SELF - BREATHE for Chronic Breathlessness

A Self -Guided, Internet -Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): an Interview Study.

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cancer; COPD; Dyspnea; Interstitial Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Chronic Breathlessness	Other: Qualitative research interviews to be conducted; None. Qualitative research interviews to be conducted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): November 11, 2020
• Study Completion (Actual): November 11, 2020

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: KCH20-056; ICA-CL-2018-04-ST2-001 (Other Grant/Funding Number: HEE/NIHR Integrated Clinical Academic Programme)

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