Investigating Health Related Quality of Life in Patients... | NCT04236726

Studies
Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure

NCT04236726

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Status

Recruiting

Last Update Posted

Jun 4, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease
Respiratory Failure
Neuromuscular Diseases
Ventilatory Failure

Interventions

Questionnaire

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2019Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 17, 2019

First Submission Date that Met QC Criteria

Jan 21, 2020

First Posted Date

Jan 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2026

Last Update Posted Date

Jun 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-invasive ventilation		Users of non-invasive ventilation	Other: Questionnaire
Long term tracheostomy ventilation		Long term tracheostomy ventilated patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	HRQoL questionnaires	Non-invasive ventilation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Neeraj Shah, MBBS	Contact	+442071888070		neeraj.shah@gstt.nhs.uk
Patrick Murphy, MBBS	Contact	+442071888070		patrick.murphy@gstt.nhs.uk

Overall Officials

Name	Affiliation	Role
Patrick Murphy, MBBS	Guy's and St Thomas' NHS Foundation Trust	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guy's and St. Thomas NHS Foundation Trust	Recruiting	London		SE1 7EH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D012131	Respiratory Insufficiency
D009468	Neuromuscular Diseases
D007040	Hypoventilation

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided