Structured EDucation for Rehabilitation in Intermittent Claudication (SEDRIC)

Study Description

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Brief 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).

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Behavioral: Structured education	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	51 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Development and Piloting of a Pragmatic Structured Education Programme That Promotes Walking in Patients With Intermittent Claudication
Actual Study Start Date :	April 2013
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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.	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.
No Intervention: Standard care control; Standard care will consist of general advice to increase walking and an information sheet on peripheral arterial disease, plus a consultation with a Consultant Vascular Surgeon.

Outcome Measures

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Primary Outcome Measures :

1. Feasibility [ Time Frame: 6 weeks ]
   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.

Secondary Outcome Measures :

1. Daily steps and physical activity [ Time Frame: 6 weeks ]
   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.
2. Claudication onset and maximum walking distances [ Time Frame: 6 weeks ]
   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.
3. Self-reported ambulatory ability [ Time Frame: 6 weeks ]
   Self-reported ambulatory ability will be assessed using the Walking Impairment Questionnaire and the Estimation of Ambulatory Capacity by History Questionnaire.
4. Health-related quality of life [ Time Frame: 6 weeks ]
   Health-related quality of life will be assessed using the EuroQol EQ5D-5L questionnaire, and the Intermittent Claudication Questionnaire
5. Psychological constructs representing the key mediators of behaviour change [ Time Frame: 6 weeks ]
   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.

Other Outcome Measures:

1. Participants' experiences [ Time Frame: 6 weeks ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
Department of Health Sciences, University of York
York, North Yorkshire, United Kingdom, YO105DD

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield Hallam University

University of York

University of Stirling

Investigators

Principal Investigator:	Garry A Tew, PhD	University of York

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01776710 History of Changes
Other Study ID Numbers:	STH17173
First Posted:	January 28, 2013
Last Update Posted:	May 9, 2017
Last Verified:	May 2017

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Intermittent claudication; Behavior therapy; Walking	Exercise; Patient education; Randomized controlled trial

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication; Atherosclerosis; Arteriosclerosis	Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms