None listed
Conditions
Brief summary
People who live in rural areas of Australia have higher rates of heart disease. Nutrition impacts on many of the risk factors for heart disease, making it a key lifestyle factor to focus on. However, access to qualified health professionals with the skills and knowledge assist with this can be limited in these areas. This randomised controlled trial will test the effectiveness of five telehealth consultations with a specially trained Accredited Practising Dietitian (APD) for rural people who are at moderate to high risk of heart disease. The study participants will also get the usual care they would normally receive from their General Practitioner (GP). The control group in this instance will receive usual care, as offered by their GP. Both groups will also receive personalised feedback on their nutrition via the Australian Eating Survey - Heart Version. Study participants must be categorised as living in an area classed as 3-7 by the Modified Monash Model, a measure of rurality, and receive a letter of invitation from their GP. Our study will look at the changes in blood cholesterol over 12 months, and will compare the results of those who had consultations with APDs against those who did not. We shall also investigate blood pressure, weight and waist circumference. We believe that the series of five consultations with health professionals with specialised training in nutrition will be cost effective in reducing the risk of heart disease in rural adults.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.