Motivating Structured Walking Activity in Intermittent Claudication (MOSAIC)
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|ClinicalTrials.gov Identifier: NCT03238222|
Recruitment Status : Not yet recruiting
First Posted : August 3, 2017
Last Update Posted : August 4, 2017
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|
|Peripheral Arterial Disease Intermittent Claudication Peripheral Vascular Disease||Behavioral: MOSAIC|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial|
|Anticipated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||April 2020|
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.
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.
- 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.
- 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.
- Self-reported Maximum Walking Distance [ Time Frame: Baseline, 3 and 6 months ]Single global item
- Self-Reported Walking Ability [ Time Frame: Baseline, 3 and 6 months ]Walking Estimated-Limitation Calculated by History (WELCH)
- Activities of Daily Living [ Time Frame: Baseline, 3 and 6 months ]Nottingham Extended Activities of Daily Living (NEADL)
- Health-Related Quality of Life [ Time Frame: Baseline, 3 and 6 months ]Vascular Quality of Life Questionnaire-6 (VascuQol-6)
- Treatment Cognitions [ Time Frame: Baseline, 3 and 6 months ]Theory of Planned Behaviour Questionnaire
- Illness Cognitions [ Time Frame: Baseline, 3 and 6 months ]Brief Illness Perceptions Questionnaire (BIPQ)
- Walking Adherence [ Time Frame: Baseline, 3 and 6 months ]Exercise Adherence Rating Scale
- Resource Use [ Time Frame: Baseline, 3 and 6 months ]Client Service Receipt Inventory
- Health Related Quality of Life [ Time Frame: Baseline, 3 and 6 months ]Euroqol- 5D-5L
- 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
- 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
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
|Contact: Melissa N Galea Holmes, PhDemail@example.com|
|Contact: Lindsay Bearne, PhD||0207 848 firstname.lastname@example.org|
|Principal Investigator:||Sanjay Patel||Guy's and St Thomas' NHS Foundation Trust|