NCT05437458: PARADIGM

Parkinson's Disease: Risk Assessment of Persistent Delirium and Its Management

Status unknown Last updated 1 June 2023

What this trial tests

trial testing Delirium (exposure) in Parkinson Disease in 217 participants. Status unknown.

Timeline

6 February 2022

Primary endpoint
30 August 2025

30 September 2025

Quick facts

Lead sponsor	Newcastle University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	217
Start date	6 February 2022
Primary completion	30 August 2025
Estimated completion	30 September 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• Delirium (exposure)

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Delirium in Old Age — all drugs for Delirium in Old Age →

Sponsor

Newcastle University

Who can join

18 and older, any sex, with Parkinson Disease or Delirium in Old Age. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: delirium describes the change in people's behaviour and thinking when they are unwell. People with delirium may appear confused, have difficulty with organisation and can be different to their usual personality. Older people with Parkinson's are particularly susceptible to persistent delirium, which can last over 14 days. They are more likely to need increased community support and they have a greater risk of death and dementia.

However, there is limited research for people with Parkinson's on how to effectively manage persistent delirium and how to identify those at risk of persistent delirium. Community support may not sufficiently support the care needs of people with Parkinson's, and this is expected to be more detrimental for people also affected by persistent delirium

Study Design: retrospective case note review with qualitative interviews.

Study participants: older people (≥65 years old) with Parkinson's disease, previously affected by either persistent delirium or another form of delirium (e.g. hyperactive, hypoactive, mixed). 207 participants with Parkinson's for quantitative data collection. The qualitative study will include up to 10 participants with Parkinson's from the quantitative part of this study. An additional maximum of 10 more carers for people with Parkinson's may also be interviewed.

Research Aims:

1. To develop and estimate the assessment tool's sensitivity and specificity to predict persistent delirium in older people with Parkinson's in the outpatient setting. Persistent delirium in this study will be initially defined as a delirium lasting ≥14 days. An associated secondary objective will be to develop a scoring system that allocates an increasing number of points to risk factors that have a stronger association for predicting delirium.
2. To evaluate the management strategies used for persistent delirium.
3. To determine what are the community care needs for people recovering from persistent delirium.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.