Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study

Gemma Pearce, Nikki Holliday, Harbinder Kaur Sandhu, Helen Eftekhari, Julie Bruce, Emma Timms, Laura Ablett, Lesley Kavi, Jane V. Simmonds, Rebecca Evans, Paul Magee, Richard Powell, Shane Keogh, Gordon McGregor

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Abstract

Background: There is a dearth of research to support the treatment of people with Postural Tachycardia Syndrome (PoTS). Despite expert consensus suggesting exercise is recommended for this patient group, there are no randomised control trials examining this rigorously. The aim was to co-create a feasibility trial protocol and a rehabilitation intervention for people living with PoTS.

Methods: The intervention and feasibility trial design were co-created as part of the PostUraL tachycardia Syndrome Exercise (PULSE) study. We used the ‘three co’s framework’ of co-define, co-design and co-refine. Recruitment included key national charities and National Health Service Trusts treating people living with PoTS in the United Kingdom.18 Patient and Public Involvement members attended the co-define session, and 16 co-creators with a mix of expertise attended the subsequent co-design and co-refine sessions. Seven intervention practitioners were trained in the rehabilitation intervention, providing feedback for further co-refinement.

Results: The final co-created intervention comprises online physical activity, and lifestyle and behaviour change support sessions. It is based on functional movement activities using a patient-centred approach tailored to individual needs. Physical activity intensity is guided by individuals’ perception of effort rather than by objective measures. Recumbent bikes are provided for home use. Patients deemed randomisation to be acceptable because research in this area was considered important.

Conclusions: An innovative approach was used to co-create the PULSE intervention and feasibility trial protocol to meet the evidence-based and logistical needs of people living with PoTS, clinicians, service deliverers, third sector organisations, academics and funders. This can be used as a successful example and template for future research internationally. People living with PoTS were recognised as experts and involved in every aspect of conceptualisation, design and refinement. This complex rehabilitation intervention is currently being tested in a randomised feasibility trial comparing the PULSE intervention with best-practice usual care for people living with PoTS.
Original languageEnglish
Article number143
Number of pages14
JournalPilot and Feasibility Studies
Volume9
Issue number1
DOIs
Publication statusPublished - 15 Aug 2023

Bibliographical note

This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data

Funder

The authors would like to thank our patient partners and all the stakeholders who took part in the co-creation of the PULSE intervention and trial protocol. We would also like to thank the study implementation, management and support teams at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust and Coventry University (CU), with special thanks to Shivam Joshi (Trial Manager, UHCW) and Gita Devi (Research Delivery Support Partner, CU). We would like to specifically acknowledge Tim Ablett as a PPI collaborator on the grant application and co-creators Hayley Kelly (PPI member), Trudie Lobban (Syncope Trust And Reflex Anoxic Seizures (STARS: Founder and CEO) and Arrhythmia Alliance), Melloney Ferrar (Syncope and POTS Nurse Specialist, Sheffield Teaching Hospitals Foundation Trust), Nigel Harris (Senior Physical Activity Specialist, Imperial College Healthcare NHS Trust), Rachael Harris (previous Patient Services Coordinator, STARS) and Joanne Bullingham (Charity Administrator, PoTS UK). Funding Information: We co-created a complex, theory-based and multicomponent intervention incorporating physical activity, lifestyle and behavioural support for people living with PoTS, to be tested within a randomised feasibility trial. This innovative, transparent and systematic approach showcases best practices as a successful example of how to fully apply iterative and person-centred co-creative processes to optimise intervention and feasibility trial protocol development. PPI was engaged throughout the development process alongside other key stakeholders, as part of the decision-making core team and co-creation activities. This study provides a success story of overcoming key barriers to PPI addressing the current international vision for research for 2025 []. Public awareness and communication were increased through the public research engagement hub of ‘hEDS together’ ( www.hEDStogether.com ) and the related charities of PoTS UK and Syncope Trust And Reflex Anoxic Seizures (STARS). Resources and PPI payment were secured through the West Midlands Research Design Service PPI fund and the British Heart Foundation grant was written specifically to include the iterative processes of co-creating the intervention and feasibility protocol. Recognition included acknowledgment on the PULSE ( www.pulse-project.coventry.ac.uk ) and hEDS Together websites throughout the project where consent was given and invitation to co-author publications. Consistency was enhanced by using the three co’s framework of co-creation [], and leadership of the PPI was by a researcher with PoTS and experience of being a PPI member for other research (GP), working alongside a multidisciplinary team. Funding Information: This study is funded by a British Heart Foundation (BHF) Project Grant: PG/ 19/22/34203. The views expressed are those of the authors and not necessarily those of the BHF. The PPI co-define activity for the grant application was funded by the West Midlands Research Design Service PPI Grant. JB is supported by National Institute for Health Research (NIHR) Research Capability Funding via UHCW NHS Trust.

Keywords

  • Postural tachycardia syndrome
  • Exercise
  • Physical Activity
  • Cardiac Rehabilitation
  • Dysautonomia
  • Feasibility randomised controlled trial
  • intervention development
  • co-creation
  • co-production
  • patient and public involvement

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