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Motivating Structured Walking Activity in Intermittent Claudication (MOSAIC)

10. december 2019 opdateret af: Guy's and St Thomas' NHS Foundation Trust

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

192

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
        • Rekruttering
        • King's College Hospital NHS Foundation Trust
      • London, Det Forenede Kongerige
        • Rekruttering
        • Royal Free London NHS Foundation Trust
      • London, Det Forenede Kongerige
        • Rekruttering
        • Guy's & St Thomas NHS Foundation Trust
      • London, Det Forenede Kongerige
        • Rekruttering
        • Lewisham and Greenwich NHS Trust (GSTT PIC site)
      • London, Det Forenede Kongerige
        • Rekruttering
        • St George's University Hospital NHS Foundation Trust
      • London, Det Forenede Kongerige
        • Rekruttering
        • The Royal London Hospital, Barts Heatth NHS Trust
    • Kent
      • Dartford, Kent, Det Forenede Kongerige
        • Rekruttering
        • Dartford and Gravesham NHS Trust (GSTT PIC site)
      • Maidstone, Kent, Det Forenede Kongerige
        • Rekruttering
        • Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
    • Surrey
      • Ashford, Surrey, Det Forenede Kongerige
        • Rekruttering
        • Ashford & St Peter's NHS Foundation Trust

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • Motivating Structured walking Activity in IC
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6 Minute Walk Distance
Tidsramme: 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.
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6 Minute Walk Distance (6MWD)
Tidsramme: 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.
Baseline and 3 months
Self-reported Maximum Walking Distance
Tidsramme: Baseline, 3 and 6 months
Single global item
Baseline, 3 and 6 months
Self-Reported Walking Ability
Tidsramme: Baseline, 3 and 6 months
Walking Estimated-Limitation Calculated by History (WELCH)
Baseline, 3 and 6 months
Activities of Daily Living
Tidsramme: Baseline, 3 and 6 months
Nottingham Extended Activities of Daily Living (NEADL)
Baseline, 3 and 6 months
Health-Related Quality of Life
Tidsramme: Baseline, 3 and 6 months
Vascular Quality of Life Questionnaire-6 (VascuQol-6)
Baseline, 3 and 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Cognitions
Tidsramme: Baseline, 3 and 6 months
Theory of Planned Behaviour Questionnaire
Baseline, 3 and 6 months
Illness Cognitions
Tidsramme: Baseline, 3 and 6 months
Brief Illness Perceptions Questionnaire (BIPQ)
Baseline, 3 and 6 months
Walking Adherence
Tidsramme: Baseline, 3 and 6 months
Exercise Adherence Rating Scale
Baseline, 3 and 6 months
Resource Use
Tidsramme: Baseline, 3 and 6 months
Client Service Receipt Inventory
Baseline, 3 and 6 months
Health Related Quality of Life
Tidsramme: Baseline, 3 and 6 months
Euroqol- 5D-5L
Baseline, 3 and 6 months
Pain Free Walking Ability
Tidsramme: Baseline and 3 months
Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test
Baseline and 3 months
Maximal Walking Ability
Tidsramme: Baseline and 3 months
The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test
Baseline and 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Samarbejdspartnere

King's College London
The Dunhill Medical Trust

Efterforskere

  • Ledende efterforsker: Sanjay Patel, Guy's and St Thomas' NHS Foundation Trust

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. november 2017

Primær færdiggørelse (Forventet)

9. november 2020

Studieafslutning (Forventet)

9. januar 2021

Datoer for studieregistrering

Først indsendt

1. august 2017

Først indsendt, der opfyldte QC-kriterier

1. august 2017

Først opslået (Faktiske)

3. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 17/LO/0568
  • R477/0516 (Andet bevillings-/finansieringsnummer: Dunhill Medical Trust)

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

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