Feasibility of a Multi Site RCT to Establish the Effectiveness of a Health Behaviour Change Intervention for Patients With Peripheral Arterial Disease (PAD).

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 (PAD), reduce cardiovascular risk factors compared to control/treatment as usual in a vascular outpatient clinic. Trial feasibility was defined as the successful recruitment and retention of participants, adherence to the intervention, identification of barriers to the intervention and collection of clinical and quality of life outcome data. Qualitative data was collected to evaluate participant experience and the clinical impact of a supported self-management intervention delivered in a routine clinical setting.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Other: Lifestyle counselling

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 clinic to improve the primary clinical outcome of functional walking ability This feasibility study, based on the MRC framework for assessing feasibility and piloting methods, will assess the relative strengths and weaknesses of the intervention and study design, as well as pave the way for a larger and more definitive trial.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ab25 2zp
    • Aberdeen, Ab25 2zp, United Kingdom
      • NHS Grampian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual
Other: Lifestyle counselling; Participants will receive an assessment appointment and up to 8 follow up sessions with a Health Psychologist to help them set goals and monitor changes of their own self management behaviour.	Other: Lifestyle counselling; brief psychological intervention, based on the behaviour change whee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional walking ability	To establish feasibility of a large scale RCT of a specifically designed health behaviour change intervention to improve functional walking ability in adults with PAD. We will use the standard measure of functional walking.	1 year study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and Depression	The Chief Investigator (CI) will administer brief, self-report inventories at baseline, 3 months and 6 months follow-up to establish participants': anxiety and depression measured using Hospital Anxiety and Depression Scale, (HADS).	1 year
Emotional wellbeing	The Chief Investigator (CI) will administer brief, self-report inventories at baseline, 3 months and 6 months follow-up to establish participants': positive emotional wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale Scored 1-5 (1 being none of the time and 5 being all of the time).	1 year
Health related quality of life	The Chief Investigator (CI) will administer brief, self-report inventories at baseline, 3 months and 6 months follow-up to establish participants': health-related quality of life measured using EQ-5D-5L *EQ-5D-5L Scored -10 -100. (-10 being the worst health you can imagine and 100 being the best health you can imagine).	1 year

Collaborators and Investigators

• Sponsor: NHS Grampian
• Investigators: Principal Investigator: Mary Mccallum, NHSGRAMPIAM

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Actual): November 5, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

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: 240417

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