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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT04236726
- Acronym / sponsor ID
- CRF-QoL / CRF-QoL
- Conditions
- Chronic Obstructive Pulmonary Disease, Respiratory Failure, Neuromuscular Diseases, Ventilatory Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.
Detailed description
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive ventilation | – | Other: QuestionnaireUsers of non-invasive ventilation |
| Long term tracheostomy ventilation | – | –Long term tracheostomy ventilated patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic respiratory failure being treated with a form of ventilation of mechanical insufflation-exsufflation therapy.
Key inclusion criteria (4 listed)
- Non-invasive ventilation
- Prolonged mechanical ventilation
- Mechanical insufflation-exsufflation therapy
Key exclusion criteria (2 listed)
- Aged <18
- Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireHRQoL questionnaires | Other | Non-invasive ventilation |
Primary outcome
HRQoL score
Time frame: Day 0: At the first outpatient clinical consultation with the clinical team
Outcome of various HRQoL assessment tools.
1 secondary outcome
Change in HRQoL score
Time frame: 6 months following first assessment for Outcome 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Murphy, MBBS study chair
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neeraj Shah, MBBS (+442071888070, neeraj.shah@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL score (time frame: Day 0: At the first outpatient clinical consultation with the clinical team). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.