Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001121853
Ethics application status
Approved
Date submitted
18/10/2012
Date registered
19/10/2012
Date last updated
19/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Asian Diabetes Quality of Life Study (AD-QOL)
Scientific title
Development, validation of a new quality of life assessment tool in type 2 diabetes and cross-sectional study to assess the quality of life among diabetics in Malaysia
Secondary ID [1] 281412 0
NIL
Universal Trial Number (UTN)
U1111-1136-0270
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 287659 0
Condition category
Condition code
Metabolic and Endocrine 287997 287997 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
observational study for 12 months:
At visit one, subject's quality of life will be assessed using the new tool (AD-QOL), their baseline blood results will be charted ( fasting blood sugar and glycated hemoglobin HBA1C levels). Subject will be given the standard medical care from their respective care-givers. The same procedure will be done at 6 months and 12 months interval.
Intervention code [1] 285902 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288210 0
Quality of life assessment score using the newly developed Asian Diabetes Quality of Life questionnaire
Timepoint [1] 288210 0
First visit, 6 months and 12 months
Secondary outcome [1] 299614 0
Glycated haemoglobin level (HBA1C)
Timepoint [1] 299614 0
First visit, 6 months and 12 months

Eligibility
Key inclusion criteria
Subjects diagnosed with Type 2 diabetes, with or without pharmacological treatment.
Subjects above the age of 18 and below the age of 80.
Subjects whom have completed secondary education (12 years of formal education) so as to be able to understand the contents of the questionnaire
Subjects who are able to give written consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with concurrent Parkinson’s disease, Alzheimer’s disease, dementia, severe visual impairment.

Subjects less than 18 years of age or more than 80 years of age.

Subjects whom have not completed 12 years of formal education.

Subjects with mental illness impairing judgment who will be unable to give valid consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment outside Australia
Country [1] 4610 0
Malaysia
State/province [1] 4610 0
Kuala Lumpur
Country [2] 4611 0
Malaysia
State/province [2] 4611 0
Johor Bahru

Funding & Sponsors
Funding source category [1] 286175 0
University
Name [1] 286175 0
Monash University Malaysia
Country [1] 286175 0
Malaysia
Primary sponsor type
Individual
Name
Dr.Shereen Goh Giap Kah
Address
1, Jalan BU1/14,
Bandar Utama,
47800, Selangor
Country
Malaysia
Secondary sponsor category [1] 284986 0
Individual
Name [1] 284986 0
Prof. Dr. Rusli Bin Nordin
Address [1] 284986 0
Jalan Lagoon Selatan,
Bandar Sunway,46150 Selangor
Country [1] 284986 0
Malaysia
Secondary sponsor category [2] 284987 0
Individual
Name [2] 284987 0
Prof.Dr. Khalid Abdul Kadir
Address [2] 284987 0
Jalan Lagoon Selatan,
Bandar Sunway,46150 Selangor
Country [2] 284987 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288241 0
Monash University Human Research Ethics (MUHREC)
Ethics committee address [1] 288241 0
Monash University,
Building 3E, Room 111, Clayton Campus, Wellington Road, Clayton Vic 3800, Australia
Ethics committee country [1] 288241 0
Australia
Date submitted for ethics approval [1] 288241 0
Approval date [1] 288241 0
28/03/2012
Ethics approval number [1] 288241 0
CF2630 - 2011001537

Summary
Brief summary
Objectives:
1)
The primary objective is to conduct a survey to assess the suitability of current available quality of life questionnaires for use in our local Malaysian diabetic population.
2) To develop and validate a socially and culturally adapted quality of life measurement scale to successfully measure the quality of life among Malaysian diabetic population that can be projected to the Asian population in the future.
3) To measure the QOL among Malaysian diabetics and to analyze the factors that contributes to determining QOL.
4) To determine if diabetes control is an important factor for QOL using a perspective study.
5) To measure QOL in other south-east Asia countries using the newly developed ADQOL and to compare with Malaysian population.

Methodology
The study is divided into 5 main parts as follows:
I. Survey to assess the understanding of the local population to the current available quality of life assessment tools.
II. The development and validation of the Asian Diabetes Quality of Life (AD-QOL) questionnaire to accurately measure the quality of life in a multi-cultural, multi-language population.
III. Cross-sectional study to assess the QOL among diabetics in Malaysia using AD-QOL.
IV. Prospective study of diabetics in Malaysia
V. Cross countries study of QOL among diabetics using ADQOL.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 34849 0
Address 34849 0
Country 34849 0
Phone 34849 0
Fax 34849 0
Email 34849 0
Contact person for public queries
Name 18096 0
Dr.Shereen Goh
Address 18096 0
20&22, PJS 11/5, Bandar Sunway, 46150 Petaling Jaya, Selangor
Country 18096 0
Malaysia
Phone 18096 0
+60123397825
Fax 18096 0
+60356211625
Email 18096 0
[email protected]
Contact person for scientific queries
Name 9024 0
Prof. Khalid Abdul Kadir
Address 9024 0
20&22, PJS 11/5, Bandar Sunway, 46150 Petaling Jaya, Selangor
Country 9024 0
Malaysia
Phone 9024 0
+60356211623
Fax 9024 0
+60356211625
Email 9024 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.