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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Disease
• Intervention / Treatment: Behavioral: MOSAIC

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • King's College Hospital NHS Foundation Trust
  • London, United Kingdom
    • Recruiting
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom
    • Recruiting
    • Guy's & St Thomas NHS Foundation Trust
  • London, United Kingdom
    • Recruiting
    • Lewisham and Greenwich NHS Trust (GSTT PIC site)
  • London, United Kingdom
    • Recruiting
    • St George's University Hospital NHS Foundation Trust
  • London, United Kingdom
    • Recruiting
    • The Royal London Hospital, Barts Heatth NHS Trust
  • Kent
    • Dartford, Kent, United Kingdom
      • Recruiting
      • Dartford and Gravesham NHS Trust (GSTT PIC site)
    • Maidstone, Kent, United Kingdom
      • Recruiting
      • Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
  • Surrey
    • Ashford, Surrey, United Kingdom
      • Recruiting
      • Ashford & St Peter's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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 Names: Motivating Structured walking Activity in IC
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Distance	6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Distance (6MWD)	6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.	Baseline and 3 months
Self-reported Maximum Walking Distance	Single global item	Baseline, 3 and 6 months
Self-Reported Walking Ability	Walking Estimated-Limitation Calculated by History (WELCH)	Baseline, 3 and 6 months
Activities of Daily Living	Nottingham Extended Activities of Daily Living (NEADL)	Baseline, 3 and 6 months
Health-Related Quality of Life	Vascular Quality of Life Questionnaire-6 (VascuQol-6)	Baseline, 3 and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Cognitions	Theory of Planned Behaviour Questionnaire	Baseline, 3 and 6 months
Illness Cognitions	Brief Illness Perceptions Questionnaire (BIPQ)	Baseline, 3 and 6 months
Walking Adherence	Exercise Adherence Rating Scale	Baseline, 3 and 6 months
Resource Use	Client Service Receipt Inventory	Baseline, 3 and 6 months
Health Related Quality of Life	Euroqol- 5D-5L	Baseline, 3 and 6 months
Pain Free Walking Ability	Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test	Baseline and 3 months
Maximal Walking Ability	The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London; The Dunhill Medical Trust
• Investigators: Principal Investigator: Sanjay Patel, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Anticipated): November 9, 2020
• Study Completion (Anticipated): January 9, 2021

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Walking; Illness Perceptions; Theory of Planned Behaviour; Six-Minute Walk Distance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 17/LO/0568; R477/0516 (Other Grant/Funding Number: Dunhill Medical Trust)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No