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

NCT04753281 | Completed

• 1 other identifier: 240417
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Anxiety and Depression

  1 year

• Emotional wellbeing

  1 year

• Health related quality of life

  1 year

Study Arms (2)

Lifestyle counselling

OTHER

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

Treatment as usual

NO INTERVENTION

Treatment as usual

Interventions

Lifestyle counselling OTHER

brief psychological intervention, based on the behaviour change whee

Lifestyle counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• NHS Grampian: lead

Study Sites (1)

NHS Grampian

Aberdeen, AB25 2ZP, United Kingdom

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mary Mccallum

  NHSGRAMPIAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 15, 2021
• Study Start: June 6, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)