To compare hearing aid treatment effects as measured by changes in MOS-SF36V domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs.
- . To determine and compare cost-effectiveness of hearing aid intervention as calculated using WHO-DAS II and MOS-SF36V outcome data.
- . Long-term objective: To compare the cost-effectiveness and cost-utility of audiologic intervention with those of other health care interventions commonly associated with the veteran population (e.g. mental health, cardiology, pulmonary, orthopedic, etc.).
- Conditions
- Hearing Impaired
- Being tested
- Hearing Aids
- Keywords
- Audiology, Hearing, Hearing Aids, Quality of Life
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing AidsDevice
Hearing aid use
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Device: Hearing Aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO-DAS II
Measured: 2, 6, and 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2002 (estimated)
- Study startJul 2001
- Primary completionMay 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairedStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Harvey Abrams, PhD, Principal investigator, VA Medical Center, Bay Pines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037986
- Sponsor's protocol ID
- C2439R
- Status last verified
- Feb 2009
- First submitted
- 24 May 2002
- Last updated
- 11 Feb 2009
- Results posted
- No
Publications
Abrams HB, Chisolm TH, McArdle R. Health-related quality of life and hearing aids: a tutorial. Trends Amplif. 2005;9(3):99-109. doi: 10.1177/108471380500900302.
PubMed 16244757McArdle R, Chisolm TH, Abrams HB, Wilson RH, Doyle PJ. The WHO-DAS II: measuring outcomes of hearing aid intervention for adults. Trends Amplif. 2005;9(3):127-43. doi: 10.1177/108471380500900304.
PubMed 16244759Chisolm TH, Abrams HB, McArdle R, Wilson RH, Doyle PJ. The WHO-DAS II: psychometric properties in the measurement of functional health status in adults with acquired hearing loss. Trends Amplif. 2005;9(3):111-26. doi: 10.1177/108471380500900303.
PubMed 16244758
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functioning, Disability, and Quality of Life in the Adult Hearing Impaired
- ClinicalTrials.gov ID
- NCT00037986
- Acronym / sponsor ID
- C2439R
- Conditions
- Hearing Impaired
- Keywords
- Audiology, Hearing, Hearing Aids, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2001
- Primary completion
- May 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 27 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The short-term research objectives of the proposed study are as follows:
- To measure the effects of audiological intervention on selected domain specific (i.e., Communicative, Interpersonal, and Social roles) and overall functioning using the WHO-DASII, a generic health measure conceptually grounded in the ICIDH-2 model of disablement and functioning.
- To measure the effects of audiological intervention on selected domain specific (i.e., Role Functioning-Emotional; and, Social Functioning) and overall functioning using the MOS-SF36V, a generic health measure currently utilized in the Veteran's Health Administration.
- To determine the accuracy with which measures of audibility (SII), hearing handicap (HHIE), and, hearing disability (APHAB) predict domain specific and overall functioning, and life-satisfaction as measured by the WHO-DASII and the MOS-SF36V will be evaluated.
- To compare hearing aid treatment effects as measured by changes in WHO-DASII domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs.
- To compare hearing aid treatment effects as measured by changes in MOS-SF36V domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs.
- To determine and compare cost-effectiveness of hearing aid intervention as calculated using WHO-DASII and MOS SF-36V outcome data.
The long-term research objective is to compare the cost-effectiveness and cost-utility of audiologic intervention with those of other health care interventions commonly associated with the veteran population (e.g. mental health, cardiology, pulmonary, orthopedic, etc.).
Detailed description
Specific Objectives with Projected Timetable:
- . Short-term objectives:
- . To measure the effects of audiological intervention on selected domain specific (i.e., Communicative, Interpersonal, and Social roles) and overall functioning using the WHO-DAS II, a generic health measure conceptually grounded in the International Classification of Impairment, Disability, and Handicap (ICIDH)-2 model of disablement and functioning (WHO, 1999).
- . To measure the effects of audiological intervention on selected category specific (i.e., Role Functioning-Emotional and Social Functioning) and overall functioning using the MOS-SF36V, a generic health measure currently utilized in the Veterans Health Administration.
- . To determine the accuracy with which measures of audibility (SII), hearing handicap (HHIE), and, hearing disability (APHAB) predict domain specific and overall functioning, and life-satisfaction as measured by the WHO-DAS II and the MOS-SF36V will be evaluated.
- . To compare hearing aid treatment effects as measured by changes in WHO-DAS II domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs.
- . To compare hearing aid treatment effects as measured by changes in MOS-SF36V domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs.
- . To determine and compare cost-effectiveness of hearing aid intervention as calculated using WHO-DAS II and MOS-SF36V outcome data.
- . Long-term objective: To compare the cost-effectiveness and cost-utility of audiologic intervention with those of other health care interventions commonly associated with the veteran population (e.g. mental health, cardiology, pulmonary, orthopedic, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Hearing Aids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hearing impaired
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hearing AidsHearing aid use | Device | 1 |
Primary outcome
WHO-DAS II
Time frame: 2, 6, and 12 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2009.
- Results publication: PubMed 16244757Abrams HB, Chisolm TH, McArdle R. Health-related quality of life and hearing aids: a tutorial. Trends Amplif. 2005;9(3):99-109. doi: 10.1177/108471380500900302.
- Results publication: PubMed 16244759McArdle R, Chisolm TH, Abrams HB, Wilson RH, Doyle PJ. The WHO-DAS II: measuring outcomes of hearing aid intervention for adults. Trends Amplif. 2005;9(3):127-43. doi: 10.1177/108471380500900304.
- Results publication: PubMed 16244758Chisolm TH, Abrams HB, McArdle R, Wilson RH, Doyle PJ. The WHO-DAS II: psychometric properties in the measurement of functional health status in adults with acquired hearing loss. Trends Amplif. 2005;9(3):111-26. doi: 10.1177/108471380500900303.
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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.
Harvey Abrams, PhD principal investigator
VA Medical Center, Bay Pines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hearing Aids in people with Hearing Impaired, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 11 Feb 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WHO-DAS II (time frame: 2, 6, and 12 months post intervention). 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 NCT00037986, which also lists 3 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 11 Feb 2009.