Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000564257
Ethics application status
Approved
Date submitted
16/03/2018
Date registered
13/04/2018
Date last updated
6/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in health, nutritional, functional and mental status, hospitalisation and quality of life among community-living older people in Yogyakarta, Indonesia.
Scientific title
Changes in health, nutritional, functional and mental status, hospitalisation and quality of life among community-living older people in Yogyakarta, Indonesia.
Secondary ID [1] 294371 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow up of baseline study titled : “Determinants of nutritional status among older people living in urban and rural area of Yogyakarta, Indonesia” (trial ID ACTRN12616000260426). The current study will investigate changes in outcome parameters after 2.5 years.

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 307103 0
Condition category
Condition code
Diet and Nutrition 306212 306212 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
This research project represents follow-up of the project titled “Determinants of nutritional status among older people living in urban and rural area of Yogyakarta, Indonesia” which was approved by Medical and Health Research Ethics Committee, Faculty of Medicine, Universitas Gadjah Mada, Indonesia. Approval number: KE/FK/1177/EC/2015;Approval Date: 14 September 2015.
This longitudinal project aims to investigate the changes in health, nutritional, functional and mental status, hospitalization and quality of life of community-living older people over 5 years. It is expected that the findings from this project will provide crucial evidence on the deleterious impact cognitive impairment and nutritional status among older people Indonesian. The research team will conduct similar survey every 2.5 years for next 5 years. The survey will involve interview using structured questionnaire, blood sample collection, anthropocentric and physical assessment.
Intervention code [1] 300675 0
Early Detection / Screening
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305224 0
Nutritional status as assessed by Mini Nutritional Assessment (MNA)
Timepoint [1] 305224 0
0 years
2.5 Years
5 years (primary endpoint)
Primary outcome [2] 305225 0
Frailty measured by Fatigue, resistance, aerobic, illness, and loss of weight Scale (FRAIL)
Timepoint [2] 305225 0
0 years
2.5 Years
5 years (Primary endpoint).
Primary outcome [3] 305226 0
Mortality based on information from civil registry, cadre and family members.
Timepoint [3] 305226 0
2.5 Years
5 years (Primary endpoint).
Secondary outcome [1] 344536 0
Physical Activity and muscle function measured by Short physical performance battery (including handgrip strength, 3-m walk test, chair stand test, balance test), six minutes walk, timed up and go, Instrumental Activity Daily of Living (IADL), and Activities of Daily of Living (ADL), International Physical Activity Questionnaire (IPAQ) (composite outcome).
Timepoint [1] 344536 0
0 years
2.5 Years
5 years
Secondary outcome [2] 344537 0
Mental status measured by Geriatric Depression Scale (GDS)
Timepoint [2] 344537 0
0 years
2.5 Years
5 years
Secondary outcome [3] 344538 0
Food intake and dietary habits measured by validated Semi Quantitative-Food Frequency Questionnaire (SQFFQ) and 24-hour recall (composite outcome).
Timepoint [3] 344538 0
0 years
2.5 Years
5 years
Secondary outcome [4] 344539 0
Food supply and food security measured by structured questionnaire designed specifically for this study (composite outcome).
Timepoint [4] 344539 0
0 years
2.5 Years
5 years
Secondary outcome [5] 344540 0
Body composition measured by Bioelectrical impedance Analysis (BIA)and Skinfold thickness at 4 points (triceps, biceps, sub-scapula, supra-iliaca)
Timepoint [5] 344540 0
0 years
2.5 Years
5 years
Secondary outcome [6] 344965 0
Hospitalisation measured by frequency of hospital admission over the pas 6 months, and length of stay.
Timepoint [6] 344965 0
0 year
2.5 Years
5 years
Secondary outcome [7] 345133 0
Cognitive function by Mini Mental State Examination scale (MMSE).
Timepoint [7] 345133 0
0 year
2.5 Years
5 years
Secondary outcome [8] 345456 0
Nutritional status as assessed by anthropometry (BMI, Mid-arm Muscle Area/AMA)
Timepoint [8] 345456 0
0 year
2.5 Years
5 years
Secondary outcome [9] 345458 0
Nutritional status assessed by biochemical parameters (albumin, serum CRP and interleukins i.e IL-1b, IL-6, IL-10,TNFa, IL-4, IFNg)
Timepoint [9] 345458 0
0 year
2.5 Years
5 years

