U-DECIDE: Utilising technology for Diet & Exercise Change In complex chronic conditions across Diverse Environments: Protocol for a Randomised Controlled Trial (Preprint)

BACKGROUND Background: The metabolic syndrome (MetS) is common across many complex chronic disease groups. Advances in health technology have provided opportunities to support lifestyle interventions. Implementation of health technology driven services in a tertiary setting remains untested. OBJECTIVE The purpose of this study is to test the feasibility of a health technology-assisted lifestyle intervention in a patient-led model of care. METHODS Methods: The study is a single-centre, 26-week randomised controlled trial. The setting is specialist kidney and liver disease clinics at a large Australian tertiary hospital. The participants will be adults with a complex chronic condition who are referred for dietetic assessment and display at least one feature of the MetS. All participants will receive an individualised assessment and advice on diet quality from a dietitian, a wearable activity monitor and standard care. Participants randomised to the intervention group will receive access to a suite of health technologies from which to choose, including common base components (text messages) and optional components (online and mobile app based nutrition information; online home exercise program; group-based videoconferencing). Exposure to the optional aspects of the intervention will be patient-led, with participants choosing their preferred level of engagement. The primary outcome will be the feasibility of delivering the program, determined by safety, recruitment rate, retention, exposure uptake and telehealth adherence. Secondary outcomes will be clinical effectiveness, patient-led goal attainment, treatment fidelity, exposure demand and participant perceptions. Primary outcome data will be assessed descriptively, and secondary outcomes will be assessed using ANCOVA. This study will provide evidence on the feasibility of the intervention in a tertiary setting for patients with complex chronic disease exhibiting features of the MetS. RESULTS Results: The study was funded in 2019. Enrolment has commenced and is expected to be completed by June 2022. Data collection and follow up are expected to be completed by December 2022. Results from the analyses based on primary outcomes are expected to be submitted for publication by June 2023. CONCLUSIONS Conclusions: The study will test the implementation of a health technology assisted lifestyle intervention in a tertiary outpatient setting for a diverse group of patients with complex chronic conditions. It is novel in that it embeds patient choice into intervention exposure and will inform health services decision makers in regards to the feasibility of scale and spread of technology-assisted access to care for a broader reach of specialist services. CLINICALTRIAL Australian New Zealand Clinical Trial Registry (http://www.anzctr.org.au/): ACTRN12620001282976.