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Trial registered on ANZCTR


Registration number
ACTRN12618000338268
Ethics application status
Approved
Date submitted
28/02/2018
Date registered
6/03/2018
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Date results information initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The FREER Pilot Study (Family in Rehabilitation: EmpowERing carers for improved nutrition outcomes)
Scientific title
Comparison of the FREER intervention with usual care to improve patient nutritional status, physical function, quality of life, service satisfaction, and hospital and aged care admission rates during rehabilitation admission and up to 3-months post-discharge in malnourished older rehabilitation patients and their adult family carers,
Secondary ID [1] 294182 0
None.
Universal Trial Number (UTN)
None.
Trial acronym
FREER Pilot Study
Linked study record
None.

Health condition
Health condition(s) or problem(s) studied:
Protein-energy malnutrition 306816 0
Condition category
Condition code
Diet and Nutrition 305924 305924 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention approach: By integrating formal and family care for malnourished rehabilitation patients, family carers will be empowered to improve the efficacy of their individualised nutrition support. We have applied the four-step systematic approach for using the theoretical domains framework to develop and establish the feasibility of the FREER intervention strategies. This was done through systematic and narrative (examining qualitative aspects of interventions) reviews, a qualitative study of support needs and preferences, a pilot of intervention acceptability and qualitative impact (n=4 carers; unpublished), and stakeholder engagement (n=20 health care staff; unpublished). This project now proposes to establish the preliminary efficacy of the FREER intervention through a pilot trial. FREER intervention components will be delivered by a Research Assistant (an Accredited Practising Dietitian; herein referred to as the “study dietitian”) and will use three individualised and needs-based strategies. These are:
1. Nutrition counselling during rehabilitation admission: The family carer will be engaged as an essential part of the nutrition care team for the malnourished patient by the study dietitian. The carer will be involved with: patient assessment; one or more collaborative nutrition counselling and education sessions; and discharge planning. Guided by evidenced-based practice guidelines (Watterson et al. 2009) the sessions will be focused on improving patient nutrition status, The frequency and duration of the inpatient sessions is individualised based on need and length of rehabilitation admission. There will be a minimum of 1 session with no maximum number of sessions. It is estimated the initial session will be approximately 30-60 minutes, with follow-up sessions 10 - 30 minutes duration). The first session will take place within one week following admission, and the last session within one week of discharge (if patient discharge is planned within one week of the first session, there will be only one session acting as both initial intervention and discharge intervention).
Nutrition counselling will provide a nutrition care plan which provides highly individualised nutrition support strategies used to treat malnutrition, which are usually targeted towards enabling the care-recipient to consume appropriate high protein-high energy foods. Counselling will also involve recommendations of strategies and resources that assist in overcoming the individual’s nutrition-related barriers (e.g. low appetite, food aversions, fatigue, poor dentition). The nutrition care plan will utilise a food-first approach; however, oral nutritional supplements may be provided if patients are unable to consume sufficient protein and energy by food alone. The intervention will be delivered by standard menu changes and additions via the rehabilitation food service as well as foods/beverages brought in by carers. Carers will also be linked to other existing rehabilitation services as needed, such as speech pathology for modified food textures, or occupational therapy for modified eating utensils. Carer engagement strategies will apply the theory of planned behaviour to increase an individual’s ability to make recommended changes through goal setting, problem solving and contingency planning.
Ideally, the carer will attend the rehabilitation site to participate in the collaborative nutrition counselling; whereby paper-based resources will be provided. However, if the carer is not able to attend the facility at the required time, they will be engaged via telephone and the resources will be a) left at the patient bedside for them to collect at next visit, b) mailed to them by post, or c) emailed, according to carer preference.
Any referrals made to other health staff during rehabilitation admission will be made via the existing electronic referral system. Referrals to services or professionals outside of the rehabilitation site will be made according to the existing referral system.
All intervention, referrals and contacts will be recorded in patients’ electronic medical records by the study dietitian. Adherence to the intervention will be monitored through food service records (consumption/acceptance of supplements and/or specially ordered foods and 24 hour recall).
2. Telehealth follow-up: The patient and family carer will receive a minimum of four 15-30min telephone consultations from the study dietitian focussed on patient nutrition support for a period of 12-weeks post-discharge from rehabilitation. Consultations will be as needed, but will be at least every three weeks. These telehealth consultations will either a) involve both the patient and carer, or b) be provided separately if patient and carer cannot attend the call together (patient consulted first). Consultations will be individualised, follow a semi-structured plan, and apply the theory of planned behaviour. Consultation content will be centred around nutritional monitoring, food and nutrition-related problem-solving, modification of the individualised nutrition care plan for the patient, and linking with further supportive services such as home-delivered meals, provision of oral nutritional supplements, or referral to other allied health professionals. Adherence to intervention will also be monitored through 24-hour recall.
3. Resources: A resource pack will be provided to and discussed with, family carers to support their day-to-day caregiving (during and following rehabilitation) and for reference to topics discussed during telehealth follow-up consultations. This pack will include written educational material on appropriate foods and hydration for older adults with malnutrition. Items included will be: 1) High Protein High Energy Diet (NEMO* Resources), which includes a weight monitoring calendar, 2) Individually written meal plans/goals using the FREER Meal Plan & Recommendations form. Additional NEMO Resources from the NEMO website will be selected to suit the individual patient’s needs. The meal plan & recommendations form will be updated for each dietetic consultation, and additional resources provided as needed. Any additional resources required during telehealth sessions will be mailed to the participant and carer following the telehealth appointment.
*Nutrition Education Materials Online (NEMO) is a website with nutrition resources suitable for use by clinical dietitians, coordinated by the Royal Brisbane & Women’s Hospital, with contributions from dietitians across Australia. It includes a range of resources for various conditions including malnutrition and dysphasia which are unaltered to ensure consistency, and have undergone a process of quality assurance. They are available freely from health.qld.gov.au/nutrition.
Oral nutritional supplements: Supplements will be provided to participants on a case-by-case basis. If they are provided during the rehabilitation admission this will be via standard procedures whereby supplements are ordered as part of the food service. The supplements chosen will be subject to food service stock availability and participant preference. Upon discharge, if supplements are recommended for an individual to consume at home or during an aged care admission, they will be provided by the study researchers using products supplied in-kind. The type, flavour, and dose will vary according to individual needs and availability. If participants require a new supplement to commence once they are discharged, it will need to be collected from the rehabilitation site. Once the study has concluded, if patients require ongoing nutrition support and ongoing supplements, they will be referred to the Murwillumbah community dietitian to access dietetic outpatient services and discounted supplements.
Intervention code [1] 300476 0
Treatment: Other
Comparator / control treatment
Participants in a prospective observational study recruited from two sites, recruited in 2013-2014 will act as a historical control group. They had a mean age of 80 years and 57% were female. This group received usual care, which included being placed on a standard high protein-high energy diet during admission and receiving standard nutrition support from the existing rehabilitation dietitian if referred by the usual clinical pathways. Although the service was available, no participants in the control group received outpatient follow-up by a community dietitian. Family carers of patients in the control group were not engaged specifically, but may have been involved in some discussions with the rehabilitation dietitian during their care-recipient’s admission.
Control group
Historical

