Peripheral Arterial DiseaseSEDRICNCT01776710
Structured EDucation for Rehabilitation in Intermittent Claudication
A study testing Structured education in people with Peripheral Arterial Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Structured education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Health Sciences, University of York
York, North Yorkshire, YO105DD
About this study
Official title: 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).
- Conditions
- Peripheral Arterial Disease
- Being tested
- Structured education
- Keywords
- Intermittent claudication, Behavior therapy, Walking, Exercise, Patient education, Randomized controlled trial
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured education | Experimental | 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. Receives: Behavioral: Structured education |
| Standard care control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (5)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Health-related quality of life
Health-related quality of life will be assessed using the EuroQol EQ5D-5L questionnaire, and the Intermittent Claudication Questionnaire
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University, University of York, University of Stirling
- Responsible party
- Sponsor
- Investigators
- Garry A Tew, PhD, Principal investigator, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776710
- Sponsor's protocol ID
- STH17173
- Acronym
- SEDRIC
- Status last verified
- May 2017
- First submitted
- 23 Jan 2013
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Piloting of a Pragmatic Structured Education Programme That Promotes Walking in Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT01776710
- Acronym / sponsor ID
- SEDRIC / STH17173
- Conditions
- Peripheral Arterial Disease
- Keywords
- Intermittent claudication, Behavior therapy, Walking, Exercise, Patient education, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University, University of York, University of Stirling
- Study start
- Apr 2013 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured education | Experimental | Behavioral: Structured educationThe 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured educationThe 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. | Behavioural | Structured education |
Primary outcome
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.
5 secondary outcomes
Daily steps and physical activity
Time frame: 6 weeks
Claudication onset and maximum walking distances
Time frame: 6 weeks
Self-reported ambulatory ability
Time frame: 6 weeks
Health-related quality of life
Time frame: 6 weeks
Psychological constructs representing the key mediators of behaviour change
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garry A Tew, PhD principal investigator
University of York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured education in people with Peripheral Arterial Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.