How have people with Parkinson's and their families helped shape TOP HAT?

A Parkinson’s UK focus group, comprised of people with Parkinson’s and those with experience of caring for a family member with Parkinson’s hallucinations, was involved early in the study planning process. This group made important contributions to the study design, including the timing and location of assessments, choice of outcome measures, and the inclusion of blood sampling to inform dosage strategies for clinical use. The group supported a flexible dosing strategy, to reduce the risk of side-effects, and suggested use of a tablet, instead of a (larger) capsule, as people with Parkinson's can have swallowing difficulties.

The focus group has also developed our recruitment strategy, and will increase national awareness of the study through this links with local and regional Parkinson's Committees. It will be involved at every stage, including ethical approval, reviewing patient and caregiver information sheets, trial materials, recruitment, trial management and representation on trial steering committees. The focus group will also work closely with the study team to formalize and deliver a dissemination plan.

Thank you for all your contributions and continued support to our project. A special thanks to co-applicant Mike Wares for his advice and guidance on developing our recruitment strategy and his commitment to our trial.

Specific examples of your contributions
  1. You liked the acronym ‘TOP HAT’ but did not like the logo as it was black! We developed an alternative logo  - Thank you!
  2. You felt very strongly that we should use the term Parkinson's and describe it as a ‘condition’ rather than a ‘disease’ and we do so in all of the trial materials, including training.
  3. You approved our drug of choice (ondansetron) as a treatment for visual hallucinations and suggested that the drug should be administered as a tablet, as capsules are larger and more difficult to swallow.
  4. You made excellent suggestions about how we might maximise recruitment, with the help of Parkinson's UK
  5. You emphasised the need to be inclusive and this is why we extended the age range to include any adult (aged over 18 years) with Parkinson’s.
  6. You gave input into the type and timing of outcome assessments.
  7. You encouraged flexibility in our approach to follow-up assessments, as people with hallucinations can be frail and/or have poor mobility. We have ensured that there is a large enough travel budget to cover home visits by the local team if needed.
  8. You pointed out that lengthy telephone conversations would be fatiguing, so we have limited the number of questions that are asked over the telephone. 
  9. You gave input into the Plain English summary for the grant application.
  10. You gave feedback and suggestions about the number and type of information sheets that we should provide to potential recruitment sites, and to potential participants. This includes a one page flowchart which allows people to see at a glance what taking part will involve.
  11. You provided feedback about the content and layout of this website.