Abstract
INTRODUCTION:
Postural orthostatic tachycardia syndrome (POTS) is a long-term condition with an often disabling impact on quality of life. People with long-term conditions have to learn how to manage their condition. The evidence into interventions supporting people with POTS to learn self-management strategies is limited. The supportive self-management in POTS study (SSPOTS) aims to co-produce and feasibility test a POTS intervention. The research aims to evaluate the feasibility of a co-produced POTS supportive self-management intervention developed from the experiences of POTS.
METHODS
SSPOTS is an exploratory sequential three phased intervention development and feasibility testing design. A SSPOTS public and patient advisory board will advise on key study questions. Phase one will be a qualitative study of the experiences of POTS from the perspectives of people with POTS and health care practitioners. Data on the components of supportive self-management will then be extracted and mapped to the PRISMS taxonomy of supportive self-management components. In phase two, the taxonomized results from phase one will be taken to first an intervention co-designing workshop, and then to a second co-refining workshop. In the first co-designing workshop key people from a charity network and health care professionals will prioritise intervention components through nominal group technique. An intervention framework will be developed from these results, and a proposed intervention will be circulated to participants for co-refining. The second workshop will explore areas for co-refining. Phase three will be the feasibility testing of SSPOTS.
DISCUSSION
The primary outcome for the feasibility testing will be the number of eligible potential participants who convert into participants. Secondary outcome measures will be 1) adherence to sessions, 2) intervention fidelity, 3) outcome measure calculations of mean, medium and standard deviation to inform a sample size calculation for a potential future trial and 4) a focused process evaluation of intervention acceptability. Purposive sampling from three NHS identification sites with POTS services will aim to recruit a maximum of 30 participants. The feasibility study will inform the practicality of a definitive SSPOTS randomised control trial.
ETHICAL APPROVALS:
Ethical approval was sought initially for phase one, Chelsea Research Ethics Committee (HRA: 281841 25/6/21). Subsequent phases were granted ethical approval through substantial amendments to the original protocol. The initial protocol was for the phase one qualitative study, the first substantial amendment (09/09/2022) was for the co-production workshops and the second substantial amendment (23/08/2023) for the programme feasibility testing