Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure (CRF-QoL)

April 2, 2024 updated by: Guy's and St Thomas' NHS Foundation Trust
To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-invasive ventilation
Users of non-invasive ventilation
Other: Questionnaire
HRQoL questionnaires
Long term tracheostomy ventilation
Long term tracheostomy ventilated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRQoL score
Time Frame: Day 0: At the first outpatient clinical consultation with the clinical team
Outcome of various HRQoL assessment tools.
Day 0: At the first outpatient clinical consultation with the clinical team

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HRQoL score
Time Frame: 6 months following first assessment for Outcome 1
Change in HRQoL assessment tool score at next clinical follow-up.
6 months following first assessment for Outcome 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Study Chair: Patrick Murphy, MBBS, Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2019

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRF-QoL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe