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Structured EDucation for Rehabilitation in Intermittent Claudication (SEDRIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
Sheffield Hallam University
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01776710
First received: January 23, 2013
Last updated: April 25, 2013
Last verified: February 2013

January 23, 2013
April 25, 2013
April 2013
April 2014   (final data collection date for primary outcome measure)
Feasibility [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01776710 on ClinicalTrials.gov Archive Site
  • Daily steps and physical activity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.
  • Claudication onset and maximum walking distances [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.
  • Self-reported ambulatory ability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Self-reported ambulatory ability will be assessed using the Walking Impairment Questionnaire and the Estimation of Ambulatory Capacity by History Questionnaire.
  • Health-related quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Health-related quality of life will be assessed using the EuroQol EQ5D-5L questionnaire, and the Intermittent Claudication Questionnaire
  • Psychological constructs representing the key mediators of behaviour change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Participants' experiences [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Same as current
 
Structured EDucation for Rehabilitation in Intermittent Claudication
Development and Piloting of a Pragmatic Structured Education Programme That Promotes Walking in Patients With Intermittent Claudication

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Arterial Disease
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.
  • 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.
    Intervention: Behavioral: Structured education
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
April 2014
April 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Garry A Tew, PhD +44(0)1142252358 g.tew@shu.ac.uk
United Kingdom
 
NCT01776710
STH17173
No
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
Principal Investigator: Garry A Tew, PhD Sheffield Hallam University
Sheffield Teaching Hospitals NHS Foundation Trust
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP