Host trial design
occlusive peripheral arterial disease, Stroke, PAD
PERIPHERAL ARTERIAL DISEASE, HEART, PAD, STROKE
The host trial is an RCT evaluating the effectiveness of an intensive lifestyle modification programme in participants with peripheral arterial disease (PAD). Participants who met the eligibility assessment criteria were identified from the outpatient PAD clinic at the University Hospital Galway, Ireland (UHG). Initial screening and randomization were carried out at the outpatient PAD clinic in UHG. The risk factor modification intervention programme was delivered in a nurse-led community-based centre (Croí Heart and Stroke Centre, Galway, Ireland), in the presence of a physiotherapist and nutritionist. The outpatient PAD clinic in UHG managed the control arm. The Department of Vascular and Endovascular Surgery, UHG, and the School of Medicine at the University of Galway served as the co-ordination centre. Patients were directly supervised during the intervention. The 12-week and 1-year follow-up examination and assessment took place at the outpatient PAD clinic in UHG [Eligibility criteria for inclusion and exclusion in the host trial have been mentioned in “The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme for a randomised controlled trial” protocol [Researchers screened the patient for inclusion and exclusion criteria. All potential participants with symptomatic PAD (Rutherford category 2 and above) [After meeting the inclusion criteria, screened patients were randomized to one of two treatment arms. One arm received the 12-week intensive risk factor modification intervention programme. The control arm was provided with standard care in the outpatient PAD clinic. The risk factor modification programme involved a weekly visit for 12 weeks and follow-up appointment for one year, whereas for standard care participants were given advice on the risk factor adjustment and reviewed at 12 weeks and followed up at 12 months.