Structured EDucation for Rehabilitation in Intermittent Claudication

Peripheral Arterial Disease Clinical Trial

— SEDRIC  

Official title:

Development and Piloting of a Pragmatic Structured Education Programme That Promotes Walking in Patients With Intermittent Claudication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776710
• Other study ID #: STH17173
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: May 5, 2017
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2017
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A primary therapeutic goal for patients with intermittent claudication (IC) is to regain lost physical function through exercise rehabilitation. Supervised exercise programmes can markedly improve walking capacity, but these are resource intensive, National Health Service provision is limited, and patients cite accessing services as a barrier to participation.

Increasing walking activity via a structured education programme might be a pragmatic solution for improving walking capacity, health and wellbeing in patients with IC; however, further research is needed to substantiate this. Hence, the aim of this project is to develop a pragmatic education programme to increase walking in these patients and to collect data on its feasibility to inform the development of a definitive trial investigating clinical and cost effectiveness.

Focus groups will be conducted to inform the development of the education programme. Programme components will be theoretically-underpinned and evidence-based. The development of the programme will be an iterative process involving pilot work, feedback, evaluation, and revision. The programme will then be assessed in a randomised controlled pilot study with 6-week follow-up (n=30). We will assess the feasibility of the intervention and obtain preliminary data of its impact on important outcomes (daily steps/physical activity, walking capacity, quality of life, illness perceptions).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged >18 years with intermittent claudication due to peripheral arterial disease

• Stable disease for >3 months

• Able to provide consent

• Able to read and speak English to a level allowing satisfactory completion of written questionnaires and to participate in the education intervention

Exclusion Criteria:

• Previous endovascular/surgical interventions

• Scheduled endovascular/surgical intervention

• Critical limb ischaemia

• Those whose function is uniquely impaired, e.g. wheelchair-bound patients and patients with lower-extremity amputation(s)

• Presence of contraindications to exercise or co-morbidities that limit exercise performance to a greater extent than the intermittent claudication (e.g. severe arthritis)

• Major surgery, myocardial infarction or stroke/transient ischemic attack in the previous 6 months

• Patients who already perform greater than 30 min of structured exercise three times weekly (self-reported)

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Structured education
The structured education intervention will comprise a 3-hour education workshop delivered by two trained facilitators and a follow-up telephone call 2 weeks later. The aims of the education programme are to enhance patients' understanding of peripheral arterial disease and intermittent claudication, and to support patients in increasing their daily walking activity. Key behaviour change techniques that will be incorporated will include goal setting, action planning, barrier identification/problem solving, prompt review of behavioural goals, prompt self-monitoring of behaviour, and instructions on how to perform the behaviour.

Locations

Country	Name	City	State
United Kingdom	Department of Health Sciences, University of York	York	North Yorkshire

Sponsors (4)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield Hallam University, University of Stirling, University of York

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants' experiences	We aim to explore participants' experiences at the end of the 6-week follow-up visit via a one-to-one semi-structured interview (up to 1 hour; audio-recorded and transcribed). Issues discussed will include quality of life, function and attitudes to walking, the acceptability of the intervention and outcomes measures, and the strength of preferences for either the intervention or control arms.	6 weeks
Primary	Feasibility	The feasibility of the structured education programme will be assessed in terms of recruitment, retention, compliance and acceptability, the latter of which will assessed via participant interviews.	6 weeks
Secondary	Daily steps and physical activity	Daily steps and physical activity will be measured objectively using Actigraph GT3X+ accelerometers. Participants will wear this device for seven consecutive days. A 'valid day' will consist of at least 10 h of accelerometer movement data and participants with less than 4 days (3 weekdays and 1 weekend day) of valid wear will be excluded from the analysis.	6 weeks
Secondary	Claudication onset and maximum walking distances	Claudication onset and maximum walking distances will be assessed using an incremental treadmill test and a 6-min corridor walking test. The treadmill protocol will start at 3.2 km/hr, 0% grade for 2 minutes, with 2% increases in grade every 2 minutes up to 18%, which is maintained until the patient needs to stop.	6 weeks
Secondary	Self-reported ambulatory ability	Self-reported ambulatory ability will be assessed using the Walking Impairment Questionnaire and the Estimation of Ambulatory Capacity by History Questionnaire.	6 weeks
Secondary	Health-related quality of life	Health-related quality of life will be assessed using the EuroQol EQ5D-5L questionnaire, and the Intermittent Claudication Questionnaire	6 weeks
Secondary	Psychological constructs representing the key mediators of behaviour change	Psychological constructs representing the key mediators of behaviour change suggested by the underpinning theories will also be assessed including: Illness perceptions (The Brief Illness Perception Questionnaire), walking self-efficacy, barrier self-efficacy, and action planning.	6 weeks