Objective: This study aims to identify the reasons why people living with Parkinson’s disease (PD) (PwP) became involved with the PD STAT randomised controlled trial and to evaluate their trial experience and that of their carers. The purpose is to understand areas of challenge and where the trial enhanced the participants’ lived experience. The overall objective is to inform recommendations for enhanced study design and encourage future participation in Parkinson’s disease research.

Background: PD STAT is part of the Cure Parkinson’s Trust (CPT) Linked Clinical Trial Initiative (LCTI). The purpose of PD STAT is to determine whether simvastatin has neuroprotective potential in PD. The CPT, a trial co-funder, is keen to facilitate better engagement of PwP with research opportunities and improved trial experiences for PwP. We therefore incorporated a sub-study into PD STAT, exploring the experience of PwP and their carers at the initiation, during and following completion of the trial, including those who had to withdraw as well as those who were found to be ineligible.

Method: Ten participants were recruited from each of 4 groups: PwP participating in PD STAT; carers of trial participants; participants who withdrew from the trial; and PwP who were found to be ineligible. Semi structured interviews were used to gather data from the PwP, soon after their month 1 PD STAT visit. The interviews were all digitally recorded and transcribed verbatim. The transcripts are being analysed for themes using a framework analysis. These study participants were also invited to attend a focus group conducted at the mid point of the trial (month 12) and they were interviewed again at the end of their participation in the study.  A separate focus group was held for carers  (September 2018). PwP who had withdrawn or who were found to be ineligible were interviewed as soon as possible from their leaving the study.

Results: All of the interviews and focus groups have been completed, and analysis is ongoing. The results will describe the participants’ understanding of, as well as motivations and challenges in being involved with PD STAT, in the context of their living with Parkinson’s.

Conclusion: The results of the study will inform improvements in trial design to improve research engagement and trial experience for PwP.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/exploring-the-experience-and-challenges-for-pd-stat-clinical-trial-participants-a-qualitative-study/