To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. (PodPAD)

The aim of the project is to investigate the clinical and patient centred outcomes of people with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. The podiatry clinic will be delivered from the Move More centre (NCSEM) and participants will be encouraged to access these facilities as part of their activity programme which will be agreed with the physical activity team. Primary and secondary outcomes will be clinical - claudication pain, distance walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with the programme will also be assessed.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: PAD tailored care

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S10 2JF
    • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. adult patient between the ages of 50-90 years,
2. Patient attending for podiatry treatment
3. diagnosis of PAD or is showing signs of symptoms of PAD
4. wishes to take part in the study.

Exclusion Criteria:

1. Anyone unable to give informed consent due to lack of mental capacity.
2. Anyone who would be unable to participate in increased activity due to other co-morbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; PAD tailored care	Other: PAD tailored care; PAD tailored care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance walked before onset of intermittent claudication	Distance walked before onset of intermittent claudication	6 months

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: STH19410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No