Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure

NCT04236726 | Recruiting DMC

• 1 other identifier: CRF-QoL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

Conditions

Chronic Obstructive Pulmonary Disease; Respiratory Failure; Neuromuscular Diseases; Ventilatory Failure

Outcome Measures

Primary Outcomes (1)

• HRQoL score

  Outcome of various HRQoL assessment tools.

  Day 0: At the first outpatient clinical consultation with the clinical team

Secondary Outcomes (1)

• Change in HRQoL score

  6 months following first assessment for Outcome 1

Study Arms (2)

Non-invasive ventilation

Users of non-invasive ventilation

Other: Questionnaire

Long term tracheostomy ventilation

Long term tracheostomy ventilated patients

Interventions

Questionnaire OTHER

HRQoL questionnaires

Non-invasive ventilation

Eligibility Criteria

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

Study Population

Patients with chronic respiratory failure being treated with a form of ventilation of mechanical insufflation-exsufflation therapy.

You may qualify if:

• Diagnosed with chronic respiratory failure receiving any of:
• Non-invasive ventilation
• Prolonged mechanical ventilation
• Mechanical insufflation-exsufflation therapy

You may not qualify if:

• Aged \<18
• Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St. Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Neuromuscular Diseases; Hypoventilation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Patrick Murphy, MBBS

  Guy's and St Thomas' NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Neeraj Shah, MBBS

CONTACT

+442071888070; neeraj.shah@gstt.nhs.uk

Patrick Murphy, MBBS

CONTACT

+442071888070; patrick.murphy@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 22, 2020
• Study Start: December 19, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)