Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000661572
Ethics application status
Approved
Date submitted
14/06/2015
Date registered
25/06/2015
Date last updated
27/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of state of (under-)nutrition and its relationship with muscle mass and function over 12 months in institutionalized elderly in South Australia.
Scientific title
Assessment of state of nutrition and its relationship with muscle mass and function over 12 months in institutionalized elderly in South Australia.
Secondary ID [1] 285508 0
Nil Known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Undernutrition 293302 0
Condition category
Condition code
Diet and Nutrition 293575 293575 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
This is an observational study investigating the relationship between nutritional status, muscle mass and function, quality of life, morbidity and mortality in the elderly living in nursing home setting. Measurements will be taken at baseline, 6 months and 12 months.
Intervention code [1] 290446 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293384 0
Nutritional status (e.g: Mini Nutritional Assessment (MNA), Malnutrition Universal Screening Tool (MUST), Malnutrition Screening Tool (MST), Short Nutritional Assessment Questionnaire (SNAQ), Simplified Nutrition Assessment Questionnaire (SNAQ), Geriatric Nutrition Risk Index (GNRI), Frailty Questionnaire (FRAIL), Weighed Food Record over 3 days, and history of ‘Dietetic Nutritional Assessment’, ‘Food and Fluid Intake Chart’, and ‘Meals and Drinks Assessment’)
Timepoint [1] 293384 0
Baseline, 6 and 12 months
Primary outcome [2] 293385 0
Muscle mass (e.g: Body weight, Body mass index, Corrected Arm Muscle Area (CAMA), Skinfold thickness, Mid-arm circumference (MAC), Biceps, triceps and quadriceps muscle diameter with ultrasonography, Fat free mass and lean mass with bio-electrical impedance analysis)
Timepoint [2] 293385 0
Baseline, 6 and 12 months
Primary outcome [3] 293386 0
Muscle function (e.g: Hand dynamometer grip strength, Physical Activity Scale for the Elderly (PASE) and Short Physical Performance Battery (SPPB) including: Gait speed (m/s), 3 meter walk test, Repeated chair stands, Standing balance Semi-tandem / Side-by-side or Tandem, Static balance)
Timepoint [3] 293386 0
Baseline, 6 and 12 months
Secondary outcome [1] 311316 0
Hospital admission(s) (number and length of stay) from patient medical records
Timepoint [1] 311316 0
Baseline, 6 and 12 months
Secondary outcome [2] 315414 0
Level of care from patient medical records
Timepoint [2] 315414 0
Baseline, 6 and 12 months
Secondary outcome [3] 315415 0
Self-health rating questionnaire
Timepoint [3] 315415 0
Baseline, 6 and 12 months
Secondary outcome [4] 315416 0
Use of medications/supplements from patient medical records
Timepoint [4] 315416 0
Baseline, 6 and 12 months
Secondary outcome [5] 315417 0
Blood pressure (systolic/diastolic) and heart rate by sphygmomanometer
Timepoint [5] 315417 0
Baseline, 6 and 12 months
Secondary outcome [6] 315418 0
Blood count and biochemistry screen (e.g CRP, interleukin-1 and -6) by serum assay
Timepoint [6] 315418 0
Baseline, 6 and 12 months
Secondary outcome [7] 315419 0
Quality of life (e.g : Assessment of Quality of Life (AQoL), Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Pittsburg Sleep Quality Index (PSQI), Mini Mental State Examination scale (MMSE), 15-Item Geriatric Depression Scale (GDS), Three Factor Eating Questionnaire (TFEQ), Duke Social Support Index (DSSI), Saint Louis University Mental Status examination (SLUMS))
Timepoint [7] 315419 0
Baseline, 6 and 12 months
Secondary outcome [8] 315420 0
Mortality from patient medical records
Timepoint [8] 315420 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
= > 65 years old living in a nursing home setting
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to comprehend the study protocol

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Relationships between the outcomes will be evaluated using regression analysis. The number of participants required for this study is based on power calculations for the expected changes in nutritional status, muscle mass and functions. Hence, the target sample size is 200, with 15% expected dropout rate.

With 90% power and sample size of 170, the study will be able to detect correlations of 0.25 and above. For multiple linear regression analysis, a ratio of 15:1 for sample size to model degrees of freedom is recommended to ensure stability of the final model. Thus, 170 samples would allow for approximately 11 parameters in the model, allowing for control of baseline variables such as age, gender, cognitive impairment, functioning, co-morbidities and level of care.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2014
Actual
13/05/2015
Date of last participant enrolment
Anticipated
1/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 290103 0
University
Name [1] 290103 0
NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide
Country [1] 290103 0
Australia
Primary sponsor type
Individual
Name
Stijn Soenen , DR
Address
NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health,
Discipline of Medicine, University of Adelaide
Eleanor Harrald Building, Level 6, Frome Road, Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 288810 0
Individual
Name [1] 288810 0
Prof Ian Chapman
Address [1] 288810 0
NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health,
Discipline of Medicine, University of Adelaide
Eleanor Harrald Building, Level 6, Frome Road, Adelaide, SA 5005
Country [1] 288810 0
Australia
Secondary sponsor category [2] 288811 0
Individual
Name [2] 288811 0
Natalie Luscombe-Marsh , DR
Address [2] 288811 0
CSIRO Animal, Food and Health Sciences
SHAMRI Building, North Terrace, Adelaide, SA 5001
Country [2] 288811 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291811 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 291811 0
Level 3, Hanson Institute, IMVS Building
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 291811 0
Australia
Date submitted for ethics approval [1] 291811 0
Approval date [1] 291811 0
26/09/2014
Ethics approval number [1] 291811 0
HREC/14/RAH/189

Summary
Brief summary
This is an observational study which aims to evaluate the nutritional status, muscle mass and function, quality of life, morbidity and mortality in the elderly living in nursing home setting.
Measurements will be taken at baseline, 6 months and 12 months. Outcome measured in this study include: nutritional status, muscle mass and function, hospital admission (number and length of hospital stay), level of care quality of life, and mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52138 0
Dr Stijn Soenen
Address 52138 0
Discipline of Medicine, University of Adelaide
Eleanor Harrald Building, Level 6, Frome Road, Adelaide SA 5005
Country 52138 0
Australia
Phone 52138 0
+61 8 8313 36388
Fax 52138 0
+61 8 8223 3870
Email 52138 0
[email protected]
Contact person for public queries
Name 52139 0
Mr Tony Arjuna
Address 52139 0
Discipline of Medicine, University of Adelaide
Eleanor Harrald Building, Level 6, Frome Road, Adelaide SA 5005
Country 52139 0
Australia
Phone 52139 0
+61 8 8222 5973
Fax 52139 0
+61 8 82233870
Email 52139 0
[email protected]
Contact person for scientific queries
Name 52140 0
Dr Stijn Soenen
Address 52140 0
Discipline of Medicine, University of Adelaide
Eleanor Harrald Building, Level 6, Frome Road, Adelaide SA 5005
Country 52140 0
Australia
Phone 52140 0
+61 8 8313 3638
Fax 52140 0
+61 8 8223 3870
Email 52140 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

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