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| Tracking Information | |||||||||
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| First Received Date † | September 28, 2007 | ||||||||
| Last Updated Date | January 15, 2009 | ||||||||
| Start Date † | November 2007 | ||||||||
| Current Primary Outcome Measures † |
Health-related quality of life outcomes [ Time Frame: Past 4 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00537264 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | A Comparison of Computerised Versus Interviewer-Administered Approach for Assessing Health-Related Quality of Life | ||||||||
| Official Title † | A Randomized Controlled Trial Comparing Computer- Versus Interviewer-Administered Approach for Assessing Health-Related Quality of Life in Multi-Ethnic Singapore | ||||||||
| Brief Summary | The aim of this study is to compare a multimedia, computerised approach vs. interviewer administration of health-related quality of life (HRQoL) instruments. |
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| Detailed Description | There are no drug treatments involved in this study. The administration of health-related quality of life questionnaires is the intervention being studied. Health-related quality of life questionnaires measure the physical, mental and social well-being of an individual, are recognised as important patient-reported outcomes and are increasingly being used in clinical trials and routine clinical practice. By asking study participants to complete a questionnaire assessing their physical, mental and social well-being, we are increasing their awareness of these aspects of their health and may directly or indirectly prompt them to take actions and/ or have thoughts that may improve or worsen their health status. Hence, we have considered this an interventional study. This survey will be conducted in Chinese. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment | ||||||||
| Condition † |
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| Intervention † |
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| Study Arms / Comparison Groups |
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| Publications * | Thumboo J, Wee HL, Cheung YB, Machin D, Luo N, Fong KY. Development of a Smiling Touchscreen multimedia program for HRQoL assessment in subjects with varying levels of literacy. Value Health. 2006 Sep-Oct;9(5):312-9. | ||||||||
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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 † | Recruiting | ||||||||
| Enrollment † | 5000 | ||||||||
| Estimated Completion Date | July 2008 | ||||||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Singapore | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00537264 | ||||||||
| Responsible Party | A/P Julian Thumboo, Singapore General Hospital | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Singapore General Hospital | ||||||||
| Collaborators †† | National University, Singapore | ||||||||
| Investigators † |
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| Information Provided By | Singapore General Hospital | ||||||||
| Verification Date | April 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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