DiabetesNCT00537264
A Comparison of Computerised Versus Interviewer-administered Approach for Assessing Health-related Quality of Life
A study testing Health-related quality of life assessment in people with Diabetes and Heart Disease, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The aim of this study is to compare a multimedia, computerised approach vs. interviewer administration of health-related quality of life (HRQoL) instruments. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes, Heart Disease, Hypertension
- What is being tested?
- Health-related quality of life assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2007to Jul 2008
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21 and above
- Singaporean citizens or permanent residents
- Speaks Mandarin
Who cannot join
- Patients who are mentally incapable of completing a questionnaire
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Geylang Polyclinic, 21 Geylang East Central
Singapore, 389707
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes, Heart Disease, Hypertension, Stroke
- Being tested
- Health-related quality of life assessment
- Keywords
- health-related quality of life, primary care, computer-assisted instruction
- Medical subject headings
- Diabetes Mellitus, Heart Diseases, Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-related quality of life assessmentOther
Also called Patient-reported outcomes
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.
Health-related quality of life assessmentOther
Also called Patient-reported outcomes
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.
| Study group | Role | What they receive |
|---|---|---|
| Computer | Experimental | Health-related quality of life questionnaires will be administered using a computerised multimedia touchscreen system. Receives: Other: Health-related quality of life assessment |
| Interviewer | Experimental | Health-related quality of life questionnaire will be administered via face-to-face interviews. Receives: Other: Health-related quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life outcomes
Measured: Past 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Julian Thumboo, FRCP (Edin), Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537264
- Sponsor's protocol ID
- 03/1/27/18/226
- Status last verified
- Apr 2018
- First submitted
- 28 Sep 2007
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1111/j.1524-4733.2006.00120.x.
PubMed 16961549
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Computer- Versus Interviewer-administered Approach for Assessing Health-related Quality of Life in Multi-Ethnic Singapore
- ClinicalTrials.gov ID
- NCT00537264
- Acronym / sponsor ID
- 03/1/27/18/226
- Conditions
- Diabetes, Heart Disease, Hypertension, Stroke
- Keywords
- health-related quality of life, primary care, computer-assisted instruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,800 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 1 Oct 2007 (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 aim of this study is to compare a multimedia, computerised approach vs. interviewer administration of health-related quality of life (HRQoL) instruments.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer | Experimental | Other: Health-related quality of life assessmentHealth-related quality of life questionnaires will be administered using a computerised multimedia touchscreen system. |
| Interviewer | Experimental | Other: Health-related quality of life assessmentHealth-related quality of life questionnaire will be administered via face-to-face interviews. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 21 and above
- Singaporean citizens or permanent residents
- Speaks Mandarin
Key exclusion criteria (1 listed)
- Patients who are mentally incapable of completing a questionnaire
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 |
|---|---|---|
| Health-related quality of life assessmentAlso: Patient-reported outcomesStudy 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 | Computer |
| Health-related quality of life assessmentAlso: Patient-reported outcomesStudy 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 | Interviewer |
Primary outcome
Health-related quality of life outcomes
Time frame: Past 4 weeks
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 18 Apr 2018.
- Background: PubMed 16961549Thumboo 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. doi: 10.1111/j.1524-4733.2006.00120.x.
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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.
Julian Thumboo, FRCP (Edin) principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-related quality of life assessment in people with Diabetes and Heart Disease, run by Singapore General Hospital at 1 site in Singapore.
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 3 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 18 Apr 2018. 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 Singapore. 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?
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?
Health-related quality of life outcomes (time frame: Past 4 weeks). 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 NCT00537264, which also lists 1 linked publication.
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 18 Apr 2018.