Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001589178
Ethics application status
Approved
Date submitted
28/10/2019
Date registered
19/11/2019
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The SyNApTIC Study – SarcopeNia, frAilTy, and malnutrition in geriatrIC rehabilitation
Scientific title
The SyNApTIC Study – SarcopeNia, frAilTy, and malnutrition in geriatrIC rehabilitation
Secondary ID [1] 299496 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SyNApTIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 314741 0
Frailty 314742 0
Malnutrition 314740 0
Condition category
Condition code
Diet and Nutrition 313072 313072 0 0
Other diet and nutrition disorders
Physical Medicine / Rehabilitation 313073 313073 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Geriatric patients undergoing inpatient rehabilitation will be assessed for malnutrition, sarcopenia, frailty, functional independence, and quality of life at admission to the rehabilitation ward. Patients will be required to consent to access medical records, complete a questionnaire, physical examinations, and interviews. The questionnaire, physical examinations, and interviews will take approximately 1 hour. These measures will be assessed again at discharge, and data on other patient-centred outcomes (rehabilitation length of stay, pressure ulcers, falls, infections, and mortality) will also be obtained from medical records. At 1-month post-discharge, data on quality of life, readmissions, pressure ulcers, falls, infections, and mortality will be collected.
Intervention code [1] 315753 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321907 0
Prevalence of the syndromes malnutrition, sarcopenia, and frailty
Timepoint [1] 321907 0
Admission and discharge
Secondary outcome [1] 375604 0
Falls by accessing patient's medical records
Timepoint [1] 375604 0
Discharge (falls during admission) and 1-month post-discharge (falls between discharge and 1-month post discharge)
Secondary outcome [2] 375602 0
Rehospitalisation by accessing the patient's medical records
Timepoint [2] 375602 0
Discharge and 1-month post-discharge
Secondary outcome [3] 375599 0
Functional independence measure (FIM) score
Timepoint [3] 375599 0
Admission and discharge
Secondary outcome [4] 375600 0
Rehabilitation length of stay by accessing the patient's medical records
Timepoint [4] 375600 0
Discharge
Secondary outcome [5] 375606 0
In-rehabilitation mortality
Timepoint [5] 375606 0
Discharge
Secondary outcome [6] 375605 0
Infections by accessing the patient's medical records
Timepoint [6] 375605 0
Discharge (infections during admission) and 1-month post-discharge (infections between discharge and 1-month post discharge)
Secondary outcome [7] 375607 0
Mortality
Timepoint [7] 375607 0
1-month post-discharge
Secondary outcome [8] 375601 0
Aged care admission by accessing the patient's medical records
Timepoint [8] 375601 0
Discharge and 1-month post-discharge
Secondary outcome [9] 375603 0
Pressure ulcers by accessing the patient's medical records
Timepoint [9] 375603 0
Discharge (pressure ulcers during admission) and 1-month post-discharge (pressure ulcers between discharge and 1-month post discharge)
Secondary outcome [10] 376733 0
Quality of Life using EQ-5D-5L
Timepoint [10] 376733 0
Admission, discharge, and 1-month post-discharge

Eligibility
Key inclusion criteria
Adults 65 years or older, admitted to Robina Rehabilitation between 1 September 2019 and 31 January 2020 for <72 hours.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment or unable to provide consent (as assessed by the Senior Geriatrician Consultant or medical doctor). Assessment is contraindicated (too unwell etc.) as assessed by health care professional or the researcher. Patient is non-English speaking and a translator is unavailable.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size was calculated to reflect the primary predictive outcome of quality of life as determined by the Assessment of Quality of Life (AQoL-6D). Based on previously published data, the estimated effect size is a score of 5 points (scale 0 to 30) with a standard deviation of 6. Therefore, with 90% power and type I error of 1%, the target sample size is 170 patients, accounting for 40% attrition and 15% for multivariable modelling.
A 3 by 3 contingency table and kappa statistic will be generated to test the sensitivity, specificity, positive and negative predictive values (all with 95%CI) of each assessment method to determine the level of overlap.
T-tests and chi-square tests will be used to test differences between subgroups. Multivariate linear regression or multivariate binomial logistic regression will be used to test the predictive validity of each diagnostic test depending on whether the dependent variables are continuous or dichotomous. Variables will be added to the model to control for confounding by age, gender and any other relevant confounders. As part of the diagnostic accuracy, responsiveness to change will be evaluated by comparing the result of baseline against discharge malnutrition, sarcopenia, and frailty assessments using t-tests and chi-square tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2019
Actual
Date of last participant enrolment
Anticipated
22/02/2021
Actual
Date of last data collection
Anticipated
19/04/2021
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14937 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 28207 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 303995 0
University
Name [1] 303995 0
Bond University
Country [1] 303995 0
Australia
Funding source category [2] 304168 0
Hospital
Name [2] 304168 0
Robina Hospital
Country [2] 304168 0
Australia
Primary sponsor type
University
Name
Bond University
Country
Australia
Secondary sponsor category [1] 304221 0
None
Name [1] 304221 0
Country [1] 304221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304488 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 304488 0
Ethics committee country [1] 304488 0
Australia
Date submitted for ethics approval [1] 304488 0
01/10/2019
Approval date [1] 304488 0
21/10/2019
Ethics approval number [1] 304488 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 97122 0
Dr Barbara van der Meij
Address 97122 0
Bond Institute of Health and Sport 2 Promethean Way, Robina, Queensland, 4226
Country 97122 0
Australia
Phone 97122 0
+61 0413835739
Fax 97122 0
Email 97122 0
bvanderm@bond.edu.au
Contact person for public queries
Name 97123 0
Barbara van der Meij
Address 97123 0
Bond Institute of Health and Sport 2 Promethean Way, Robina, Queensland, 4226
Country 97123 0
Australia
Phone 97123 0
+61 0413835739
Fax 97123 0
Email 97123 0
bvanderm@bond.edu.au
Contact person for scientific queries
Name 97124 0
Barbara van der Meij
Address 97124 0
Bond Institute of Health and Sport 2 Promethean Way, Robina, Queensland, 4226
Country 97124 0
Australia
Phone 97124 0
+61 0413835739
Fax 97124 0
Email 97124 0
bvanderm@bond.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case

Conditions for requesting access:
• -

What individual participant data might be shared?
• Descriptive variable data (gender, age, etc.), and main outcomes such as frailty, malnutrition, and sarcopenia scores, all deidentified.

What types of analyses could be done with individual participant data?
• Meta-analyses, and studies with similar or the same aim to ours.

When can requests for individual participant data be made (start and end dates)?
From:
Start 1 month from the publication date and end 5 years from publication date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By emailing the Principal Investigator Dr Barbara van der Meij at bvanderm@bond.edu.au or Dr Skye Marshall at smarshal@bond.edu.au

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  bvanderm@bond.edu.au
Statistical analysis plan  bvanderm@bond.edu.au


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.