Development and Piloting of a Pragmatic Structured Education Programme That Promotes Walking in Patients With Intermittent Claudication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Structured education (Behavioral)
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.
结局指标
主要结局
Feasibility
时间窗: 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.
次要结局
- Claudication onset and maximum walking distances(6 weeks)
- Psychological constructs representing the key mediators of behaviour change(6 weeks)
- Health-related quality of life(6 weeks)
- Daily steps and physical activity(6 weeks)
- Self-reported ambulatory ability(6 weeks)