Motivating Structured Walking Activity in Intermittent Claudication (MOSAIC)
A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial
Peripheral arterial disease can cause leg pain or discomfort (called intermittent claudication (IC)), which limits the ability to walk and carry out everyday activities. Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge to begin and then continue. The aim of this study is to investigate if a physiotherapist-led, behaviour change treatment effects walking in people with IC. The treatment is designed to build an understanding of IC and walking exercise and help individuals develop strategies to increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC. All participants will visit King's College London or their local hospital to complete two short walking tests and answer questionnaires about their daily activities, beliefs about their symptoms and treatment, quality of life and the costs of having IC.
Participants will then be randomly assigned to receive either the new treatment or continue with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at the participant's home or local hospital) and two 20-minute telephone calls with a physiotherapist who will discuss participants' understanding and beliefs about IC, walking and help participants to set goals and plans to increase walking over 12 weeks. Participants will be provided with a step counter (pedometer) and walking record.
After 12 weeks, all participants will attend a second appointment where they will repeat the walking tests and fill out another set of questionnaires. A final set of questionnaires will be completed by all participants after 6 months (by post or electronically). Some participants will be invited to provide feedback on their experience of the treatment and trial by telephone or a face-to-face interview with a researcher.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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London、英国
- 招聘中
- King's College Hospital NHS Foundation Trust
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London、英国
- 招聘中
- Royal Free London NHS Foundation Trust
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London、英国
- 招聘中
- Guy's & St Thomas NHS Foundation Trust
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London、英国
- 招聘中
- Lewisham and Greenwich NHS Trust (GSTT PIC site)
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London、英国
- 招聘中
- St George's University Hospital NHS Foundation Trust
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London、英国
- 招聘中
- The Royal London Hospital, Barts Heatth NHS Trust
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Kent
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Dartford、Kent、英国
- 招聘中
- Dartford and Gravesham NHS Trust (GSTT PIC site)
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Maidstone、Kent、英国
- 招聘中
- Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
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Surrey
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Ashford、Surrey、英国
- 招聘中
- Ashford & St Peter's NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ≥50 years of age;
- established PAD (Ankle Brachial Pressure Index ≤0.90 and/or radiographic evidence or clinician reported diagnosis) and IC (presence of symptoms reported on the San Diego Claudication Questionnaire)
- able to participate in MOSAIC
- able and willing to provide informed consent
Exclusion Criteria:
- Unstable IC (self-reported change in symptoms during previous 3 months)
- walking >90 minutes/week (reported on Brief International Physical Activity Questionnaire
- contraindications to walking exercise (e.g., unstable angina) confirmed by their vascular specialist
- have completed any prescribed supervised exercise sessions in the previous 6 months or been offered prescribed exercise sessions in the next 6 months.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MOSAIC Treatment
MOSAIC treatment plus Usual NHS Care.
MOSAIC treatment comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) with a trained physiotherapist.
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MOSAIC comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) delivered at a convenient time and location of participant's choice (local NHS Trust or participant's home).
All sessions are delivered by a trained Band 6/7 physiotherapist.
All participants randomized to receive MOSAIC will be provided with a pedometer and a patient manual which will include information on intermittent claudication, risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary.
其他名称：
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无干预：Usual Care Comparison
Usual NHS care for people with intermittent claudication typically consists of an initial assessment, drug therapy and simple advice to walk provided by a vascular specialist and delivered in the vascular outpatient clinic.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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6 Minute Walk Distance
大体时间：3 months
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6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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6 Minute Walk Distance (6MWD)
大体时间：Baseline and 3 months
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6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.
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Baseline and 3 months
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Self-reported Maximum Walking Distance
大体时间：Baseline, 3 and 6 months
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Single global item
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Baseline, 3 and 6 months
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Self-Reported Walking Ability
大体时间：Baseline, 3 and 6 months
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Walking Estimated-Limitation Calculated by History (WELCH)
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Baseline, 3 and 6 months
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Activities of Daily Living
大体时间：Baseline, 3 and 6 months
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Nottingham Extended Activities of Daily Living (NEADL)
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Baseline, 3 and 6 months
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Health-Related Quality of Life
大体时间：Baseline, 3 and 6 months
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Vascular Quality of Life Questionnaire-6 (VascuQol-6)
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Baseline, 3 and 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment Cognitions
大体时间：Baseline, 3 and 6 months
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Theory of Planned Behaviour Questionnaire
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Baseline, 3 and 6 months
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Illness Cognitions
大体时间：Baseline, 3 and 6 months
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Brief Illness Perceptions Questionnaire (BIPQ)
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Baseline, 3 and 6 months
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Walking Adherence
大体时间：Baseline, 3 and 6 months
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Exercise Adherence Rating Scale
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Baseline, 3 and 6 months
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Resource Use
大体时间：Baseline, 3 and 6 months
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Client Service Receipt Inventory
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Baseline, 3 and 6 months
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Health Related Quality of Life
大体时间：Baseline, 3 and 6 months
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Euroqol- 5D-5L
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Baseline, 3 and 6 months
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Pain Free Walking Ability
大体时间：Baseline and 3 months
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Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test
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Baseline and 3 months
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Maximal Walking Ability
大体时间：Baseline and 3 months
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The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test
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Baseline and 3 months
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合作者和调查者
调查人员
- 首席研究员：Sanjay Patel、Guy's and St Thomas' NHS Foundation Trust
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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