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Motivating Structured Walking Activity in Intermittent Claudication (MOSAIC)

10. desember 2019 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

192

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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 navn:
  • Motivating Structured walking Activity in IC
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Samarbeidspartnere

King's College London
The Dunhill Medical Trust

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

10. november 2017

Primær fullføring (Forventet)

9. november 2020

Studiet fullført (Forventet)

9. januar 2021

Datoer for studieregistrering

Først innsendt

1. august 2017

Først innsendt som oppfylte QC-kriteriene

1. august 2017

Først lagt ut (Faktiske)

3. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. desember 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. desember 2019

Sist bekreftet

1. desember 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 17/LO/0568
  • R477/0516 (Annet stipend/finansieringsnummer: Dunhill Medical Trust)

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