Multidisciplinary Team-based approach to guide secondary risk prevention for cardiovascular and limb outcomes in patients with Peripheral Artery Disease (TEAM-PAD): A Randomised Controlled Trial

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12623000995673
• Lead Sponsor: Investigator initiated study, sponsored by Vascular Department, Concord Repatriation General Hospital, SLHD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-13
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Aged 18 years and above
2. Receiving outpatient care for PAD in the Concord Repatriation General Hospital vascular surgery clinics (in 3 West or High Risk Foot Clinic), inpatient care under the vascular department at Concord Repatriation General Hospital, or directly referred to study investigators from private consulting rooms of Concord Repatriation General Hospital affiliated vascular surgeons.
OR Receiving outpatient care for PAD in the Royal Prince Alfred Hospital vascular surgery clinics (or High Risk Foot Clinic)
OR Receiving outpatient care for PAD in the Nepean Hospital vascular surgery clinics (or High Risk Foot Clinic)
3. Evidence of PAD defined by either Ankle Brachial Index (ABI) < 0.9 or Toe Brachial Index (TBI) < 0.6
OR Previous vascular surgical or endovascular intervention for PAD
OR Other means of diagnosing PAD (medical imaging, clinical grading)

Exclusion Criteria

1. Patients who do not provide consent due to incapacity to consent or who decline to participate.
2. Patients who have a life limiting condition (terminal illness or estimated life expectancy less than one year) and would not benefit from being included in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 10-year cardiovascular risk percentage from baseline to 9 months according to the SmartREACH model<br><br>The data used to calculate the risk percentage using the SmartREACH model will be sourced from patient questionnaires completed during face-to-face clinical assessments and review of the electronic medical record, at baseline and 9 months after randomisation follow-up appointments. [ 9 months post-randomisation]