Investigating a Well-being Review in Pulmonary Hypertension

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmnary Hypertension
• Intervention / Treatment: Other: Well-being review and rehabiliation; Other: Qualitative Interviews

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S10 2JF
    • Sheffield Teaching Sospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.
No Intervention: Control; The control group will have initial assessments then receive brief advice on exercise. They will also be followed up after 6 months
Other: 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWD	Change from Baseline in how far he patient can walk in 6 minutes	Follow up at 6 months

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: STH20898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No