Outcomes
Primary outcome [1] 304957 0
Nutrition status according to the PG-SGA
Timepoint [1] 304957 0
12-weeks post-discharge
Secondary outcome [1] 343727 0
Body weight (kg; digital scale)
Timepoint [1] 343727 0
12-weeks post-discharge
Secondary outcome [2] 343728 0
Energy intake (kJ; assessed by 24-hour recall)
Timepoint [2] 343728 0
12-weeks post-discharge
Secondary outcome [3] 343729 0
Protein intake (g; assessed by 24-hour recall)
Timepoint [3] 343729 0
12-weeks post-discharge
Secondary outcome [4] 343730 0
Mid arm muscle circumference (cm)
Timepoint [4] 343730 0
12-weeks post-discharge
Secondary outcome [5] 343731 0
Physical function (Modified Barthel Index)
Timepoint [5] 343731 0
12-weeks post-discharge
Secondary outcome [6] 343732 0
Health related quality of life (AQoL-6D)
Timepoint [6] 343732 0
12-weeks post-discharge
Secondary outcome [7] 343733 0
Patient service satisfaction (study-specific questionnaire)
Timepoint [7] 343733 0
12-weeks post-discharge
Secondary outcome [8] 343734 0
Rehabilitation length of stay (Length of stay calculated from day of admission to day of discharge)
Timepoint [8] 343734 0
Discharge
Secondary outcome [9] 343735 0
Residential aged care admission (Yes/No; informed by medical record and/or patient or carer interview)
Timepoint [9] 343735 0
12-weeks post-discharge
Secondary outcome [10] 343736 0
Carer burden (Zarit Burden Score)
Timepoint [10] 343736 0
12-weeks post-discharge
Secondary outcome [11] 343812 0
Carer service satisfaction (study-specific questionnaire)
Timepoint [11] 343812 0
12-weeks post-discharge

Eligibility
Key inclusion criteria
• Older adults (65years or older) admitted to rehabilitation with malnutrition diagnosed by the Patient Generated Subjective Global Assessment (PG-SGA)
• Having a family carer (18 years or older). Family carers will be considered persons (including family, friends, and neighbours) who were assisting with activities of daily living up until the point of hospital admission, with no financial reimbursement beyond a carer’s pension, with a point of contact with the patient of 4 or more times per week either in person or by telephone.
• Family carer is English-speaking and able to act as translator for the patient if the patient is non-English speaking.
• Family carers do not have any health-related eligibility criteria applied; however, will need to have sufficient independence to provide the required care to meet inclusion criteria.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient and/or carer are unable to give consent.
• Patients are on enteral or parenteral tube feeding,
• Discharge is planned in <6-days from date of screening
• Patients living in residential aged care prior to rehabilitation admission are excluded; however, previously community-dwelling patients discharged to residential aged care will be included following an intention-to-treat approach.
• The patient and/or carer do not live in the local area e.g. admitted during holiday, or plan to move away from local catchment area within 3-months post-discharge

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will be used. Outcomes and participant characteristics will be summarised via descriptive statistics. Changes in the control group over time have been previously analysed and published; however, the intervention group will be analysed for change over time in continuous variables using linear mixed models, and chi-square tests for categorical variables.
To determine the difference in primary and secondary outcomes between the intervention and control group over time, both continuous and categorical outcome variables will be analysed via a marginal model using generalised estimating equations, with study group allocation and time in months as main predictors, and adjusting for baseline outcome measure and minimisation variables.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10228 0
Murwillumbah District Hospital - Murwillumbah
Recruitment postcode(s) [1] 21892 0
2484 - Murwillumbah

Funding & Sponsors
Funding source category [1] 298815 0
University
Name [1] 298815 0
Bond University
Address [1] 298815 0
University Drive, Robina,
4226, Qld
Country [1] 298815 0
Australia
Primary sponsor type
University
Name
Bond University
Address
University Drive, Robina,
4226, Qld
Country
Australia
Secondary sponsor category [1] 298010 0
None
Name [1] 298010 0
Address [1] 298010 0
Country [1] 298010 0
Other collaborator category [1] 279967 0
Government body
Name [1] 279967 0
Northern NSW Local Health District
Address [1] 279967 0
Tweed Heads NSW 2485, Australia
Country [1] 279967 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299763 0
North Coast New South Wales (NCNSW) Human Research Ethics Committee (HREC)
Ethics committee address [1] 299763 0
NCNSW Human Research Ethics Committee
PO Box 821 Murwillumbah NSW 2484
Ethics committee country [1] 299763 0
Australia
Date submitted for ethics approval [1] 299763 0
05/03/2018
Approval date [1] 299763 0
15/05/2018
Ethics approval number [1] 299763 0
Ethics committee name [2] 300904 0
Bond University Human Research Ethics Committee
Ethics committee address [2] 300904 0
Research Services,
Bond University
University Drive
Robina
Queensland 4226
Australia
Ethics committee country [2] 300904 0
Australia
Date submitted for ethics approval [2] 300904 0
07/06/2018
Approval date [2] 300904 0
27/06/2018
Ethics approval number [2] 300904 0
528N-HREC/18/NCC/47

Summary
Brief summary
To support healthy ageing, interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas of the United Nations 21st Century Research Agenda (items 2.6.10 and 2.10.7). Our observational pilot research identified that one in two older Australians admitted to rehabilitation in Murwillumbah were malnourished, and that they remained malnourished throughout their admission and for at least 12-weeks in their own homes following discharge. Compared with well-nourished patients, malnourished patients were more likely to be admitted to residential aged care and be rehospitalised. Supported by feasibility studies which utilised the “theoretical domains framework”, the proposed pilot intervention project evaluates efficacy of the FREER (Family in Rehabilitation: EmpowERing carers for improved nutrition outcomes) intervention: a low-cost model of care for malnourished older rehabilitation patients which harnesses the under-utilised expertise/skills of family carers to synergise with the existing nutrition workforce support. Through providing malnutrition counselling in rehabilitation, telehealth follow-up and supportive resources after discharge, FREER aims to cost-effectively empower family carers to improve patient and carer health-related outcomes. Using a historically controlled, two-arm intervention trial design, the FREER Pilot Study aims to determine:
In n=30 malnourished older rehabilitation patients and their adult family carers, does the FREER intervention, compared with usual care, improve a) patient nutritional status, b) physical function, c) quality of life, d) service satisfaction, e) hospital and aged care admission rates during rehabilitation admission and up to 3-months post-discharge? As a pilot study, this project also aims to evaluate the feasibility and intervention fidelity to inform a larger RCT.
The intervention group will be compared with n=30 historical control participants with the same eligibility criteria collected from Ballina and Murwillumbah rehabilitation units from 2013-2014.
Trial website
None.
Trial related presentations / publications
None.
Public notes
None.

Contacts
Principal investigator
Name 81490 0
Dr Skye Marshall
Address 81490 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 81490 0
Australia
Phone 81490 0
+61 7 559 55530
Fax 81490 0
Email 81490 0
skye_marshall@bond.edu.au
Contact person for public queries
Name 81491 0
Dr Skye Marshall
Address 81491 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 81491 0
Australia
Phone 81491 0
+61 7 559 55530
Fax 81491 0
Email 81491 0
skye_marshall@bond.edu.au
Contact person for scientific queries
Name 81492 0
Dr Skye Marshall
Address 81492 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 81492 0
Australia
Phone 81492 0
+61 7 559 55530
Fax 81492 0
Email 81492 0
skye_marshall@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study does not have ethical approval for data sharing.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2384 0
Study protocol
Citation [1] 2384 0
Link [1] 2384 0
Email [1] 2384 0
Other [1] 2384 0
https://www.researchprotocols.org/2019/4/e12647/
The published study protocol includes data collection forms and intervention materials as online supporting documentation.
Attachment [1] 2384 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary