Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000518763
Ethics application status
Approved
Date submitted
17/04/2013
Date registered
9/05/2013
Date last updated
11/02/2019
Date data sharing statement initially provided
11/02/2019
Date results provided
11/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The MARRC Study: Malnutrition in the Australian Rural Rehabilitation Community
Scientific title
Malnutrition in the Australian rural rehabilitation community: a prospective observational study observing usual care in older adults admitted for rehabilitation
Secondary ID [1] 282357 0
Nil
Universal Trial Number (UTN)
U1111-1142-0567
Trial acronym
The MARRC Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 288923 0
Condition category
Condition code
Diet and Nutrition 289268 289268 0 0
Other diet and nutrition disorders
Physical Medicine / Rehabilitation 289284 289284 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
12
Target follow-up type
Weeks
Description of intervention(s) / exposure
Usual care was observed as provided to older adults admitted to rehabilitation units with pre-existing protein-energy malnutrition, with follow-up 3-months post-discharge. The level of allied health intervention during and post-rehabilitation was observed and reported to describe the usual care.
Intervention code [1] 286980 0
Treatment: Other
Intervention code [2] 286981 0
Rehabilitation
Intervention code [3] 286982 0
Lifestyle
Comparator / control treatment
Once enrolled and baseline data collection is performed, the participants will be placed on a high energy and high protein diet which includes one 1kcal/ml oral nutrition supplement per day. The high energy high protein diet alters the menu choices for an inpatient to eliminate energy and protein poor options. Participants will only receive individualised medical nutrition therapy by the rehabilitation dietitian if referred by the rehabilitation team as part of usual care. The participant will receive inpatient follow-up and intervention within the time and resource restraints typical to a rural rehabilitation unit in NSW, however will not receive any post-discharge follow-up from the rehabilitation dietitian. The intervention delivered by the rehabilitation dietitian will not typically involve informal carers, but may involve community dietitian referrals and registration for discounted oral nutrition supplements (ONS) once the participant is discharged. Follow-up for older adults once discharged is minimal due to resource restraints and high waiting times for community consultations. The rehabilitation dietitian is not a study investigator and their involvement with study participants will be monitored by the primary researcher in the medical notes.
Control group
Active

Outcomes
Primary outcome [1] 289372 0
Nutrition status measured by the scored patient generated subjective global assessment (PGSGA)
Timepoint [1] 289372 0
Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)
Secondary outcome [1] 302358 0
Physical Function measured by the Modified Barthel Index
Timepoint [1] 302358 0
Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)
Secondary outcome [2] 302359 0
Quality of Life measured by the SF-36 (Acute, V2)
Timepoint [2] 302359 0
Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)
Secondary outcome [3] 302360 0
Length of Stay
Timepoint [3] 302360 0
Discharge from rehabilitation (Discharge assessment)
Secondary outcome [4] 302361 0
Nutrition status measured by the Mini Nutritional Assessment (MNA)
Timepoint [4] 302361 0
Admission to rehabilitation (Baseline assessment), 3 weeks post-admission Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)
Secondary outcome [5] 302362 0
Weight (Kg) measured using calibrated digital bioimpedance scales
Timepoint [5] 302362 0
Admission to rehabilitation (Baseline assessment), 3 weeks post-admission Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)
Secondary outcome [6] 302363 0
Participant satisfaction measured using a patient satisfaction survey of inpatient clinical nutrition services developed by Ferguson et al. (2001)
Timepoint [6] 302363 0
90 days post-discharge (Outcome assessment)
Secondary outcome [7] 302364 0
Acute care or emergency admissions post-discharge
Timepoint [7] 302364 0
90 days post-discharge (Outcome assessment)
Secondary outcome [8] 302365 0
Discharge location
Timepoint [8] 302365 0
Discharge from rehabilitation (Discharge assessment)
Secondary outcome [9] 303797 0
Institutionalisation (ie admission to a nursing home or aged care facility, Y/N) once already discharged. Measured via self-report.
Timepoint [9] 303797 0
90 days post discharge assessment
Secondary outcome [10] 303798 0
Cost-effectiveness - calculated using QALYs derived from the AQoL-6D assessment
Timepoint [10] 303798 0
90 days post discharge

