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A randomised, controlled, feasibility trial of an online, self-guided breathlessness supportive intervention (SELF-BREATHE) for individuals with chronic breathlessness due to advanced disease

Charles C Reilly, Matthew Maddocks, Trudie Chalder, Katherine Bristowe, Irene J Higginson
ERJ Open Research 2023; DOI: 10.1183/23120541.00508-2022
Charles C Reilly
1Department of Physiotherapy, King's College Hospital, London, UK
2Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, UK
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  • ORCID record for Charles C Reilly
  • For correspondence: charles.c.reilly@kcl.ac.uk charles.reilly@nhs.net
Matthew Maddocks
2Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, UK
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Trudie Chalder
3King's College London, Institute of Psychiatry, Department of Psychological Medicine, London, UK
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Katherine Bristowe
2Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, UK
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Irene J Higginson
2Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, UK
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Abstract

Introduction SELF-BREATHE is a complex, transdiagnostic, supportive, digital breathlessness intervention co-developed with patients. SELF-BREATHE seeks to build capacity and resilience within health services by improving the lives of people with chronic breathlessness using nonpharmacological, self-management approaches. This study aimed to determine whether SELF-BREATHE is feasible to deliver and acceptable to patients living with chronic breathlessness.

Methods Design: A parallel, two arm, single blind, single centre, randomised controlled mixed-methods feasibility trial with participants allocated to 1) intervention group (SELF-BREATHE) or 2) control group (usual NHS care).

Setting Large multisite NHS Foundation Trust in Southeast London.

Participants Patients living with chronic breathlessness due to advanced malignant or non-malignant disease(s).

Intervention Participants were randomly allocated (1:1) to an online, self-guided, breathlessness, supportive intervention (SELF-BREATHE) and usual care or usual care alone, over six weeks.

A priori progression criteria ≥30% of eligible patients given an information sheet consented to participate,≥60% of participants logged on and accessed SELF–BREATHE within 2 weeks, ≥70% of patients reported the methodology and intervention as acceptable.

Results Between January 2021 and January 2022, 52/110 (47%) eligible patients consented and were randomised. Of those randomised to SELF-BREATHE, 19/26 (73%) logged on and used SELF-BREATHE for a mean (sd, range) of 9 (8, 1–33) times over 6-weeks. Thirty-six of the 52 (70%) randomised participants completed and returned the end of study postal questionnaires. SELF-BREATHE users reported it to be acceptable. Post intervention qualitative interviews demonstrated that SELF-BREATHE was acceptable and valued, by users, improving breathlessness during daily life and at points of breathlessness crisis.

Conclusion These data support the feasibility of moving to a fully powered, efficacy, randomised controlled trial with minor modifications to minimise missing data (i.e., multiple methods for data collection, face-to-face, telephone, video assessment and via post).

Footnotes

This manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.

Conflict of interest: Charles C Reilly received support for the present manuscript from NIHR; funding received from King's Together and Royal Brompton Hospital – King's Health Partnership Transformation, outside the submitted work.

Conflict of interest: Irene Higginson has received grants or contracts from NIHR, UKRI, Cicely Saunders International, and Marie Curie, outside the submitted work.

Conflict of interest: Trudie Chalder receives salary support from the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London (KCL). The views expressed in this article are those of the authors and not necessarily those of the NIHR or the NHS.

Conflict of interest: Matthew Maddocks has received grants or contracts from National Institute for Health Research (NIHR) Career Development Fellowship (CDF-2017–10-009), and NIHR Applied Research Collaboration South London (NIHR ARC South London) at King's College Hospital NHS Foundation Trust, outside the submitted work.

Conflict of interest: Katherine Bristowe has received grants or contracts from National Institute for Health Research, Medical Research Council, Health Education England, European Commission, and Marie Curie, outside the submitted work.

This is a PDF-only article. Please click on the PDF link above to read it.

  • Received September 30, 2022.
  • Accepted December 17, 2022.
  • Copyright ©The authors 2023
http://creativecommons.org/licenses/by-nc/4.0/

This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions{at}ersnet.org

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A randomised, controlled, feasibility trial of an online, self-guided breathlessness supportive intervention (SELF-BREATHE) for individuals with chronic breathlessness due to advanced disease
Charles C Reilly, Matthew Maddocks, Trudie Chalder, Katherine Bristowe, Irene J Higginson
ERJ Open Research Jan 2023, 00508-2022; DOI: 10.1183/23120541.00508-2022

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A randomised, controlled, feasibility trial of an online, self-guided breathlessness supportive intervention (SELF-BREATHE) for individuals with chronic breathlessness due to advanced disease
Charles C Reilly, Matthew Maddocks, Trudie Chalder, Katherine Bristowe, Irene J Higginson
ERJ Open Research Jan 2023, 00508-2022; DOI: 10.1183/23120541.00508-2022
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