Investigating a Well-being Review in Pulmonary Hypertension

NCT04840251 | Withdrawn

• 1 other identifier: STH20898
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmnary Hypertension

Outcome Measures

Primary Outcomes (1)

• 6MWD

  Change from Baseline in how far he patient can walk in 6 minutes

  Follow up at 6 months

Study Arms (3)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group will have initial assessments then receive brief advice on exercise. They will also be followed up after 6 months

Qualitative

OTHER

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

Interventions

Well-being review and rehabiliation OTHER

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.

Intervention

Qualitative Interviews OTHER

Patients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had

Qualitative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Sospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 9, 2021
• Study Start: March 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: May 1, 2023
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)