Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001495819
Ethics application status
Approved
Date submitted
21/09/2021
Date registered
3/11/2021
Date last updated
1/05/2024
Date data sharing statement initially provided
3/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
HealthyRHearts: The effect of personalised nutrition counselling via telehealth on cholesterol in rural adult populations.
Scientific title
HealthyRHearts: The effect of Medical Nutrition Therapy via telehealth on serum cholesterol in rural adult populations.
Secondary ID [1] 305366 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HealthyRHearts (Healthy Rural Hearts)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 323707 0
Condition category
Condition code
Cardiovascular 321239 321239 0 0
Coronary heart disease
Cardiovascular 321240 321240 0 0
Hypertension
Cardiovascular 321241 321241 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 321242 321242 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Why: Nutrition affects many of the risk factors that lead to the development of heart disease

What (materials):
Provided to participants - Participants will be given an online Food Frequency Questionnaire (FFQ) to complete, the Australian Eating Survey - Heart version (AES Heart). The AES Heart provides feedback to the respondent that targets behaviours related to heart disease risk factors. They will also be provided a Personalised Nutrition Questionnaire (PNQ), which aims to assist in identifying behaviours related to dietary intake that may be contributing to their risk factors for heart disease, and mapping this to relevant behaviour change techniques. Pre-existing, freely available resources were mapped to the PNQ for participant use, with others designed from evidence-based literature. Additional instructions will be provided to participants that relate to the collection of self-reported measures.

Provided to study dietitians - A dietetic manual will be provided to the research dietitians delivering the intervention. This manual has been specifically developed for the study. The document details areas such as using the study systems and technology, interpreting the strengths and limitations related to the AES Heart feedback correctly, using the information provided by the PNQ, information regarding what is covered in each of the sessions with the participants and how to use the patient consultation forms that are housed in REDCap (an online data collection and storage system) and communication techniques. It is approximately 30 pages in length. Reading time will vary, according to the dietitian's familiarity with the processes and resources used. Those completely unfamiliar with all processes will need to read the document carefully, whereas others who may be familiar with some processes or technologies may be able to skim some sections and use it for reference only. Dietitians are expected to be competent in performing the tasks documented, and hence knowledge of the contents is necessary. The manual is used in conjunction with training (documented below).

What (procedures):
Provided to participants: In addition to the intervention, participants also receive usual care. Usual care is defined as anything that is consistent with the clinical judgement of the General Practitioner treating the patient, taking into account health conditions and risk factors, and in agreement with their patient. The form of usual care may vary by doctor, patient and health conditions.

Provided to study dietitians: Study dietitians will undertake 8 hours of training, prior to working with research participants. Approximately two hours is to be used to complete pre-training tasks in the dietitian's own time. Four hours is used for group online training. The remaining two hours is used for one-on-one online training and troubleshooting with the trainer.

Pre-training tasks consist of readings about the current evidence for diet and nutrition related to CVD risk factors and behaviour change (see references in OTHER). Tasks also include completion of the AES - Heart and PNQ, to familiarise with these questionnaires. The group training session is online and interactive. It primarily covers how to use the systems for managing clients, the structure of each consultation, behaviour change philosophies and techniques, discussion of current nutrition evidence for CVD, documenting client notes, using and troubleshooting intervention processes and the distribution of relevant resources to the study participants. Immediately prior to the group training, dietitians are provided access to the dietetic manual, for use during the training. One-on-one online training following the group training provides the dietitians an opportunity to practice a consultation in the format required by the study, with immediate feedback from the trainer.

Who: General Practitioners holding the appropriate qualifications to practice general medicine in Australia will provide usual care. The research dietitians will hold tertiary dietetic qualifications and be registered as an Accredited Practising Dietitian (APD) with Dietitians Australia. In addition to having high levels of nutrition knowledge and counselling skills inherent as a APD dietitian, they are also required to be currently practicing in a regional or rural area of Australian (or have practiced in at least part-time capacity the last 12-months) and to demonstrate a sound understanding of rural contexts and the range of influences impacting on rural populations, including social aspects, the food environment and health care availability.

How: Usual care provided by the study participant's General Practitioner can be either face-to-face or via telephone or videoconferencing, dependent on the nature of the care provided, the resources available to the Practice and subject to any travel or health restrictions that might be in place at the time. Individual dietetic consultations are to be delivered remotely via healthdirect, an online videoconferencing system designed for use in primary care. Participant bookings will be made using Halaxy, a secure client booking system. Participant information will be housed in REDCap, web-based application developed by Vanderbilt University to capture data for clinical research.

Where: The trial will be performed in populations categorised as living in Modified Monash Model (MMM) 3-7 regions, within the area serviced by the Central Coast Hunter New England Primary Health Network. GPs deliver their usual care from their Practice. The study dietitians perform consultations from their homes, offices or from the University of Newcastle Department of Rural Health, as per their preferences.

