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Motivating Structured Walking Activity in Intermittent Claudication (MOSAIC)

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ClinicalTrials.gov Identifier: NCT03238222
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : May 28, 2018
Sponsor:
Collaborators:
King's College London
The Dunhill Medical Trust
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Intermittent Claudication Peripheral Vascular Disease Behavioral: MOSAIC Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. 6 Minute Walk Distance [ Time Frame: 3 months ]
    6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.


Secondary Outcome Measures :
  1. 6 Minute Walk Distance (6MWD) [ Time Frame: Baseline and 3 months ]
    6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.

  2. Self-reported Maximum Walking Distance [ Time Frame: Baseline, 3 and 6 months ]
    Single global item

  3. Self-Reported Walking Ability [ Time Frame: Baseline, 3 and 6 months ]
    Walking Estimated-Limitation Calculated by History (WELCH)

  4. Activities of Daily Living [ Time Frame: Baseline, 3 and 6 months ]
    Nottingham Extended Activities of Daily Living (NEADL)

  5. Health-Related Quality of Life [ Time Frame: Baseline, 3 and 6 months ]
    Vascular Quality of Life Questionnaire-6 (VascuQol-6)


Other Outcome Measures:
  1. Treatment Cognitions [ Time Frame: Baseline, 3 and 6 months ]
    Theory of Planned Behaviour Questionnaire

  2. Illness Cognitions [ Time Frame: Baseline, 3 and 6 months ]
    Brief Illness Perceptions Questionnaire (BIPQ)

  3. Walking Adherence [ Time Frame: Baseline, 3 and 6 months ]
    Exercise Adherence Rating Scale

  4. Resource Use [ Time Frame: Baseline, 3 and 6 months ]
    Client Service Receipt Inventory

  5. Health Related Quality of Life [ Time Frame: Baseline, 3 and 6 months ]
    Euroqol- 5D-5L

  6. Pain Free Walking Ability [ Time Frame: Baseline and 3 months ]
    Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test

  7. Maximal Walking Ability [ Time Frame: Baseline and 3 months ]
    The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥50 years of age;
  • established PAD (Ankle Brachial Pressure Index ≤0.90 and/or radiographic evidence) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238222


Contacts
Contact: Julie S Bieles, PhD 02078486321 julie.s.bieles@kcl.ac.uk
Contact: Lindsay Bearne, PhD 0207 848 6283 lindsay.bearne@kcl.ac.uk

Locations
United Kingdom
Dartford and Gravesham NHS Trust (GSTT PIC site) Recruiting
Dartford, Kent, United Kingdom
Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site) Recruiting
Maidstone, Kent, United Kingdom
Ashford & St Peter's NHS Foundation Trust Recruiting
Ashford, Surrey, United Kingdom
Guy's & St Thomas NHS Foundation Trust Recruiting
London, United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom
Lewisham and Greenwich NHS Trust (GSTT PIC site) Recruiting
London, United Kingdom
Oxleas NHS Foundation Trust (GSTT PIC site) Recruiting
London, United Kingdom
St George's University Hospital NHS Foundation Trust Recruiting
London, United Kingdom
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
The Dunhill Medical Trust
Investigators
Principal Investigator: Sanjay Patel Guy's and St Thomas' NHS Foundation Trust

Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03238222     History of Changes
Other Study ID Numbers: 17/LO/0568
R477/0516 ( Other Grant/Funding Number: Dunhill Medical Trust )
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Walking
Six-Minute Walk Distance
Illness Perceptions
Theory of Planned Behaviour

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms