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
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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.
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- Received September 30, 2022.
- Accepted December 17, 2022.
- Copyright ©The authors 2023
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