When and how much: GPs deliver usual care in accordance with their professional judgement. Study dietitians will deliver five dietetic consultations, taking a total of 120 minutes. Session 1 will be approximately two weeks after acceptance into the study and will take approximately 30 minutes. Sessions will follow at weeks 4, 6 and 12, and will take approximately 20 minutes each session. The final session will be 30 minutes at 6 months from enrolment. Intervention participants will complete and receive personalised feedback from the AES Heart at baseline, 3, 6 and 12 months.

Tailoring: Tailoring is an inherent part of the dietetic intervention, in that results from the participants will inform behaviour change strategies used and counselling provided. It is expected that there will be natural variation in the scheduling of consultations. It is envisaged that there will be occurrences where the internet will be insufficient for using the healthdirect platform for the consultation, and either the video aspect of the call will not be used, or the consultation will be replaced by telephone.

Modifications: No modifications are planned at this time.

Fidelity: A sample of online dietetic consultations are planned to determine the fidelity of the intervention to the protocol. Random auditing of dietetic notes will also be used for this purpose.

References to pre-training readings:
Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6(1):42.

Schumacher TL, Burrows TL, Neubeck L, Redfern J, Callister R, Collins CE. How dietary evidence for the prevention and treatment of CVD is translated into practice in those with or at high risk of CVD: a systematic review. Public Health Nutr. 2017;20(1):30-45.

Collins C, Burrows T, Rollo M. Dietary patterns and cardiovascular disease outcomes: An evidence check rapid review brokered by the sax institute (www. Saxinstitute. Org. Au) for the national heart foundation of australia. Accessed June. 2017;5.
Intervention code [1] 321775 0
Treatment: Other
Intervention code [2] 321776 0
Lifestyle
Intervention code [3] 321777 0
Behaviour
Comparator / control treatment
Active - Control group will receive usual care from their GP, as per the intervention group. They will also complete and receive feedback from the AES Heart at baseline, 3, 6 and 12 months. Additional instructions will be provided to control participants that relate to the collection of self-reported measures.
Control group
Active

Outcomes
Primary outcome [1] 329026 0
Total serum cholesterol, collected and analysed by accredited pathology services
Timepoint [1] 329026 0
Baseline, 3, 6 and 12 (primary outcome) months after randomisation.
Primary outcome [2] 329027 0
Serum low density lipoprotein (LDL) cholesterol, collected and analysed at accredited pathology services.
Timepoint [2] 329027 0
Baseline, 3, 6 and 12 months (primary outcome) after randomisation
Primary outcome [3] 329264 0
Serum triglycerides, collected and analysed at accredited pathology services.
Timepoint [3] 329264 0
Baseline, 3, 6 and 12 (primary outcome) months after randomisation
Secondary outcome [1] 401200 0
Systolic and diastolic blood pressure. This will be measured by the General Practitioner, or their appropriate staff, at their service in accordance with their usual routine, and using practices and equipment consistent with their usual care. Values used are those documented in their case files.
Timepoint [1] 401200 0
Baseline and at 12 months after randomisation.
Secondary outcome [2] 401201 0
Percentage of energy from dietary intake attributed to energy-dense, nutrient poor foods. This is measured by the Australian Eating Survey - Heart version.
Timepoint [2] 401201 0
Baseline, and at 3, 6 and 12 months after randomisation
Secondary outcome [3] 401202 0
Self-reported weight
Timepoint [3] 401202 0
Baseline, and at 3, 6 and 12 months after randomisation
Secondary outcome [4] 401203 0
Quality of life, as assessed by the PROMIS Global Health Scale (v1.2, 13th April, 2018)
Timepoint [4] 401203 0
Baseline, and at 3, 6 and 12 months after randomisation
Secondary outcome [5] 401948 0
Self-reported waist circumference
Timepoint [5] 401948 0
Baseline, and at 3, 6 and 12 months after randomisation

Eligibility
Key inclusion criteria
A person is eligible for inclusion if they are assessed at moderate to high risk of cardiovascular disease, as assessed by their GP and the CVD risk calculator/Guidelines for the management of Absolute cardiovascular disease risk.
A person may be eligible for inclusion if they have no known Coronary Artery Disease (CAD), or they are judged by their GP to be currently stable with a CAD diagnosis and free of clinical events for at least 6 months.
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People are not eligible for the study if:
• Their GP considers them to be ineligible due to the complexity of their condition or is aware of a circumstance that would impact on their ability to participate in the study.
• They are pregnant or planning to become pregnant.
• They have a medical condition that affects dietary intake, e.g., Conditions with swallowing difficulties, or restrictive exclusion diets.
• They are newly diagnosed with diabetes (< 3 months).
• They are unable to participate in telehealth dietary consultations due to disability or medical condition.
• They have been hospitalised or revascularized in the preceding 6 months.
• They have not been on a stable statin dose for the preceding 3 months.
• They do not have access to an email address or to the internet.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified by size of GP practice (1-5 GPs in practice />5 GPs in practice) and MMM category (3-5)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size: To detect a change in TC (primary outcome) of 0.51 mmol/L (SD=1.1), with 80% power and alpha 0.05, we need 74 people/group (37 men, 37 women). Allowing for a 25% drop out, this increases to 100/group. To account for clustering by GP practice, we assume 10 practices per arm, each contributing 10 people. The design effect, assuming an ICC of 0.05, is 1.45, meaning a final sample size of 145-150 per arm, or 15 practices per arm, each contributing 10 people (1 /week for 10 weeks), a total of 300 patients.
Statistical analysis: Linear mixed models will be used to analyse changes in outcomes, with a fixed effect for arm, and random effect for individual and cluster; the effect of the intervention will be based on the coefficient of the arm by time interaction term and adjusted for primary care service.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
17/02/2022
Actual
4/03/2022
Date of last participant enrolment
Anticipated
31/05/2023
Actual
21/07/2023
Date of last data collection
Anticipated
26/07/2024
Actual
Sample size
Target
300
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309736 0
Government body
Name [1] 309736 0
Australian Government
Country [1] 309736 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 310757 0
None
Name [1] 310757 0
Address [1] 310757 0
Country [1] 310757 0
Other collaborator category [1] 281987 0
Government body
Name [1] 281987 0
Hunter New England Central Coast Primary Health Network
Address [1] 281987 0
Suite 11, 125 Bull Street, Newcastle West, NSW 2302
Country [1] 281987 0
Australia
Other collaborator category [2] 281988 0
Other Collaborative groups
Name [2] 281988 0
Hunter Medical Research Institute
Address [2] 281988 0
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country [2] 281988 0
Australia
Other collaborator category [3] 281989 0
Charities/Societies/Foundations
Name [3] 281989 0
National Heart Foundation of Australia
Address [3] 281989 0
Level 3, 80 William Street East Sydney NSW 2011
Country [3] 281989 0
Australia
Other collaborator category [4] 281990 0
Government body
Name [4] 281990 0
NSW Regional Health Partners
Address [4] 281990 0
Wisteria Lodge, James Fletcher Hospital, 72 Watt Street, Newcastle, NSW, 2300
Country [4] 281990 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309493 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 309493 0
Ethics committee country [1] 309493 0
Australia
Date submitted for ethics approval [1] 309493 0
07/06/2021
Approval date [1] 309493 0
26/07/2021
Ethics approval number [1] 309493 0
H-2021-0193

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

Contacts
Principal investigator
Name 114342 0
Prof Laureate Professor Clare Collins
Address 114342 0
ATC Building, Room 310
University of Newcastle
Callaghan NSW 2308
Country 114342 0
Australia
Phone 114342 0
+61 2 492 15646
Fax 114342 0
Email 114342 0
[email protected]
Contact person for public queries
Name 114343 0
Laureate Professor Clare Collins
Address 114343 0
ATC Building, Room 310
University of Newcastle
Callaghan NSW 2308
Country 114343 0
Australia
Phone 114343 0
+61 2 492 15646
Fax 114343 0
Email 114343 0
[email protected]
Contact person for scientific queries
Name 114344 0
Laureate Professor Clare Collins
Address 114344 0
ATC Building, Room 310
University of Newcastle
Callaghan NSW 2308
Country 114344 0
Australia
Phone 114344 0
+61 2 492 15646
Fax 114344 0
Email 114344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data underlying published results
When will data be available (start and end dates)?
One year after main results publication and ending five years after main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal, and subject to approval by the principal investigator, on a case-by-case basis.
Available for what types of analyses?
Meta-analyses and analyses related to the stated aims of the study.
How or where can data be obtained?
By application to the principal investigator and subject to approval.
Email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13295Study protocolHealthyRHearts-reducing cholesterol in rural adults via telehealth-based medical nutrition therapy: protocol for a cluster randomised controlled trial', BMC CARDIOVASCULAR DISORDERS, 23 (2023)https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-023-03306-8  Not yet published.
13296Informed consent form    PDF to be attached when finalised.
13297Ethical approval    382821-(Uploaded-21-09-2021-10-00-00)-Study-related document.pdf
22312Study protocolJ. Herbert, T. Schumacher, L. J. Brown and C. E. Collins (2023); Developing a telehealth medical nutrition therapy (MNT) service for adults living in rural Australia at risk of cardiovascular disease: An intervention development study; J Hum Nutr Diet; Vol. 36 Issue 5 Pages 1782-1794; DOI: 10.1111/jhn.13193 https://onlinelibrary.wiley.com/doi/10.1111/jhn.13193 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHealthyRHearts - reducing cholesterol in rural adults via telehealth-based medical nutrition therapy: protocol for a cluster randomised controlled trial.2023https://dx.doi.org/10.1186/s12872-023-03306-8
N.B. These documents automatically identified may not have been verified by the study sponsor.