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| Tracking Information | |||||
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| First Received Date ICMJE | May 24, 2002 | ||||
| Last Updated Date | February 9, 2009 | ||||
| Start Date ICMJE | July 2001 | ||||
| Primary Completion Date | May 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
WHO-DAS II [ Time Frame: 2, 6, and 12 months post intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00037986 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Functioning, Disability, and Quality of Life in the Adult Hearing Impaired | ||||
| Official Title ICMJE | Functioning, Disability, and Quality of Life in the Adult Hearing Impaired | ||||
| Brief Summary | The short-term research objectives of the proposed study are as follows:
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.). |
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| Detailed Description | Specific Objectives with Projected Timetable:
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Hearing Impaired | ||||
| Intervention ICMJE | Device: Hearing Aids | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 330 | ||||
| Completion Date | June 2004 | ||||
| Primary Completion Date | May 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Hearing impaired Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00037986 | ||||
| Responsible Party | Abrams, Harvey - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | C2439R | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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