Eligibility
Key inclusion criteria
Study centres were chosen by convenience sampling based on location. Patients greater than or equal to 65 years admitted to the participating rehabilitation units with a patient-generated subjective global assessment (PG-SGA) rating of B (mild-moderate malnutrition) or C (severe malnutrition), if they were community-dwelling residents prior to admission with the view they would be discharged back to the community and they have an acknowledged informal carer. This includes community-dwelling patients transferred from acute care. An informal carer for this study was considered an adult family member or close friend who a) lives with the older adult or b) does not live with the adult but provides care to the older adult for four days or more each week. The details of the carer will be provided by the participant in the first instance and reaffirmed by the informal carer.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Well nourished (PG-SGA rating A) patients are excluded. If it becomes apparent that a participant will have their discharge location changed from the community to a residential aged care facility, they will be included with an intention-to-treat approach however will not receive final outcome assessments. Informal carers will be invited to participate in the study in order to complete secondary outcome measures; however their non-participation does not excluded eligible older adults from participating in the study.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Sample size: The scored patient generated subjective global assessment (PG-SGA), the primary outcome measure, was considered as a continuous variable with an expected standard deviation in the control group of 6.0. Assuming that the minimum difference of interest across comparison groups is 4, then 48 subjects per group will be required to detect this difference with 90% power and type I error of 5% or less (two-tailed). Assuming an attrition rate of 30% over 90 days, and allowing 15% extra for the application multivariable modelling techniques to adjust for confounding, 96 x 1.3 x 1.15 = 144 subjects need to be approached to retain 110 subjects by the end of the study.
The results will be analysed with an intention to treat approach. Potentially confounding variables to be included in multivariate models include: age (continuous), gender (dichotomous), polypharmacy (Y/N; dichotomous), education level (secondary/tertiary/trade; categorical) and the modified mini-mental state score (continuous). Any confounding variables found to correlate strongly will be combined for use in multivariate models. Descriptive statistics (mean +/- standard deviation, median and interquartile range) will be used to characterise potentially confounding variables not included in multivariate models, the sample population, non-participants, lost-to-follow-up, and to report process evaluation. Normality will be assessed using the Shapiro-Wilk test and homogeneity of variance using a scatterplot. If data is skewed, log transformations and parametric tests will be applied. If the data is unable to be transformed to improve the distribution, the appropriate non-parametric tests will be used.
Outcomes will be compared at three time-points (T1, T2, T3) for nutrition status and, weight. Quality of life and physical function will be compared at discharge and 90 days post-discharge (T2 and T3). One-off measures will be compared between groups at that time point only, for example length of stay (T3).
The Chi-squared test and analysis of variance (ANOVA) will be used to compare categorical and continuous data per group allocation (control and intervention) at each relevant time-point. Nutrition status and weight will also be assessed for within-subject changes over time using mixed linear models. Logistic regression will be used to calculate relative risk ratios for categorical dependent variables (MBI category, discharge location, hospitalisation and institutionalisation post-discharge) and multiple linear regression will be used to assess continuous dependent variables (scored PG-SGA, MNA, weight, AQoL-6D score, length of stay and hospital admissions) for comparison between groups (intervention and control).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2013
Actual
2/08/2012
Date of last participant enrolment
Anticipated
Actual
1/02/2014
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
90
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287124 0
Self funded/Unfunded
Name [1] 287124 0
Country [1] 287124 0
Primary sponsor type
Individual
Name
Skye Marshall
Address
Institute of Health and Sport, Bond University, Robina, Queensland, 4229
Country
Australia
Secondary sponsor category [1] 285897 0
University
Name [1] 285897 0
Bond University
Address [1] 285897 0
Institute of Health and Sport, Bond University, Robina, Queensland, 4229
Country [1] 285897 0
Australia
Other collaborator category [1] 277365 0
Government body
Name [1] 277365 0
Northern NSW Local Health District
Address [1] 277365 0
PO Box 821, Murwillumbah 2484 NSW
Country [1] 277365 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289131 0
North Coast New South Wales Human Research Ethics Committee
Ethics committee address [1] 289131 0
Ethics committee country [1] 289131 0
Australia
Date submitted for ethics approval [1] 289131 0
11/04/2013
Approval date [1] 289131 0
09/05/2013
Ethics approval number [1] 289131 0
North Coast New South Wales Human Research Ethics Approval: LNR 063
Ethics committee name [2] 289693 0
University of Queensland School of Human Movement Studies Ethics Committee
Ethics committee address [2] 289693 0
Ethics committee country [2] 289693 0
Australia
Date submitted for ethics approval [2] 289693 0
25/06/2013
Approval date [2] 289693 0
30/07/2013
Ethics approval number [2] 289693 0
HMS13/0731

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39374 0
Ms Skye Marshall
Address 39374 0
Institute of Health and Sport, Bond University, Robina, Queensland, 4229
Country 39374 0
Australia
Phone 39374 0
+61 411166230
Fax 39374 0
Email 39374 0
[email protected]
Contact person for public queries
Name 39375 0
Skye Marshall
Address 39375 0
Institute of Health and Sport, Bond University, Robina, Queensland, 4229
Country 39375 0
Australia
Phone 39375 0
+61 411166230
Fax 39375 0
Email 39375 0
[email protected]
Contact person for scientific queries
Name 39376 0
Skye Marshall
Address 39376 0
Institute of Health and Sport, Bond University, Robina, Queensland, 4229
Country 39376 0
Australia
Phone 39376 0
+61 411166230
Fax 39376 0
Email 39376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not ethically approved to publish or make available individual data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Malnourished older adults admitted to rehabilitati... [More Details]

Documents added automatically
No additional documents have been identified.