Structured EDucation for Rehabilitation in Intermittent Claudication

NCT ID: NCT01776710

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-05-31

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).

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Structured education

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Sheffield Hallam University

OTHER

Sponsor Role: collaborator

University of York

OTHER

Sponsor Role: collaborator

University of Stirling

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Garry A Tew, PhD

Role: PRINCIPAL_INVESTIGATOR

University of York

Locations

Department of Health Sciences, University of York

York, North Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH17173

Identifier Type: -

Identifier Source: org_study_id