Status:
COMPLETED
Feasibility of a Multi Site RCT to Establish the Effectiveness of a Health Behaviour Change Intervention for Patients With Peripheral Arterial Disease (PAD).
Lead Sponsor:
NHS Grampian
Conditions:
Health Behavior
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study was to evaluate the feasibility of conducting a randomised controlled trial (RCT) comparing brief psychological intervention to help patients with Peripheral Arterial Disease...
Detailed Description
The aim of this study was to assess the feasibility of conducting a definitive multi-centre trial of a specially designed health behaviour change intervention delivered in a secondary care outpatient ...
Eligibility Criteria
Inclusion
- Adults over the age of 18 years
- Newly diagnosed with PAD resulting in claudication in one or both legs
- Reduced Ankle Brachial Index (ABI \< 0.80).
Exclusion
- Patients with an ABPI of less than 0.35, with rest pain or tissue loss were excluded and classified as cases of critical limb ischaemia requiring revascularisation.
- Severe mental health problems such as severe depression with suicidal ideation, psychosis, personality disorder
- Terminal illness
- Patients for whom it would be medically unadvisable to increase their daily walking (including heart failure, cancer, exercise induced asthma, unstable angina. Inability to walk unaided, history of orthopaedic surgery or significant bony disease impacting upon their mobility).
Key Trial Info
Start Date :
June 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04753281
Start Date
June 6 2019
End Date
November 5 2019
Last Update
February 15 2021
Active Locations (1)
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1
NHS Grampian
Aberdeen, AB25 2ZP, United Kingdom