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

NHS Grampian

Status: Completed

Conditions: Health Behavior

Treatments: Other: Lifestyle counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT04753281

240417

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

43 participants in 2 patient groups

Lifestyle counselling

Other group

Description:

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.

Treatment:

Other: Lifestyle counselling

Treatment as usual

No Intervention group

Description:

Treatment as usual