Motivating Structured Walking Activity in Intermittent Claudication (MOSAIC)

Guy's and St Thomas' NHS Foundation Trust

Status: Unknown

Conditions: Peripheral Vascular Disease; Intermittent Claudication; Peripheral Arterial Disease

Treatments: Behavioral: MOSAIC

Study type: Interventional

Funder types: Other

Identifiers

NCT03238222

R477/0516 (Other Grant/Funding Number)

17/LO/0568

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups

MOSAIC Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: MOSAIC

Usual Care Comparison

No Intervention group

Description:

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.