Motivating Structured Walking Activity in Intermittent Claudication

Peripheral Arterial Disease Clinical Trial

— MOSAIC  

Official title:

A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238222
• Other study ID #: 17/LO/0568
• Secondary ID: R477/0516
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: January 9, 2021

Study information

• Verified date: December 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Julie S Bieles, PhD
• Phone: 02078486321
• Email: julie.s.bieles[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: January 9, 2021
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Ashford & St Peter's NHS Foundation Trust	Ashford	Surrey
United Kingdom	Dartford and Gravesham NHS Trust (GSTT PIC site)	Dartford	Kent
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	Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)	Maidstone	Kent

Sponsors (3)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London, The Dunhill Medical Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Cognitions	Theory of Planned Behaviour Questionnaire	Baseline, 3 and 6 months
Other	Illness Cognitions	Brief Illness Perceptions Questionnaire (BIPQ)	Baseline, 3 and 6 months
Other	Walking Adherence	Exercise Adherence Rating Scale	Baseline, 3 and 6 months
Other	Resource Use	Client Service Receipt Inventory	Baseline, 3 and 6 months
Other	Health Related Quality of Life	Euroqol- 5D-5L	Baseline, 3 and 6 months
Other	Pain Free Walking Ability	Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test	Baseline and 3 months
Other	Maximal Walking Ability	The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test	Baseline and 3 months
Primary	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	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
Secondary	Self-reported Maximum Walking Distance	Single global item	Baseline, 3 and 6 months
Secondary	Self-Reported Walking Ability	Walking Estimated-Limitation Calculated by History (WELCH)	Baseline, 3 and 6 months
Secondary	Activities of Daily Living	Nottingham Extended Activities of Daily Living (NEADL)	Baseline, 3 and 6 months
Secondary	Health-Related Quality of Life	Vascular Quality of Life Questionnaire-6 (VascuQol-6)	Baseline, 3 and 6 months