Back to resultsTo Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. (PodPAD)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PAD tailored care
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- adult patient between the ages of 50-90 years,
- Patient attending for podiatry treatment
- diagnosis of PAD or is showing signs of symptoms of PAD
- wishes to take part in the study.
Exclusion Criteria:
- Anyone unable to give informed consent due to lack of mental capacity.
- Anyone who would be unable to participate in increased activity due to other co-morbidities
Sites / Locations
- Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
PAD tailored care
Outcomes
Primary Outcome Measures
Distance walked before onset of intermittent claudication
Distance walked before onset of intermittent claudication
Secondary Outcome Measures
Full Information
NCT ID
NCT02901847
First Posted
September 12, 2016
Last Updated
February 12, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02901847
Brief Title
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
Acronym
PodPAD
Official Title
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
PAD tailored care
Intervention Type
Other
Intervention Name(s)
PAD tailored care
Intervention Description
PAD tailored care
Primary Outcome Measure Information:
Title
Distance walked before onset of intermittent claudication
Description
Distance walked before onset of intermittent claudication
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patient between the ages of 50-90 years,
Patient attending for podiatry treatment
diagnosis of PAD or is showing signs of symptoms of PAD
wishes to take part in the study.
Exclusion Criteria:
Anyone unable to give informed consent due to lack of mental capacity.
Anyone who would be unable to participate in increased activity due to other co-morbidities
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
We'll reach out to this number within 24 hrs