Health Behavior
Conditions
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.
Interventions
brief psychological intervention, based on the behaviour change whee
Sponsors
NHS Grampian
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional walking ability | 1 year study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and Depression | 1 year | 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). |
| Emotional wellbeing | 1 year | 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). |
| Health related quality of life | 1 year | 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). |
Countries
United Kingdom
Outcome results
None listed