A Multimodal Tele-health Behavioural Intervention in Patients With Peripheral Arterial Disease From Low Socio-economic Areas: a Feasibility and Pilot Randomized Controlled Trial With Embedded Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acceptability of the program
研究概览
简要总结
Peripheral arterial disease is a common, under-treated and under-researched issue. The vast majority of these patients often have multiple issues which can be improved with targeted behavioural change interventions. NICE has recommended that supervised exercise is the mainstay of treatment for intermittent claudication (ischaemic muscle pain on walking due to blocked and narrowed arteries). However, in the vast majority of UK hospitals, this isn't undertaken, and with the issues around group-based sessions and repeated visits to hospitals, this treatment option is not available with the coronavirus pandemic.
This is a single-centre randomised control trial in 60 patients with peripheral arterial disease attending the Freeman Hospital. Patients will be randomised to either an enhanced behavioural change intervention targeting multiple health behaviours vs a simple walking intervention. Also, some patients will be involved in focus groups to understand their experience of the intervention and whether it is feasible and acceptable, allowing changes to be made to the program.
The primary outcome will be to assess the feasibility and acceptability of the program. We will also be assessing multiple secondary outcomes including functional capacity, quality of life, sleep quality and smoking and alcohol reduction.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PAD confirmed by ankle-brachial index <0.90 in one or both limbs
- •Age >= 40 years
- •Able to walk distance >50m
- •Live in an area deemed in lowest 30% of super output area from Office of National Statistics
排除标准
- •chronic limb threatening ischemia
- •short claudication distance <50m
- •severe heart disease (Grade III or IV, New York Heart Association)
- •severe ischemic or haemorrhagic stroke or neurodegenerative diseases
- •severe hypertension (systolic blood pressure of more than 180 mm Hg, and a diastolic
- •blood pressure of more than 100 mm Hg)
- •uncontrolled cardiac arrhythmias (unstable angina during the previous month and
- •myocardial infarction during the previous month)
- •a resting heart rate of more than 120 beats per minute
- •has already undergone angioplasty, bypass or other surgical intervention for PAD
- •other severe comorbid conditions preventing the ability to engage in physical activity,
- •inability or unwillingness to undertake the commitments of the study
结局指标
主要结局
Acceptability of the program
时间窗: post 12 weeks
Patient acceptability of the intervention and study experience more broadly will be determined through semi-structured qualitative 1-2-1 interviews and/or focus groups.
Feasibility of the program
时间窗: post 12 weeks
Feasibility will be determined by calculating the rate of patient screening, eligibility, recruitment, retention at 12 weeks and adherence to the intervention (number of sessions attended and completed)
次要结局
- EuroQoL questionnaire (EQ-5D-5L).(pre and post-12 weeks)
- Physical activity levels (Fitbit Charge HR)(pre and post-12 weeks)
- Walking Impairment Questionnaire (WIQ)(pre and post-12 weeks)
- Short Form Dietary Questionnaire(pre and post-12 weeks)
- Patient activation(pre and post-12 weeks)
- Walking Estimated Limitation Calculated by History (WELCH) questionnaire(pre and post-12 weeks)
- Six-minute walk test (6MWT)(pre and post-12 weeks)
- Sleep(pre and post-12 weeks)
- Mental wellbeing(pre and post-12 weeks)
- Vascular quality of life questionnaire (VascuQoL-6)(pre and post-12 weeks)
- Resource utilisation(pre and post-12 weeks)
- Alcohol and tobacco use(pre and post-12 weeks)
研究者
Gabriel Cucato
Vice Chancellor Research Fellow
Northumbria University