CRF-QoL: Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure
Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04236726
Collaborator
(none)
200
1
27.4
7.3
Study Details
Study Description
Brief Summary
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure
Actual Study Start Date
:
Dec 19, 2019
Anticipated Primary Completion Date
:
Dec 31, 2021
Anticipated Study Completion Date
:
Apr 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Non-invasive ventilation Users of non-invasive ventilation |
Other: Questionnaire
HRQoL questionnaires
|
| Long term tracheostomy ventilation Long term tracheostomy ventilated patients |
Outcome Measures
Primary Outcome Measures
- HRQoL score [Day 0: At the first outpatient clinical consultation with the clinical team]
Outcome of various HRQoL assessment tools.
Secondary Outcome Measures
- Change in HRQoL score [6 months following first assessment for Outcome 1]
Change in HRQoL assessment tool score at next clinical follow-up.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Diagnosed with chronic respiratory failure receiving any of:
-
Non-invasive ventilation
-
Prolonged mechanical ventilation
-
Mechanical insufflation-exsufflation therapy
Exclusion Criteria:
-
Aged <18
-
Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guy's and St. Thomas NHS Foundation Trust | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
Investigators
- Study Chair: Patrick Murphy, MBBS, Guy's and St Thomas' NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT04236726
Other Study ID Numbers:
- CRF-QoL
First Posted:
Jan 22, 2020
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: