NCT04466020

Brief Summary

Semi-structured qualitative interviews will be conducted to understand key factors that would enable / facilitate patients with chronic breathlessness to potentially use an online breathlessness intervention (SELF-BREATHE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 3, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

July 7, 2020

Last Update Submit

September 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Descriptive qualitative analysis of patients' preferences, values and motivations that would influence the use of an online self - management intervention for chronic breathlessness (SELF-BREATHE).

    Qualitative data

    12 months

Study Arms (1)

Patients with Chronic Breathlessness

Patients with Chronic Breathlessness

Other: Qualitative research interviews to be conducted

Interventions

None. Qualitative research interviews to be conducted

Patients with Chronic Breathlessness

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD, Cancer, Heart Failure, Interstitial Lung disease, Dyspnea

You may qualify if:

  • Adult patients \>18 years of age, with the ability to read, converse in English and able to provide informed consent
  • Chronic breathlessness on exertion and or rest (MRC dyspnea score \>2)
  • Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to be optimally medically managed by the referring clinician / allied health professional / clinical nurse specialist

You may not qualify if:

  • Breathlessness of unknown cause
  • A primary diagnosis of chronic hyperventilation syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveNeoplasmsHeart FailureDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Charles C Reilly, PhD,MSc,BSc

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 10, 2020

Study Start

June 3, 2020

Primary Completion

November 11, 2020

Study Completion

November 11, 2020

Last Updated

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations