Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000504314
Ethics application status
Approved
Date submitted
19/08/2016
Date registered
6/04/2017
Date last updated
6/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self Care Practices in Elderly with Diabetes: Association with Stress and Cost Analysis
Scientific title
Self care practices in Elderly with Diabetes: Association with Diabetic-related Distress and A review of Cost Analysis
Secondary ID [1] 289973 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 299975 0
Diabetes-related Distress 299976 0
Condition category
Condition code
Metabolic and Endocrine 299867 299867 0 0
Diabetes
Mental Health 299874 299874 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To determine the diabetic self-care and distress level in elderly diabetic patient. Each participant was assessed once. The duration of data collection was started from26/03/2015 until 30/07/2015.
Intervention code [1] 295672 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299351 0
Total Diabetic Distress Score
Timepoint [1] 299351 0
This is a cross-sectional study and the assessment was only done once.
Primary outcome [2] 299352 0
Total Diabetes Self-Management Score
Timepoint [2] 299352 0
This is a cross-sectional study and the assessment was only done once.
Secondary outcome [1] 326906 0
Assessment was done through self-administered questionnaire designed to assess diabetic distress for this study.
Timepoint [1] 326906 0
This is a cross-sectional study and the assessment was only done once.
Secondary outcome [2] 333409 0
Assessment was done through self-administered questionnaire designed for healthcare cost in elderly in this study.
Timepoint [2] 333409 0
This is a cross-sectional study and the assessment was only done once.

Eligibility
Key inclusion criteria
60 years old and above with Type two Diabetes, diagnosed minimum of three months
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Mentally impaired
2. Illiterate
3. Having life-threatening condition

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size was determined by Kish Lwanga formula. Sample size calculated was 229.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/03/2015
Date of last participant enrolment
Anticipated
Actual
30/07/2015
Date of last data collection
Anticipated
Actual
30/07/2015
Sample size
Target
229
Accrual to date
Final
248
Recruitment outside Australia
Country [1] 8115 0
Malaysia
State/province [1] 8115 0
Wilayah Persekutuan Kuala Lumpur

Funding & Sponsors
Funding source category [1] 294349 0
University
Name [1] 294349 0
Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center
Country [1] 294349 0
Malaysia
Primary sponsor type
University
Name
Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center
Address
Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center, Jalan Yaacob Latif, Bandar Tun Razak, 56000, Cheras, Kuala Lumpur, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 293187 0
None
Name [1] 293187 0
Address [1] 293187 0
Country [1] 293187 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295766 0
Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center
Ethics committee address [1] 295766 0
Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center, Jalan Yaacob Latif, Bandar Tun Razak, 56000, Cheras, Kuala Lumpur, Malaysia.
Ethics committee country [1] 295766 0
Malaysia
Date submitted for ethics approval [1] 295766 0
19/01/2015
Approval date [1] 295766 0
23/03/2015
Ethics approval number [1] 295766 0
FF-2015-107

Summary
Brief summary
BACKGROUND AND AIMS: Diabetes is highly prevalent among elderly. Elderly diabetic patients may suffer from many complications from diabetes and other chronic diseases. This may lead to distress and interfere with their self-care. The aim of the study was to assess self-care and level of distress among elderly patients with diabetes

MATERIALS AND METHODS: A cross-sectional study involving 248 elderly Type II diabetes patients in primary care clinic. Convenient random sampling method was used. Data on socio-demographic and clinical characteristic (i.e. HbA1c, BMI) was obtained. The Diabetes Self Management Questionnaire (DSMQ) and Diabetes Distress Scale (DDS) were used to measure diabetes related distress and self-care respectively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68390 0
Dr Syahnaz Mohd Hashim
Address 68390 0
Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 68390 0
Malaysia
Phone 68390 0
+603-91456117
Fax 68390 0
Email 68390 0
[email protected]
Contact person for public queries
Name 68391 0
Syahnaz Mohd Hashim
Address 68391 0
Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 68391 0
Malaysia
Phone 68391 0
+603-91456117
Fax 68391 0
Email 68391 0
[email protected]
Contact person for scientific queries
Name 68392 0
Syahnaz Mohd Hashim
Address 68392 0
Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 68392 0
Malaysia
Phone 68392 0
+603-91456117
Fax 68392 0
Email 68392 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.