Condition category
Circulatory System
Date applied
31/07/2017
Date assigned
02/08/2017
Last edited
02/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
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.

Who can participate?
Adults aged 50 years or older who have IC

What does the study involve?
Participants a study visit 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 are then randomly allocated to one of two groups. Those in the first group receive the new treatment which 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 to discuss participants’ understanding and beliefs about IC, walking and help participants to set goals and plans to increase walking over 12 weeks. Participants are provided with a step counter (pedometer) and walking record. Those in the second group receive their normal care. After 12 weeks, all participants attend a second appointment where they will repeat the walking tests and fill out another set of questionnaires. A final set of questionnaires are 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.

What are the possible benefits and risks of participating?
Participants may benefit from receiving consultations with a physiotherapist, and receiving a step counter and walking diary which can help them increase their walking ability. Participants may benefit from completing a walk test and learning about their own walking ability and walking as a treatment for intermittent claudication. Participants who engage in the walking activity may experience an increase in pain or discomfort. The treatment involves education and reassurance that these symptoms are unpleasant but do not indicate harm.

Where is the study run from?
Guy’s Hospital (UK)

When is the study starting and how long is it expected to run for?
July 2017 to July 2020

Who is funding the study?
The Dunhill Medical Trust (UK)

Who is the main contact?
Dr Melissa Galea Holmes
melissa.galea_holmes@kcl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Melissa Galea Holmes

ORCID ID

http://orcid.org/0000-0001-8796-4379

Contact details

King’s College London
The School of Population Sciences and Health Services Research
Faculty of Life Sciences & Medicine
Guy’s Campus
London
SE1 1UL
United Kingdom
+44 2078486321
melissa.galea_holmes@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34022

Study information

Scientific title

A brief physiotherapist-led behaviour-change intervention to facilitate walking in older people with peripheral arterial disease: A randomised controlled trial

Acronym

Study hypothesis

The aim of this study is to answer the questions:
1. Does MOSAIC improve walking ability (measured by the 6 Minute Walking Distance [6MWD]) at 3 months compared to usual NHS care in older people with intermittent claudication (IC)?
2. Does MOSAIC improve activities of daily living and QoL at 3 months and walking ability, activities of daily living and QoL at 6 months compared to usual NHS care in people with IC?
3. Is it feasible to collect the measures required to estimate cost utility in future phase 3 trials in people with IC?
4. What are the Mean Clinically Important Difference (MCID) thresholds for the assessment measures in this population?

Ethics approval

London-Bloomsbury Research Ethics Committee, 27/04/2017, 17/LO/0568

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Physical, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cardiovascular disease, Primary sub-specialty: Atherothrombosis; UKCRC code/ Disease: Cardiovascular/ Diseases of arteries, arterioles and capillaries

Intervention

Participants visit the study site 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.

Following informed consent and completion of the baseline assessment, the participant is randomised to one of two arms. Participants are randomised at the level of the individual, stratified within recruitment site, to receive either MOSAIC plus usual NHS care or usual NHS care alone in a ratio of 1:1. The King's College London Clinical Trials Unit provides randomisation. The system is online and can be accessed 24 hours a day. The RA logs in, enter key information about the participant, and the randomisation allocation occurs instantly. Confirmation emails are generated automatically and sent to the CI (and delegated members of the research team) and trial physiotherapists delivering MOSAIC. The RA, who is the outcome assessor, is blind to group allocation. Once the participant is randomised they are given a unique trial identifying number.

Arm 1 MOSAIC Treatment: Participants in this group receive two 60-minute individual face-to-face consultations ( on weeks one & two) and two 20-minute follow-up telephone calls (weeks six & 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. A checklist outlining the components for each session is provided to each physiotherapist. All participants randomized to this arm are provided with a pedometer and a patient manual which include information on intermittent claudication (IC), risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary.

Arm 2 Usual Care comparison: Participants randomized to the comparison group continue to receive usual NHS care for intermittent claudication which 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.

After 12 weeks, all participants attend a second appointment where they will repeat the walking tests and fill out another set of questionnaires. A final set of questionnaires are completed by all participants after 6 months (by post or electronically). Some participants are invited to provide feedback on their experience of the treatment and trial by telephone or a face-to-face interview with a researcher.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The 6 Minute Walking Distance (in metres) at 3 months is measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.

Secondary outcome measures

1. Pain-free and maximal walking ability measured during a 6 Minute Walk Test at baseline, 3 and 6 months
2. Self-reported maximal walking distance measured by a global single-item at baseline, 3 and 6 months
3. Self-reported walking ability measured by the Walking Estimated-Limitation Calculated by History [WELCH] questionnaire at baseline, 3 and 6 months
4. Activities of Daily Living measured by the Nottingham Extended Activities of Daily Living [NEADL] questionnaire at baseline, 3 and 6 months
5. Quality of Life measured by the Vascular Quality of Life Questionnaire-6 [VascuQol-6] at baseline, 3 and 6 months

Process and feasibility outcomes:
1. Treatment cognitions measured by a Theory of Planned Behaviour Questionnaire (TPBQ) at baseline, 3 and 6 months
2. Illness cognitions measured by the Brief Illness Perceptions Questionnaire (BIPQ) at baseline, 3 and 6 months
3. Walking adherence measured by the Exercise Adherence Rating Scale (EARS) at baseline, 3 and 6 months
4. Resource use measured by the Client Services Receipt Inventory at baseline 3 and 6 months
5. Quality of Life measured by the EuroQuol 5D-5L (EQ-5D-5L) at baseline 3 and 6 months

Overall trial start date

10/07/2017

Overall trial end date

09/07/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. ≥50 years of age
2. Established PAD (Ankle Brachial Pressure Index ≤0.90 and/or radiographic evidence) and IC (presence of symptoms reported on the San Diego Claudication Questionnaire (SDCQ))
3. Able to participate in MOSAIC
4. Able and willing to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 192; UK Sample Size: 192

Participant exclusion criteria

1. Unstable IC (self-reported change in symptoms in previous 3 months)
2. Walking more than 90 minutes per week (reported via Brief International Physical Activity Questionnaire
3. Contraindications to walking exercise (e.g. unstable angina) confirmed by their vascular specialist
4. Have completed any prescribed exercise sessions in the previous 6 months or been offered prescribed exercise sessions in the next 6 months.

Recruitment start date

10/10/2017

Recruitment end date

09/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy’s Hospital
Guy’s & St Thomas’ NHS Foundation Trust Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Research Management & Innovation Directorate
K0.58 King’s Building
Strand Campus
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

Organisation

Guy’s & St Thomas’ NHS Foundation Trust

Sponsor details

R&D Department
16th Floor
Tower Wing
Guy’s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Dunhill Medical Trust

Alternative name(s)

DMT

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal, anticipated October 2021.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/10/2021

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes