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

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ClinicalTrials.gov Identifier: NCT02901847
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: PAD tailored care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : September 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

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Arms and Interventions
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Arm Intervention/treatment
Intervention
PAD tailored care
 Other: PAD tailored care
PAD tailored care


Outcome Measures
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Primary Outcome Measures :
  1. Distance walked before onset of intermittent claudication [ Time Frame: 6 months ]
    Distance walked before onset of intermittent claudication


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901847


Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
More Information
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02901847     History of Changes
Other Study ID Numbers: STH19410
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases