The Holistic Peripheral Artery Disease Management Trial (OPTIMAL)

The intervention arm will receive the PAD-medical program for a period of six months. This is a telehealth-delivered program supporting people with PAD to manage relevant risk factors. Telehealth will involve videoconferencing between the study staff, located at James Cook University and the Townsville University Hospital, and participants in their own homes. Participants will use the Queensland Health 'pexip' application to videoconference with study staff, using their own smart devices if available, or using an iPad provided to them. The PAD-medical program includes the following components: 1) Support for regular home-based risk factor monitoring, including measuring blood pressure once daily and blood glucose three times daily. Blood pressure monitors and blood glucose monitors will be provided if participants do not already own a suitable monitor, and will receive instruction on correct monitoring technique and the recording of results during the induction visit. Participants will also receive reminders during the scheduled telehealth consultations with the study nurses and doctor to monitor their blood pressure and blood glucose. 2) Medication optimisation through videoconferencing. A study doctor/clinical nurse team will host audiovisual consultations with participants to review the results of their home-based risk factor monitoring, and other risk factors (glycated hemoglobin [HbA1c], smoking status, anti-platelet prescription status, and low density-lipoprotein-c [LDL-c]). Existing medications will be changed and new medications added if needed to optimise control of these risk factors according to current clinical guidelines (Asian Pacific Society of Atherosclerosis and Vascular Diseases, European Society of Cardiology, Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischaemia, and the American College of Cardiology & American Heart Association), to achieve the following targets: systolic blood pressure <140 mmHg, LDL-c <1.8 mMol, HbA1c <7%, smoking abstinence, and daily anti-platelet use. Medications will be focused on statins, ezetimibe, angiotensin converting enzyme inhibitors, thiazides, metformin, SGLT inhibitors, low dose aspirin and low dose rivaroxaban. The consultations will occur at baseline, 2 weeks, 4 weeks, 6 weeks, 12 weeks and 18 weeks. In addition to home-based blood pressure and blood glucose monitoring, HbA1c and LDL-c will be monitored by blood tests at baseline, six weeks, 12 weeks and 18 weeks. Additional risk factor monitoring (blood tests for HbA1c and LDL-c) will be ordered by the study doctor for each participant if deemed necessary (e.g. to monitor effectiveness of newly prescribed medications). 3) Exercise sessions through videoconferencing. An accredited exercise physiologist will conduct small, group-based exercise sessions with participants. This will occur twice weekly for the first 3 months, and once weekly for the second 3 months, whilst also encouraging participants to do the exercises at home outside of the scheduled sessions. The supervised exercise sessions will include up to six participants, and run for 60 minutes, 30-minutes of which will include actual exercises, involving a repeated sequence of 10 exercises over 5-minutes. The exercise sequence was designed to require minimal space, and no specialised equipment, and includes the following exercises: marching on the spot, calf and toe raises, knee lifts, butt kicks, side steps, toe backwards taps, heel forward taps, toe side taps, and squats. Each exercise has regression (easier) and progression (harder) versions which individual participants may choose to perform as needed based on fitness level and claudication pain. Exercise intensity is intended to be moderate, where intermittent claudication pain levels reach moderate severity (3 to 4 out of 5) as indicated in current guidelines (ESSA position statement on exercise prescription for patients with PAD, and the scientific statement from the American Heart Association). The exercise physiologist will also conduct pre- and post-exercise safety checks with each participant. 4) Smoking cessation counselling through videoconferencing. For participants that are active smokers and want to quit smoking, a trained counsellor will deliver at least five monthly 30-minute sessions to each participant. Participants can request up to an additional five monthly sessions if needed (maximum of two per month). The sessions will involve the provision and education of pharmacological quitting aids (from the RACGP support smoking cessation guidelines) in conjunction with the study doctor, and individualised counselling on quitting using the 5As framework. Adherence to the components of the intervention described above will be monitored through a self-reported diary for recording blood pressure and blood glucose measurements, and participation logs for the consultation sessions made by the study nurses, doctor, accredited exercise physiologist, and smoking cessation counsellor.