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Investigating a Well-being Review in Pulmonary Hypertension

8. april 2021 oppdatert av: Sheffield Teaching Hospitals NHS Foundation Trust

Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.

Pulmonary Hypertension (PH) is a rare disease that makes patients easily become breathless. There is evidence that people with PH can benefit from exercise; we want to look at how they can access rehabilitation in their local community.

Aim: To see if it is feasible to study physiotherapy well-being reviews in PH. Step 1: We will interview some patients with PH who have had rehabilitation and ask questions about their experiences. We will also ask what they think we should measure to show any difference their rehabilitation has made to them. The findings from Step 1 will help us to shape the details of Step 2, where we will conduct a small study to see if it is feasible to run a full study. Participants will be divided randomly into a treatment group and a control group. The treatment group will have a physiotherapy well-being review, leading to referral to their most suitable local rehabilitation service and follow-up after 6 months. The control group will receive brief exercise advice and follow-up after 6 months. The findings will help to design a full study and be shared with patients and health professionals.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

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
      • Sheffield, Storbritannia, S10 2JF
        • Sheffield Teaching Sospitals 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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • in World Health Organisation (WHO) Functional Class II or III
  • have a diagnosis of PH
  • have started on PH drug therapy in the preceding 18 months
  • showing no signs of worsening breathlessness or heart failure
  • on an unchanged PH therapeutic regime for at least 6 months prior to inclusion.

Exclusion Criteria:

  • have an active infection or acute exacerbation of lung disease
  • have participated in a clinical study involving another investigation of drug, device or exercise within the previous 6 months
  • are on a surgical or other pathway of care that has pre-determined physiotherapy or activity regimes or restrictions
  • have any additional medical conditions that may adversely affect the safety of the subject or severely limit the lifespan of the subject
  • have participated in rehabilitation in the last 12 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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
The treatment group will have a physiotherapy well-being review and be referred for rehabilitation. They will be seen after 6 months for follow-up
Annen: Well-being review and rehabiliation

For their well-being review, patients will meet with a physiotherapist specialist in PH and discuss:

  • how they are
  • what they can do for themselves
  • what it is challenging for them to do
  • how active they are
  • if they have ever exercised before The physiotherapist will then make a referral to the most suitable rehabilitation service local to the patient e.g. rehabilitation classes, physiotherapy at home, weight-loss programmes.
Ingen inngripen: Control
The control group will have initial assessments then receive brief advice on exercise. They will also be followed up after 6 months
Annen: Qualitative
to understand how it feels to take part in the well-being review, we will interview some participants who have already had this kind of treatment and ask questions about their experiences of it and how it was for them. We are also interested to know what differences they felt it made so that we can help to decide about the things we want to measure as outcomes in the interventional of the study.
Annen: Qualitative Interviews
Patients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6MWD
Tidsramme: Follow up at 6 months
Change from Baseline in how far he patient can walk in 6 minutes
Follow up at 6 months

Samarbeidspartnere og etterforskere

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

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. mars 2021

Primær fullføring (Forventet)

1. oktober 2022

Studiet fullført (Forventet)

1. mai 2023

Datoer for studieregistrering

Først innsendt

23. mars 2021

Først innsendt som oppfylte QC-kriteriene

8. april 2021

Først lagt ut (Faktiske)

9. april 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STH20898

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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