Motivating Structured Walking Activity in Intermittent Claudication
NCT ID: NCT03238222
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
192 participants
INTERVENTIONAL
2017-11-10
2021-01-09
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
MOSAIC
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.
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.
No interventions assigned to this group
Interventions
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MOSAIC
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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King's College London
OTHER
The Dunhill Medical Trust
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Sanjay Patel
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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Dartford and Gravesham NHS Trust (GSTT PIC site)
Dartford, Kent, United Kingdom
Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
Maidstone, Kent, United Kingdom
Ashford & St Peter's NHS Foundation Trust
Ashford, Surrey, United Kingdom
Guy's & St Thomas NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Lewisham and Greenwich NHS Trust (GSTT PIC site)
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
St George's University Hospital NHS Foundation Trust
London, , United Kingdom
The Royal London Hospital, Barts Heatth NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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References
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Bearne LM, Volkmer B, Peacock J, Sekhon M, Fisher G, Galea Holmes MN, Douiri A, Amirova A, Farran D, Quirke-McFarlane S, Modarai B, Sackley C, Weinman J, Bieles J; MOSAIC Trial Collaboration. Effect of a Home-Based, Walking Exercise Behavior Change Intervention vs Usual Care on Walking in Adults With Peripheral Artery Disease: The MOSAIC Randomized Clinical Trial. JAMA. 2022 Apr 12;327(14):1344-1355. doi: 10.1001/jama.2022.3391.
Other Identifiers
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R477/0516
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
17/LO/0568
Identifier Type: -
Identifier Source: org_study_id