ANZCTR - Registration

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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]

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

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

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]

Treatment: Other

Intervention code [2]

Rehabilitation

Intervention code [3]

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]

Nutrition status measured by the scored patient generated subjective global assessment (PGSGA)

Timepoint [1]

Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)

Secondary outcome [1]

Physical Function measured by the Modified Barthel Index

Timepoint [1]

Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)

Secondary outcome [2]

Quality of Life measured by the SF-36 (Acute, V2)

Timepoint [2]

Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)

Secondary outcome [3]

Length of Stay

Timepoint [3]

Discharge from rehabilitation (Discharge assessment)

Secondary outcome [4]

Nutrition status measured by the Mini Nutritional Assessment (MNA)

Timepoint [4]

Admission to rehabilitation (Baseline assessment), 3 weeks post-admission Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)

Secondary outcome [5]

Weight (Kg) measured using calibrated digital bioimpedance scales

Timepoint [5]

Admission to rehabilitation (Baseline assessment), 3 weeks post-admission Discharge from rehabilitation (Discharge assessment), 90 days post-discharge (Outcome assessment)

Secondary outcome [6]

Participant satisfaction measured using a patient satisfaction survey of inpatient clinical nutrition services developed by Ferguson et al. (2001)

Timepoint [6]

90 days post-discharge (Outcome assessment)

Secondary outcome [7]

Acute care or emergency admissions post-discharge

Timepoint [7]

90 days post-discharge (Outcome assessment)

Secondary outcome [8]

Discharge location

Timepoint [8]

Discharge from rehabilitation (Discharge assessment)

Secondary outcome [9]

Institutionalisation (ie admission to a nursing home or aged care facility, Y/N) once already discharged. Measured via self-report.

Timepoint [9]

90 days post discharge assessment

Secondary outcome [10]

Cost-effectiveness - calculated using QALYs derived from the AQoL-6D assessment

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Skye Marshall

Address

Institute of Health and Sport, Bond University, Robina, Queensland, 4229

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Bond University

Address [1]

Institute of Health and Sport, Bond University, Robina, Queensland, 4229

Country [1]

Australia

Other collaborator category [1]

Government body

Name [1]

Northern NSW Local Health District

Address [1]

PO Box 821, Murwillumbah 2484 NSW

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North Coast New South Wales Human Research Ethics Committee

Ethics committee address [1]

PO Box 821, Murwillumbah 2484
NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/04/2013

Approval date [1]

09/05/2013

Ethics approval number [1]

North Coast New South Wales Human Research Ethics Approval: LNR 063

Ethics committee name [2]

University of Queensland School of Human Movement Studies Ethics Committee

Ethics committee address [2]

School of Human Movement Studies, Connell Building, University of Queensland
St Lucia, QLD 4067

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

25/06/2013

Approval date [2]

30/07/2013

Ethics approval number [2]

HMS13/0731

Summary

Brief summary

The MARRC Study aims to address the gaps in current evidence for the prevention and treatment of malnutrition in older adults. The project aims to answer: “Among malnourished older adults admitted to rural rehabilitation units in New South Wales (NSW), Australia, does engaging the informal carer as part of nutrition support improve nutrition status, functional status, quality of life, rehabilitation outcome (length of stay and institutionalisation), incidence of hospitalisation and cost-effectiveness of care at discharge and 90 days post-discharge compared with usual care?”
The intervention involves nutrition intervention, which is a one off counselling session involving the patient and their informal carer and post-discharge telephone reviews for the informal carer. The control group receives standard care, which does not involve the informal carer or post-discharge support.

Trial website

Trial related presentations / publications

Peer-reviewed publications:
Marshall S., Young A., et. al. (2015). “Malnutrition in geriatric rehabilitation: prevalence, patient outcomes and criterion validity of the Scored Patient-Generated Subjective Global Assessment (PG-SGA) and the Mini Nutritional Assessment (MNA)”. Journal of the Academy of Nutrition and Dietetics, In Press. 

Marshall S., Young A. et al. (2015). “Nutrition screening in geriatric rehabilitation: Criterion (concurrent and predictive) validity of the Malnutrition Screening Tool (MST) and the Mini Nutritional Assessment-Short Form (MNA-SF)”. Journal of the Academy of Nutrition and Dietetics, In Press.

