An interventional study of Lifestyle counselling in Health Behavior, sponsored by NHS Grampian. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-15.
Sponsored by NHS Grampian · Not applicable, Interventional, and Prevention
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 43 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →NHS Grampian is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
brief psychological intervention, based on the behaviour change whee
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.
Time frame: 1 year study
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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NHS Grampian