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

Health Behavior Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753281
• Other study ID #: 240417
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: November 5, 2019

Study information

• Verified date: February 2021
• Source: NHS Grampian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Health Behavior
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Lifestyle counselling
brief psychological intervention, based on the behaviour change whee

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen	Ab25 2zp

Sponsors (1)

Lead Sponsor	Collaborator
NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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