Chronic Obstructive Pulmonary DiseaseCRF-QoLNCT04236726
Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure
An observational study of Chronic Obstructive Pulmonary Disease and Respiratory Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Respiratory Failure, Neuromuscular Diseases
- What is being tested?
- Questionnaire
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2019to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic respiratory failure being treated with a form of ventilation of mechanical insufflation-exsufflation therapy.
Who may be able to join
- Diagnosed with chronic respiratory failure receiving any of:
- Non-invasive ventilation
- Prolonged mechanical ventilation
- Mechanical insufflation-exsufflation therapy
Who cannot join
- Aged <18
- Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St. Thomas NHS Foundation Trust
London, SE1 7EH
Neeraj Shah, neeraj.shah@gstt.nhs.uk
Gill Arbane, gill.arbane@gstt.nhs.uk
About this study
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.
Read the detailed description
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
- Being tested
- Questionnaire
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Neuromuscular Diseases, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
HRQoL questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive ventilation | Users of non-invasive ventilation Receives: Other: Questionnaire | |
| Long term tracheostomy ventilation | Long term tracheostomy ventilated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL score
Outcome of various HRQoL assessment tools.
Measured: Day 0: At the first outpatient clinical consultation with the clinical team
Secondary outcomes (1)
Change in HRQoL score
Change in HRQoL assessment tool score at next clinical follow-up.
Measured: 6 months following first assessment for Outcome 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start19 Dec 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Murphy, MBBS, Study chair, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236726
- Sponsor's protocol ID
- CRF-QoL
- Acronym
- CRF-QoL
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2019
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No