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PARADIGM
Sponsor study identifier
observational
217
1 country
1
Study Start
February 6, 2022
Actual (reported)Primary Completion
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 6, 2022
Actual (reported)April 4, 2022
Actual (reported)June 29, 2022
Actual (reported)August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The incidence and prevalence of delirium in older people with Parkinson's, measured by the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorders 5th edition).
DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th edition) will be used to confirm the diagnosis of delirium.
Time frame: measured when the participant has previously encountered healthcare professionals during 2015-2019.
The duration of delirium will be measured in days.
Once delirium is confirmed by the DSM-V criteria, then the number of days that participants are affected by delirium will be inferred from medical notes.
Time frame: measured when the participant has previously encountered healthcare professionals during 2015-2019.
People with Parkinson's who have experienced persistent delirium (delirium lasting for ≥14 days) and will also be invited to interview.
People with Parkinson's who have experienced non-persistent delirium (delirium lasting \<14 days).
People with Parkinson's who have never experienced delirium
Carers of people with Parkinson's who have consented to being interviewed.
No interventions.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
1. People aged 65 years or older in 2015, with a diagnosis of idiopathic Parkinson's, who attend the outpatient clinic at Airedale Hospital and have had a hospital admission of at least 24 hours during 2015-2019. 2. A carer (aged 18 years and older) for a person with Parkinson's, who has experienced persistent delirium.
Airedale Hospital
Keighley, West Yorkshire, BD20 6TD, United Kingdom
AMERICAN PSYCHIATRIC ASSOCIATION 2013. Delirium. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC.
Billings J, Mijanovich T. Improving the management of care for high-cost Medicaid patients. Health Aff (Millwood). 2007 Nov-Dec;26(6):1643-54. doi: 10.1377/hlthaff.26.6.1643.
BRAUN, V. & CLARKE, V. 2006. Using thematic analysis in psychology. Qualitative research in psychology, 3, 77-101.
William Lee, MB/BS
Airedale Hospital
First Submitted
April 4, 2022
First Posted
June 29, 2022
Study Start
February 6, 2022
Actual (reported)Primary Completion
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Cole MG, Ciampi A, Belzile E, Zhong L. Persistent delirium in older hospital patients: a systematic review of frequency and prognosis. Age Ageing. 2009 Jan;38(1):19-26. doi: 10.1093/ageing/afn253. Epub 2008 Nov 18.
Davis DH, Muniz Terrera G, Keage H, Rahkonen T, Oinas M, Matthews FE, Cunningham C, Polvikoski T, Sulkava R, MacLullich AM, Brayne C. Delirium is a strong risk factor for dementia in the oldest-old: a population-based cohort study. Brain. 2012 Sep;135(Pt 9):2809-16. doi: 10.1093/brain/aws190. Epub 2012 Aug 9.
Kakuma R, du Fort GG, Arsenault L, Perrault A, Platt RW, Monette J, Moride Y, Wolfson C. Delirium in older emergency department patients discharged home: effect on survival. J Am Geriatr Soc. 2003 Apr;51(4):443-50. doi: 10.1046/j.1532-5415.2003.51151.x.
Kouli A, Torsney KM, Kuan WL. Parkinson's Disease: Etiology, Neuropathology, and Pathogenesis. In: Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Chapter 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK536722/
Lawson RA, McDonald C, Burn DJ. Defining delirium in idiopathic Parkinson's disease: A systematic review. Parkinsonism Relat Disord. 2019 Jul;64:29-39. doi: 10.1016/j.parkreldis.2018.09.025. Epub 2018 Sep 26.
Lubomski M, Rushworth RL, Tisch S. Hospitalisation and comorbidities in Parkinson's disease: a large Australian retrospective study. J Neurol Neurosurg Psychiatry. 2015 Mar;86(3):324-30. doi: 10.1136/jnnp-2014-307822. Epub 2014 May 29.
MEHRA, A., SURENDRAN, I., SURI, V. & GROVER, S. 2014. Missed diagnosis-persistent delirium. Journal of Geriatric Mental Health, 1, 118.
Read J, Cable S, Lofqvist C, Iwarsson S, Bartl G, Schrag A. Experiences of health services and unmet care needs of people with late-stage Parkinson's in England: A qualitative study. PLoS One. 2019 Dec 30;14(12):e0226916. doi: 10.1371/journal.pone.0226916. eCollection 2019.
Siddiqi N, House AO, Holmes JD. Occurrence and outcome of delirium in medical in-patients: a systematic literature review. Age Ageing. 2006 Jul;35(4):350-64. doi: 10.1093/ageing/afl005. Epub 2006 Apr 28.
ROSNER, B. 2015. Fundamentals of biostatistics, Cengage learning.
TAYLOR, S. J. & BOGDAN, R. 1984. Introduction to qualitative research methods: The search for meanings, Wiley-Interscience.
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
Frank M, Sivagnanaratnam A, Bernstein J. Nutritional assessment in elderly care: a MUST! BMJ Qual Improv Rep. 2015 Jan 22;4(1):u204810.w2031. doi: 10.1136/bmjquality.u204810.w2031. eCollection 2015.
Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.
Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
Kuhn E, Du X, McGrath K, Coveney S, O'Regan N, Richardson S, Teodorczuk A, Allan L, Wilson D, Inouye SK, MacLullich AM, Meagher D, Brayne C, Timmons S, Davis D. Validation of a consensus method for identifying delirium from hospital records. PLoS One. 2014 Nov 4;9(11):e111823. doi: 10.1371/journal.pone.0111823. eCollection 2014.
Study Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 1, 2023
Record last verified: 2023-05
To occur after the PARADIGM has published its study findings.
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Source: ClinicalTrials.gov.
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