Marshall S., Young A., et. al.  (2015) . “Malnourished older adults admitted to rehabilitation in rural New South Wales remain malnourished throughout rehabilitation and once discharged back to the community: a prospective cohort study” Journal of Aging Research and Clinical Practice, In Press.

Marshall, S., J. Bauer, et. al. (2014).  “The consequences of malnutrition following discharge from rehabilitation to the community:  a systematic review of current evidence in older adults”.  Journal of Human Nutrition and Dietetics, 24: 133-141.

Marshall, S., Bauer, J., Capra, S.,Isenring, E. (2013) Are informal carers and community care workers effective in managing malnutrition in the older adult community? A systematic review of current evidence. The Journal of Nutrition, Health and Aging, (DOI) 10.1007/s12603-013-0341-z.

Oral presentations:
Marshall, S., Young, A., et. al. (2015) Criterion validity of nutrition screening and assessment tools in geriatric rehabilitation. Accepted for presentation at the DAA Qld Branch Professional Development event “3 Minutes to Shine” session, Brisbane, July 2015.

Marshall, S., Young, A., et. al. (2015) Malnourished older adults with informal caregivers admitted to rural rehabilitation units remain malnourished during and after rehabilitation: a prospective cohort study of current practice. Accepted for 10 minute oral presentation to be delivered at the International Association of Geriatrics and Gerontology: Oceania Conference in Chiang Mai, Thailand, October 2015.

Marshall, S., Young, A., et. al. (2015) Malnourished older adults with informal caregivers admitted to rural rehabilitation units remain malnourished during and after rehabilitation: a prospective cohort study of current practice. Accepted for table-top presentation to be delivered at the Australian Association of Gerontology’s National Conference in Alice Springs, November, 2015.

Marshall S., Bauer J., et al. (2014). The consequences of malnutrition following discharge from rehabilitation to the community: A systematic review of current evidence in older adults [Abstract]. Nutrition & Dietetics, 71(S1):5. 10 minute oral presentation delivered at the Dietitian Association of Australia’s National Conference in Brisbane, 2014.

Poster presentations:
Marshall S., Young A., et. al. (2015). Malnutrition in geriatric rehabilitation: prevalence, patient outcomes and criterion validity of the Scored Patient-Generated Subjective Global Assessment (PG-SGA) and the Mini Nutritional Assessment (MNA). Upcoming presentation at AuSPEN / GASTRO2015 Conference in Brisbane, 2015.

Marshall S., Young A., et. al. (2015). Nutrition screening in geriatric rehabilitation: Criterion (concurrent and predictive) validity of the Malnutrition Screening Tool (MST) and the Mini Nutritional Assessment-Short Form (MNA-SF) [Abstract]. 
Nutrition & Dietetics, 72(S1):53. Presented at the Dietitian Association of Australia’s National Conference in Perth, 2015.

Marshall S., Bauer J., et al. (2014). Nutrition assessment in geriatric rehabilitation: comparing the Scored Patient-Generated Subjective Global Assessment (PG-SGA) with the Mini Nutritional Assessment (MNA) [Abstract]. Nutrition & Dietetics. 71(S1):52. Presented at the Dietitian Association of Australia’s National Conference in Brisbane, 2014.

"Best of the Best" Presentation at the Dietitians Association of Australia (DAA) 2013 National Conference in Canberra for "Are informal carers and community care workers effective in managing malnutrition in the older adult community? A systematic review of current evidence"

Public notes

Contacts

Principal investigator

Name

Ms Skye Marshall

Address

Institute of Health and Sport, Bond University, Robina, Queensland, 4229

Country

Australia

Phone

+61 411166230

Fax

skye.marshall@student.bond.edu.au

Contact person for public queries

Name

Skye Marshall

Address

Institute of Health and Sport, Bond University, Robina, Queensland, 4229

Country

Australia

Phone

+61 411166230

Fax

skye.marshall@student.bond.edu.au

Contact person for scientific queries

Name

Skye Marshall

Address

Institute of Health and Sport, Bond University, Robina, Queensland, 4229

Country

Australia

Phone

+61 411166230

Fax

skye.marshall@student.bond.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

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Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Malnourished older adults admitted to rehabilitati... [More Details]

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