What is CHIEF-PD, and how is it going?

Posted on by gezina.lambert

Here’s a refresher – or a helpful introduction for anyone new to our work – on what CHIEF-PD is all about, and our progress so far. Slides created by our Research Support Assistant, Kritika Jain.

What is CHIEF-PD?

CHIEF-PD stands for... Cholinesterase Inhibitors to Prevent Falls in Parkinson's

CHIEF-PD is a drug trial testing use of Rivastigmine in people with Parkinson's to prevent falls

CHIEF-PD study is funded by NIHR Health Technology Assessment Programme. The National Institute for Health Research fund health and care research and translate discoveries into practical products, treatments, devices, and procedures, involving patients and the public in their work.

CHIEF-PD is a double-blind randomised controlled trial. Trial participants were randomly divided into 2 groups. One group gets a medication patch, the other group gets a patch with no medication, which we call a placebo. Participants and researchers are both unaware of which group they are in, and if they are getting the medication or not. This is why the trial is "double blind".

We have recruited 600 participants from 39 NHS sites from all over the UK.

Who are the participants? Diagnosed with idiopathic Parkinson’s disease. Modified Hoehn and Yahr stage 1-4 at baseline visit. Minimum of 1 fall in past 12 months. Able to walk at least 10 metres without aid or assistance. Aged 18 years or above.

What are the steps? Baseline visit: baseline testing, patient randomly group to receive either Rivastigmine or placebo patches throughout the trial (remember- this is kept secret!) 2. Month 0: Starting on low dose Rivastigmine or placebo patches for 30 days. Month 1: Uptitrating to medium dose Rivastigmine or placebo patches. Month 1-6: Continuation on medium dose Rivastigmine or placebo patches for 5 months. Month 6: Uptitration to high dose Rivastigmine or placebo patches. Month 6-12 continuation on high dose patches for 6 months. Month 12 - stopping the patches, and follow-up testing.

What are we measuring? Primary outcomes: We are measuring if people using Rivastigmine compared to those using placebo experience fewer falls during the 12 months follow up period.

Secondary outcomes: We are also measuring changes in cognition and memory, overall health and wellbeing, and economic burden on the NHS.

How are we measuring? Participants will record the dose of the medicine patch with coloured stickers and numbers of falls on a falls sheet for each calendar month. Participants will also complete 3 monthly healthcare questionnaires and physical and cognitive testing at months 0 and 12 to measure secondary outcomes.

How are we doing so far? CHIEF-PD trial has successfully completed the follow up for all the participants. It has become the largest novel drug trial for Parkinson’s Disease in the UK. We won lead network study of the year from Clinical Research Network West of England.

What is next for CHIEF-PD? Once the database is locked, we can reveal who received treatment vs placebo. Then, the CHIEF team will begin analysing the results. And we’re hoping to present the preliminary results soon- so watch this space!

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