SELF - BREATHE for Chronic Breathlessness

Sponsor
King's College Hospital NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04466020
Collaborator
King's College London (Other)
25
1
5.3
4.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Qualitative research interviews to be conducted

Detailed Description

STUDY OVERVIEW

Full title:

A self -guided, internet -based intervention for patients with chronic breathlessness (SELF-BREATHE): an interview study.

Objective:

To understand the key factors that would enable / facilitate patients with chronic breathlessness to use an online breathlessness support intervention (SELF-BREATHE).

Study type:

Qualitative interview study

Methods:

Semi-structured qualitative interviews will be conducted to achieve maximum variation in approx 20 patients with chronic breathlessness (a purposive sample: age sex, diagnoses, and presence of caregiver).

The interview will explore and identify:

Patients' views/experiences of internet-based activities, e.g. digital apps, shopping online; Patients' understanding, preferences, values and motivations that would influence uptake of SELF-BREATHE; Potential barriers to the development and use of SELF-BREATHE; Facilitators to usage of SELF-BREATHE, such as the ability to self-monitor progress etc...

These topics cover areas of uncertainty in order to optimise the SELF - BREATHE intervention.

Inclusion criteria:

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 dysponea 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

Exclusion criteria:

Breathlessness of unknown cause

A primary diagnosis of chronic hyperventilation syndrome

Study Design

Study Type:
Observational
Actual Enrollment :
25 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Self -Guided, Internet -Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): an Interview Study.
Actual Study Start Date :
Jun 3, 2020
Actual Primary Completion Date :
Nov 11, 2020
Actual Study Completion Date :
Nov 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients with Chronic Breathlessness

Patients with Chronic Breathlessness

Other: Qualitative research interviews to be conducted
None. Qualitative research interviews to be conducted

Outcome Measures

Primary Outcome Measures

  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). [12 months]

    Qualitative data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Breathlessness of unknown cause

  • A primary diagnosis of chronic hyperventilation syndrome

Contacts and Locations

Locations

Site City State Country Postal Code
1 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS

Sponsors and Collaborators

  • King's College Hospital NHS Trust
  • King's College London

Investigators

  • Principal Investigator: Charles C Reilly, PhD,MSc,BSc, King's College Hospital NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT04466020
Other Study ID Numbers:
  • KCH20-056
  • ICA-CL-2018-04-ST2-001
First Posted:
Jul 10, 2020
Last Update Posted:
Sep 2, 2021
Last Verified:
Sep 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:

Study Results

No Results Posted as of Sep 2, 2021