TY - JOUR
T1 - A randomised, controlled, feasibility trial of an online, self-guided breathlessness supportive intervention (SELF-BREATHE) for individuals with chronic breathlessness due to advanced disease
AU - Reilly, Charles C.
AU - Maddocks, Matthew
AU - Chalder, Trudie
AU - Bristowe, Katherine
AU - Higginson, Irene J.
N1 - Funding Information:
Conflict of interest: C.C. Reilly received support for the present manuscript from the NIHR; and declares funding received from King’s Together and Royal Brompton Hospital – King’s Health Partnership Transformation, outside the submitted work. M. 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. T. 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. The views expressed in this article are those of the authors and not necessarily those of the NIHR or the NHS. K. Bristowe has received grants or contracts from the National Institute for Health Research, Medical Research Council, Health Education England, European Commission, and Marie Curie, outside the submitted work. I.J. Higginson has received grants or contracts from the NIHR, UKRI, Cicely Saunders International and Marie Curie, outside the submitted work.
Funding Information:
We thank all the patients who participated in this research, and everybody who identified and screened patients for this study, especially the respiratory medicine and physiotherapy departments at King’s College Hospital (London, UK).Support statement: A National Institute for Health and Care Research (NIHR) Clinical Lectureship (ICA-CL-2018-04-ST2-001) supports C.C. Reilly. M. Maddocks is supported by an NIHR Career Development Fellowship (CDF-2017-10-009). M. Maddocks and I.J. Higginson are supported by the NIHR Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. I.J. Higginson is an NIHR Senior Investigator Emeritus. This publication presents independent research funded by the NIHR. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, NIHR or the Dept of Health and Social Care. Funding information for this article has been deposited with the Crossref Funder Registry.
Funding Information:
Support statement: A National Institute for Health and Care Research (NIHR) Clinical Lectureship (ICA-CL-2018-04-ST2-001) supports C.C. Reilly. M. Maddocks is supported by an NIHR Career Development Fellowship (CDF-2017-10-009). M. Maddocks and I.J. Higginson are supported by the NIHR Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. I.J. Higginson is an NIHR Senior Investigator Emeritus. This publication presents independent research funded by the NIHR. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, NIHR or the Dept of Health and Social Care. Funding information for this article has been deposited with the Crossref Funder Registry.
Publisher Copyright:
© The authors 2023.
PY - 2023/3/1
Y1 - 2023/3/1
N2 - 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 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 National Health Service (NHS) care). The setting was a large multisite NHS foundation trust in south-east London, UK. The participants were patients living with chronic breathlessness due to advanced malignant or nonmalignant disease(s). Participants were randomly allocated (1:1) to an online, self-guided, breathlessness supportive intervention (SELF-BREATHE) and usual care or usual care alone, over 6 weeks. The a priori progression criteria were ⩾30% of eligible patients given an information sheet consented to participate; ⩾60% of participants logged on and accessed SELF-BREATHE within 2 weeks; and ⩾70% of patients reported the methodology and intervention as acceptable. Results Between January 2021 and January 2022, 52 (47%) out of 110 eligible patients consented and were randomised. Of those randomised to SELF-BREATHE, 19 (73%) out of 26 logged on and used SELF-BREATHE for a mean±SD (range) 9±8 (1–33) times over 6 weeks. 36 (70%) of the 52 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, randomised controlled efficacy trial with minor modifications to minimise missing data (i.e. multiple methods of data collection: face-to-face, telephone, video assessment and by post).
AB - 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 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 National Health Service (NHS) care). The setting was a large multisite NHS foundation trust in south-east London, UK. The participants were patients living with chronic breathlessness due to advanced malignant or nonmalignant disease(s). Participants were randomly allocated (1:1) to an online, self-guided, breathlessness supportive intervention (SELF-BREATHE) and usual care or usual care alone, over 6 weeks. The a priori progression criteria were ⩾30% of eligible patients given an information sheet consented to participate; ⩾60% of participants logged on and accessed SELF-BREATHE within 2 weeks; and ⩾70% of patients reported the methodology and intervention as acceptable. Results Between January 2021 and January 2022, 52 (47%) out of 110 eligible patients consented and were randomised. Of those randomised to SELF-BREATHE, 19 (73%) out of 26 logged on and used SELF-BREATHE for a mean±SD (range) 9±8 (1–33) times over 6 weeks. 36 (70%) of the 52 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, randomised controlled efficacy trial with minor modifications to minimise missing data (i.e. multiple methods of data collection: face-to-face, telephone, video assessment and by post).
UR - http://www.scopus.com/inward/record.url?scp=85156254512&partnerID=8YFLogxK
U2 - 10.1183/23120541.00508-2022
DO - 10.1183/23120541.00508-2022
M3 - Article
AN - SCOPUS:85156254512
SN - 2312-0541
VL - 9
JO - ERJ Open Research
JF - ERJ Open Research
IS - 2
M1 - 00508-2022
ER -