Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT05437458
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria for People with Parkinson's:
1. Participants must be aged at least 65 years old in 2015.
2. Participants must have a diagnosis of idiopathic Parkinson's disease using Queen's Square Brain Bank criteria (32) diagnosed by a movement disorders expert.
3. Admitted patients must have stayed in hospital \>24 hours for at least one hospital admission.
4. Participants must have had previous admissions/attendance to the hospital between 2015-2019.
5. An appropriate consultee must be available and willing to be involved in this study for potential participants without the mental capacity to consent to the extraction of information from their medical records.
6. For the qualitative study, participants must have the mental capacity to consent and must have been affected by persistent delirium. The participant must be able to understand, write and speak English.
Inclusion Criteria for Carers in the Qualitative Study
1. Participants must be aged 18 or over.
2. Participants must have the mental capacity to consent.
3. Participants must have been a primary carer for someone living with Parkinson's, who has had a previous experience of persistent delirium, during 2015-2020.
4. Participants must be able to understand, write and speak English.
Exclusion Criteria:
Exclusion Criteria for People with Parkinson's
1. Aged less than 65 years old in 2015.
2. Diagnosed with drug-induced parkinsonism, vascular parkinsonism, atypical Parkinsonian disorder (e.g. progressive supranuclear palsy, multiple systems atrophy, corticobasal syndrome) or dementia (e.g. dementia with Lewy bodies, vascular dementia, Alzheimer's disease).
3. Potential participants will be excluded from the interview if they cannot communicate verbally or cannot read/write in English.
4. The potential participant's medical records are incomplete and no alternate strategies are appropriate to account for the missing data, without introducing significant study bias or inaccuracy in statistical findings. Criteria for when the medical records will be excluded in the analysis will be:
1\. There is uncertainty regarding the identity of the medical records. 2. Documentation for the admission of interest is missing to the extent that researchers are unable to extract the relevant data required for the aims of this study.
5\) For the qualitative study, potential participants will be excluded if they do not have the mental capacity to consent.
6\) Potential participants without a consultee and also do not have the mental capacity to consent to this study.
7\) Potential deceased participants will be excluded if there is previous documentation that the person would not have wanted to participate in research studies.
Exclusion Criteria for Carers in the Qualitative Study
1. The potential participant is aged less than 18 years old.
2. The potential participant does not have the mental capacity to consent to this study.
3. The potential participant is not the primary carer for someone with Parkinson's and has been affected by persistent delirium, during 2015-2020.
4. The potential participant does not understand, write and/or speak English.
5. The potential participant has a severe speech impairment to the extent that the audio recording of the interview is unintelligible.
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05437458
Study Brief:
Protocol Section:
NCT05437458