Eligibility
Key inclusion criteria
1. Men and women aged greater or equal to 65 years.
2. Had been living in Yogyakarta for at least 1 year prior to the study.
3. Able to communicate with the investigator and understand the study protocol.
4. Involved in the preliminary study.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to comprehend study protocol or confirmed diagnosis of severe dementia by GP.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be performed using SPSS (Version 22.0 for Windows, IBM, New York, NY,USA). Prior to analysis, data will be cleaned and checked for outliers. Two member of the research team will recheck hard copy data to clarify any identified outliers and missing values. Furthermore, skewness, kurtosis, histogram with normal curve, stem and leaf plot, and Kolomogorov-Smirnov tests were performed on numeric variables to determine normality. Results will be presented as means and standard deviations (SD), unless stated otherwise, for all participants and a breakdown by urban and rural areas. Logistic, ordinal and multinomial regressions will be used to determine the effects of location (urban vs rural), gender and location by gender interaction on socio-demographic and health characteristics. ANCOVA will be used to examine the effects of location, gender and location by gender interaction on anthropometric characteristics, nutrient intake, blood parameters, frailty, physical and mental function, and mortality.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/04/2018
Actual
14/04/2018
Date of last participant enrolment
Anticipated
3/04/2023
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
527
Accrual to date
343
Final
Recruitment outside Australia
Country [1] 10224 0
Indonesia
State/province [1] 10224 0
The Special Region of Yogyakarta

Funding & Sponsors
Funding source category [1] 299012 0
University
Name [1] 299012 0
Universitas Gadjah Mada
Country [1] 299012 0
Indonesia
Primary sponsor type
University
Name
University of Adelaide
Address
AHMS Building, North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 298238 0
Government body
Name [1] 298238 0
CSIRO
Address [1] 298238 0
SAHMRI Building, North Terrace, Adelaide SA 5000
Country [1] 298238 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299950 0
Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine, Gadjah Mada University - Dr. Sardjito General Hospital
Ethics committee address [1] 299950 0
Ethics committee country [1] 299950 0
Indonesia
Date submitted for ethics approval [1] 299950 0
16/02/2018
Approval date [1] 299950 0
13/04/2018
Ethics approval number [1] 299950 0
KE/FK/0327/EC/2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2759 2759 0 0
/AnzctrAttachments/374749-Ethical Clearance.pdf (Ethics approval)

Contacts
Principal investigator
Name 82054 0
Dr Tony Arjuna
Address 82054 0
Endeavour Postdoctoral Research Fellow
AHMS Building Level 5, North Terrace, Adelaide, SA 5000
Country 82054 0
Australia
Phone 82054 0
+61883136095
Fax 82054 0
Email 82054 0
[email protected]
Contact person for public queries
Name 82055 0
Tony Arjuna
Address 82055 0
Discipline of Medicine and Centre of Research Excellence in Translating Nutritional Science to Good Health
AHMS Building Level 5, North Terrace, Adelaide, SA 5000
Country 82055 0
Australia
Phone 82055 0
+61883136095
Fax 82055 0
Email 82055 0
[email protected]
Contact person for scientific queries
Name 82056 0
Tony Arjuna
Address 82056 0
Discipline of Medicine and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide
AHMS Building Level 5, North Terrace, Adelaide, SA 5000
Country 82056 0
Australia
Phone 82056 0
+61883136095
Fax 82056 0
Email 82056 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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