Peripheral Arterial DiseaseMOSAICNCT03238222
Motivating Structured Walking Activity in Intermittent Claudication
A study testing MOSAIC in people with Peripheral Arterial Disease and Intermittent Claudication, run by Guy's and St Thomas' NHS Foundation Trust at 9 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication, Peripheral Vascular Disease
- What is being tested?
- MOSAIC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 10 Nov 2017to 9 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites, 9 recruiting
- Recruiting
Ashford & St Peter's NHS Foundation Trust
Ashford, Surrey
- Recruiting
Dartford and Gravesham NHS Trust (GSTT PIC site)
Dartford, Kent
- Recruiting
Guy's & St Thomas NHS Foundation Trust
London
- Recruiting
King's College Hospital NHS Foundation Trust
London
- Recruiting
Lewisham and Greenwich NHS Trust (GSTT PIC site)
London
- Recruiting
Royal Free London NHS Foundation Trust
London
- Recruiting
St George's University Hospital NHS Foundation Trust
London
- Recruiting
The Royal London Hospital, Barts Heatth NHS Trust
London
- Recruiting
Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
Maidstone, Kent
About this study
Official title: 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.
- Being tested
- MOSAIC
- Keywords
- Walking, Six-Minute Walk Distance, Illness Perceptions, Theory of Planned Behaviour
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOSAICBehavioural
Also called Motivating Structured walking Activity in IC
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.
| Study group | Role | What they receive |
|---|---|---|
| MOSAIC Treatment | Experimental | 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. Receives: Behavioral: MOSAIC |
| Usual Care Comparison | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: Baseline and 3 months
Self-reported Maximum Walking Distance
Single global item
Measured: Baseline, 3 and 6 months
Self-Reported Walking Ability
Walking Estimated-Limitation Calculated by History (WELCH)
Measured: Baseline, 3 and 6 months
Activities of Daily Living
Nottingham Extended Activities of Daily Living (NEADL)
Measured: Baseline, 3 and 6 months
Health-Related Quality of Life
Vascular Quality of Life Questionnaire-6 (VascuQol-6)
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start10 Nov 2017
- Primary completion9 Nov 2020 (estimated)
- Study completion9 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, The Dunhill Medical Trust
- Responsible party
- Sponsor
- Investigators
- Sanjay Patel, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238222
- Sponsor's protocol ID
- 17/LO/0568
- Other IDs
- R477/0516
- Acronym
- MOSAIC
- Status last verified
- Dec 2019
- First submitted
- 1 Aug 2017
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35412564
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03238222
- Acronym / sponsor ID
- MOSAIC / 17/LO/0568
- Keywords
- Walking, Six-Minute Walk Distance, Illness Perceptions, Theory of Planned Behaviour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, The Dunhill Medical Trust
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 9 Nov 2020 (estimated)
- Study completion
- 9 Jan 2021 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOSAIC Treatment | Experimental | Behavioral: MOSAICMOSAIC 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. |
| Usual Care Comparison | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOSAICAlso: Motivating Structured walking Activity in ICMOSAIC 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. | Behavioural | MOSAIC Treatment |
Primary outcome
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.
5 secondary outcomes
6 Minute Walk Distance (6MWD)
Time frame: Baseline and 3 months
Self-reported Maximum Walking Distance
Time frame: Baseline, 3 and 6 months
Self-Reported Walking Ability
Time frame: Baseline, 3 and 6 months
Activities of Daily Living
Time frame: Baseline, 3 and 6 months
Health-Related Quality of Life
Time frame: Baseline, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Derived from this study: PubMed 35412564Bearne 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.
- Individual participant dataSharing planned: Undecided
Related trials for Peripheral Arterial Disease
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Patel principal investigator
Guy's and St Thomas' NHS Foundation Trust
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOSAIC in people with Peripheral Arterial Disease and Intermittent Claudication, run by Guy's and St Thomas' NHS Foundation Trust at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie S Bieles, PhD (02078486321, julie.s.bieles@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Distance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03238222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.