- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537264
A Comparison of Computerised Versus Interviewer-administered Approach for Assessing Health-related Quality of Life
April 16, 2018 updated by: Singapore General Hospital
A Randomized Controlled Trial Comparing Computer- Versus Interviewer-administered Approach for Assessing Health-related Quality of Life in Multi-Ethnic Singapore
The aim of this study is to compare a multimedia, computerised approach vs. interviewer administration of health-related quality of life (HRQoL) instruments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
4800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore, 389707
- Geylang Polyclinic, 21 Geylang East Central
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 21 and above
- Singaporean citizens or permanent residents
- Speaks Mandarin
Exclusion Criteria:
- Patients who are mentally incapable of completing a questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computer
Health-related quality of life questionnaires will be administered using a computerised multimedia touchscreen system.
|
Study participants will be asked to complete the following health-related quality of life questionnaires: EQ-5D, Health Utilities Index 3, SF-8 and SF-6D.
The Singapore (Chinese) versions of these questionnaires have been previously tested and validated in a pilot cohort of the same study population.
Other Names:
|
Experimental: Interviewer
Health-related quality of life questionnaire will be administered via face-to-face interviews.
|
Study participants will be asked to complete the following health-related quality of life questionnaires: EQ-5D, Health Utilities Index 3, SF-8 and SF-6D.
The Singapore (Chinese) versions of these questionnaires have been previously tested and validated in a pilot cohort of the same study population.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health-related quality of life outcomes
Time Frame: Past 4 weeks
|
Past 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julian Thumboo, FRCP (Edin), Singapore General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
September 28, 2007
First Submitted That Met QC Criteria
September 28, 2007
First Posted (Estimate)
October 1, 2007
Study Record Updates
Last Update Posted (Actual)
April 18, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03/1/27/18/226
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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