Clinical trial NCT04753281: Feasibility of a Multi Site RCT to Establish the Effectiveness of a Health Behaviour Change Intervention for Patients With Peripheral Arterial Disease (PAD).
Official title: Feasibility of a Multi Site RCT to Establish the Effectiveness of a Health Behaviour Change Intervention for Patients With Peripheral Arterial Disease (PAD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: NHS Grampian
Sponsor class: OTHER_GOV
First posted: 2021-02-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 (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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Functional walking ability
timeFrame: 1 year study
Secondary outcomes:
measure: Anxiety and Depression
timeFrame: 1 year
measure: Emotional wellbeing
timeFrame: 1 year
measure: Health related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
state: Ab25 2zp
Study officials:
affiliation: NHSGRAMPIAM
name: Mary Mccallum
role: PRINCIPAL_INVESTIGATOR
References: