NCT04236726

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

December 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

5.3 years

First QC Date

December 17, 2019

Last Update Submit

April 2, 2024

Conditions

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

HRQoL questionnaires

Non-invasive ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St. Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory InsufficiencyNeuromuscular DiseasesHypoventilation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment 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

Patrick Murphy, MBBS

CONTACT

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

March 31, 2025

Study Completion

May 31, 2025

Last Updated

April 3, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations