Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001388808
Ethics application status
Approved
Date submitted
13/08/2021
Date registered
14/10/2021
Date last updated
14/10/2021
Date data sharing statement initially provided
14/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutrition and EXercise Telehealth care for Malnourished older adults post-hospital discharge (NEXT-M)
Scientific title
Feasibility of implementing Nutrition and EXercise Telehealth care for Malnourished older adults post-hospital discharge (NEXT-M): a pilot randomised controlled trial
Secondary ID [1] 305031 0
None
Universal Trial Number (UTN)
None
Trial acronym
NEXT-M
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
malnutrition 323200 0
sarcopenia 323201 0
Condition category
Condition code
Diet and Nutrition 320782 320782 0 0
Other diet and nutrition disorders
Musculoskeletal 320784 320784 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The nutrition and exercise intervention will be delivered remotely to participants in their home for 12 weeks. The intervention will be delivered using the pre-existing commercial smartphone platform Physitrack. The system allows for development of customised video clips and text to deliver the exercise and nutrition components of the intervention in this trial. The nutrition content has been developed by the research team for deliver via the Physitrack system; the exercise component will use content already available within this system.

Nutrition video clips focus on increasing energy and protein intake through fortifying pre-existing meals, adding high energy/protein meals, snacks and drinks to meet estimated energy and protein requirements. Clips include education sessions spoken to camera, whilst other content will provide practical food demonstrations (eg. how to prepare fortified milk at home). These will be personalised for each participant, with dietary changes aiming to reach the European Society for Parenteral and Enteral Nutrition requirements (25–30 kcal/kg and 1.5 g/kg ideal body weight). At least 2 personalised nutrition clips will be prescribed based on requirements per participant per week, these will be allocated weekly. The duration of these clips is 5-20minutes and participants will be encouraged to view the allocated clips each week. The nutrition clips include instruction on specific nutrition interventions, eg. How to make high energy high protein milk, why full fat yoghurt is a better choice than “diet” yoghurt, how to fortify meals through adding cheese, milk powder etc. These clips will be personalised for participants through allocation by an Accredited Practising Dietitian. Personalised messages and surveys may be sent through Physitrack to evaluate adherence and engagement.

A 30-minute, home-based exercise program, personalised for each participant by an Accredited Exercise Physiologist, will be delivered by Physitrack as per American College of Sports Medicine (ACSM) guidelines for chronic health conditions. The protocol will deliver two exercise sessions per week for the first four weeks, three session per week for the second four weeks, and four sessions per week for the final four weeks. Exercise clips will focus on strength, balance and aerobic exercises. It is anticipated that for most participants, resistance exercises will be body weight supported. The strength training exercise prescription will involve functional strength training exercises for the upper and lower body (e.g. sit to stand, calf raise, wall push up, step ups) using body weight only. Participants will be prescribed a three set of 10 repetition per exercise set at a moderate intensity of self-perceived exertion using the modified rating of perceived exertion scale scale (RPE) 3-6 on the 10-point modified RPE scale. The balance component involved static and dynamic balance (e.g. standing eyes open, feet together, tandem walking) with one repetitions of each balance exercise prescribed for 30 seconds at moderate intensity (3-6 on the 10-point modified RPE scale).
The aerobic component of the exercise component will involve up to 10 minutes of walking in the community at moderate intensity (3-6 on the 10-point modified RPE scale).
Following each exercise, the Physitrack software will determine whether the participant completed the exercise, their self-perceived exertion and any concerns (e.g. Pain, dizziness).
Participants’ responses to these questions will be recorded and saved to the Phyitrack database, enabling the exercise physiologist to review and modify or progress exercise prescriptions as required.

Ten participants for the qualitative interviews will be chosen at random from the 25 participants in the intervention group. The website https://www.random.org/sequences/ will be used for randomisation. Where any decline, the next participant will be chosen, until 10 interviews are complete. The Braun & Clarke thematic analysis will be used to analyse the data. Through this approach, codes will be grouped and summarised, with thematic maps drawn to realise connections and patterns in the data. Two investigators from the research team will compare content and themes. Any disagreement will be resolved by consensus moderation.
Intervention code [1] 321426 0
Lifestyle
Intervention code [2] 321930 0
Treatment: Other
Comparator / control treatment
Control group participants will receive general content on physical activity and nutrition through traditional education material (paper only) in week 1 of the trial consistent with usual care/discharge practice. If the participants make contact with researchers requesting dietary/exercise advice during this time, they will be asked to consult with their general practitioner or hospital discharge clinicians to receive usual care.
Post completion of the study (12 weeks) we will provide access to the nutrition and exercise videos used for the intervention available to control group participants.
There will be no qualitative interviews with the control group participants.
Control group
Active

Outcomes
Primary outcome [1] 328599 0
Greater or equal to 90% retention in the intervention group determined by proportion of participants who are still engaging with the videos at week 12.
Timepoint [1] 328599 0
At the completion of the 12 week intervention
Primary outcome [2] 328968 0
The proportion of participants that achieve completion rates of greater or equal to 66% of prescribed exercise and dietary intervention determined by participants viewing the intervention videos.
Timepoint [2] 328968 0
At the completion of the 12 week intervention
Primary outcome [3] 328969 0
Recruitment of greater or equal to 20% of eligible participants, that is the proportion of eligible participants that accept to participate in the study.
Timepoint [3] 328969 0
At the completion of the 12 week intervention
Secondary outcome [1] 399596 0
App engagement: assessed by accessing app analytics
Timepoint [1] 399596 0
Assessed weekly for the 12 week intervention period
Secondary outcome [2] 400994 0
Dropout rate: measured as the proportion of people who withdraw (across intervention, control and combined groups) through advising the research team that they wish to withdraw compared with the total number of participants.
Timepoint [2] 400994 0
Assessed at study completion
Secondary outcome [3] 400995 0
Quality of life: (measured using the EQ-5D-5L tool) of each participant
Timepoint [3] 400995 0
Assessed at baseline and at completion of the 12 week intervention
Secondary outcome [4] 400996 0
Participant weight (self reported by participant in kg)
Timepoint [4] 400996 0
At baseline and at completion of the 12 week intervention
Secondary outcome [5] 400997 0
Participant body mass index (using height and weight both self reported by participant)
Timepoint [5] 400997 0
Determined at baseline and at completion of the 12 week intervention
Secondary outcome [6] 400998 0
Recent dietary intake of participants: estimated through collection of a paper based 3 day food record pre- and post- intervention for all participants. Each food record will be analysed in Foodworks (version 10, Xyris Software) to estimate energy and protein intake.
Timepoint [6] 400998 0
Determined at baseline and at completion of the 12 week intervention
Secondary outcome [7] 400999 0
Participant performance in the 30-second sit-to-stand test (for testing lower limb strength and endurance)
Timepoint [7] 400999 0
Determined at baseline and at completion of the 12 week intervention
Secondary outcome [8] 401000 0
System acceptability (qualitative information obtained by a semi-structured interview of approximately 30 minutes using Zoom videoconferencing software). This information will be sought from a random selection of 10 intervention group participants.
Timepoint [8] 401000 0
At completion of the 12 week intervention

Eligibility
Key inclusion criteria
Participants will be community living older adults who are at risk of malnutrition (identified by a malnutrition screening tool (MST) greater than or equal to 3), or are diagnosed in the medical record by Western Health dietitians as being malnourished. They will have received care by a dietitian within the heterogenous range of healthcare services (including subacute, oncology and post-surgery services) offered at Western Health. Participants will not have chronic kidney disease as this may contra-indicate the dietary advice provided.
Participants should be planning to be at home for at least 8 weeks during the enrolment period; able to communicate in English; do not have a cognitive or physical impairment or disability that in the opinion of the participant’s’ GP/specialist and/or study investigators would result in the participant having difficulty interacting with Physitrack or performing unsupervised exercise and dietary intervention safely.
Participants also must answer ‘no’ to all six questions on the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool to ensure that it is safe for them to exercise at moderate exertion.
Participants will have access to home internet.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Discharged greater than 1 month ago
2. Expect to be away for 4 weeks or more during the intervention
3. Has chronic kidney disease
4. Unable to exercise safely in a home environment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The research assistant responsible for recruitment and baseline/endpoint measures will remain blinded to the group allocation throughout the study duration. Randomisation will occur post baseline data collection. Participants will be randomised using random, opaque envelopes by an academic staff member of School of Exercise and Nutrition Sciences at Deakin University that is independent to the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization, with random blocks of sizes 2 and 4, will be used to maintain the balance across treatment groups. We will stratify randomisation by sex to maximise allocation balance across the sexes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of quantitative data:
For primary outcomes related to feasibility, study retention (greater than or equal to 90%); frequency of accessing Physitrack; and completing greater than or equal to 66% of prescribed exercise and nutritional intervention will be reported. Provided parametric assumptions are met, independent-samples t-tests would be used to examine between-arm differences in pre-post change. Where assumptions are not met, non-parametric Wilcoxon ranked sum tests would be used. For all analyses, a P-value of <0.05 or 95% confidence interval will be considered statistically significant.

All nutritional data will be analysed using SPSS Statistics Version 24 (IBM, USA). At the completion of the study, the 3 day food records for each participant will be analysed using FoodWorks (Xyris Software). Macro- and micronutrient data from this analysis, and all other data will be entered into a password protected Microsoft Excel database. Data will be exported to an SPSS file and each variable inspected for data errors. In the case of missing data, original files will be consulted to identify the correct values. When correct values cannot be confirmed, the data point will be classified as missing.

Analysis of qualitative interviews:
A modified thematic framework using the approach of Braun & Clarke (2006) will be used to analyse the qualitative data. Through this approach, codes will be grouped and summarised, with thematic maps drawn to realise connections and patterns in the data. NVivo computer software (version 12, QSR International Pty Ltd, Doncaster, Victoria, Australia) will be used to code, chart and map the data. Five stages of coding will be completed: i) Familiarisation; ii) Identifying a thematic framework; iii) Indexing; iv) Charting; and v) Mapping and Interpretation. An iterative process will then be used to test and retest the thematic framework.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/10/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
31/05/2022
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20525 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 35305 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 309421 0
University
Name [1] 309421 0
Institute of Physical Activity and Nutrition
Country [1] 309421 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood Victoria 3125
Country
Australia
Secondary sponsor category [1] 310392 0
None
Name [1] 310392 0
Address [1] 310392 0
Country [1] 310392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309223 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 309223 0
RMH City Campus, Level 2 South West
300 Grattan Street | Parkville Victoria 3050
Ethics committee country [1] 309223 0
Australia
Date submitted for ethics approval [1] 309223 0
26/05/2021
Approval date [1] 309223 0
28/07/2021
Ethics approval number [1] 309223 0
HREC/75369/MH-2021
Ethics committee name [2] 309458 0
Deakin University HREC
Ethics committee address [2] 309458 0
Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Ethics committee country [2] 309458 0
Australia
Date submitted for ethics approval [2] 309458 0
25/08/2021
Approval date [2] 309458 0
02/09/2021
Ethics approval number [2] 309458 0
2021-322

Summary
Brief summary
This is a pilot randomised controlled trial for recently discharged patients who are malnourished or at risk of malnutrition to receive a combined nutrition and exercise intervention at home. The control group will receive usual care (paper-based patient education materials) whilst the intervention group will receive personalised nutrition and exercise education for a 12 week period delivered by a digital app into their home. The research assistant who conducts baseline and the 12 week assessment will remain blinded to the group allocation. Outcome measures are: recruitment rate, dropout rate, nutrition and exercise adherence, and app engagement.
Ten intervention group participants will also be invited to contribute to an interview at the conclusion of the intervention to obtain qualitative information on the app and intervention acceptability. All interviews (approx. 30mins each interview) will be completed using Zoom teleconference. The interview will be audio-recorded, and transcribed by a professional transcription service.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113398 0
Prof Judi Porter
Address 113398 0
Deakin University, 221 Burwood Highway, Burwood Vic 3125
Country 113398 0
Australia
Phone 113398 0
+61 39246 8625
Fax 113398 0
Email 113398 0
judi.porter@deakin.edu.au
Contact person for public queries
Name 113399 0
Prof Judi Porter
Address 113399 0
Deakin University, 221 Burwood Highway, Burwood Vic 3125
Country 113399 0
Australia
Phone 113399 0
+61 39246 8625
Fax 113399 0
Email 113399 0
judi.porter@deakin.edu.au
Contact person for scientific queries
Name 113400 0
Prof Judi Porter
Address 113400 0
Deakin University, 221 Burwood Highway, Burwood Vic 3125
Country 113400 0
Australia
Phone 113400 0
+61 39246 8625
Fax 113400 0
Email 113400 0
judi.porter@deakin.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 is a feasibility study, no ethics approval has been obtained for sharing participant level data.


What supporting documents are/will be available?

No Supporting Document Provided



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.