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Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial
Introduction
The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost-effective and scalable across contexts are key questions beyond that of whether ‘it works’. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care.
Methods and analysis
A mixed-methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semistructured interviews with a purposively sampled subpopulation of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions.
Ethics and dissemination
The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27 July 2021. The qualitative data will be collected as part of a substudy, ‘PRIME-Qual’, which was granted NHS REC approval (21/LO/0388) on 14 July 2021. The mixed-methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings.
Trial registration number
NCT05127057.
Abstract WP310: Midlife Vascular Risk Factors, Dementia, and Parkinson's Disease-Dementia in the Atherosclerosis Risk in Communities (ARIC) Cohort
Stroke, Volume 56, Issue Suppl_1, Page AWP310-AWP310, February 1, 2025. Background:Vascular risk factors, particularly in midlife, are associated with an increased risk of dementia, and smoking has been inversely associated with Parkinson’s disease (PD) risk, but the role of these factors in PD-dementia (PDD) is less clear. This study explores whether midlife vascular risk factors are associated with risk of PDD in the community-based ARIC cohort.Methods:ARIC participants were evaluated for vascular risk factors (hypertension, diabetes, hypercholesterolemia, smoking, and obesity) in 1987-1989 (ages 44-64) and followed through 2016. PD cases were identified using participant medications, self-reported physician diagnosis, hospitalization and death surveillance, and PD diagnostic data provided by participants and physicians. Dementia was defined by in-person and phone-based cognitive assessment, informant interviews, and hospitalization codes. PDD was defined as having both a PD and dementia diagnosis, with the PD diagnosis occurring first. We excluded participants with missing covariates, on neuroleptic medications, or with PD or dementia at baseline. Adjusted Cox proportional hazards models examined the associations between midlife vascular risk factors (combined in one model) and incident PDD, PD/no dementia, and dementia/no PD, vs no PD/no dementia. We explored effect modification by race.Results:Of 13,875 participants (25% Black, 54% female), 179 developed PD at a mean age of 73.4 yo, 94 devleoped PDD at a mean age of 79.2 yo, and 1,791 developed dementia/no PD at a mean age of 79.7 yo. Midlife current smoking (HR 0.41, 95% CI 0.18-0.95, Figure) was signficantly associated with a lower risk of PDD; other vascular risk factors had nonsignficiant associations. Older age, APOEe4, male sex, and low education were significantly assoiated with an increased risk of PDD. Smoking, diabetes, hypertension, obesity, Black race, age, low education, male sex, and APOEe4 were associated with an increased risk of dementia/no PD. There was effect modification by race for smoking and obesity, which were significant risk factors for dementia/no PD in White but not Black participants (Table).Conclusions:Smoking in midlife was significantly associated with a lower rate of PDD vs no PD/no dementia. Other vascular risk factors were not associated with PDD, but demographic associations were similar to dementia. Future studies should evaluate these vascular risk factors over the life course and the mechanisms underlying these associations.
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Digital health technologies and self-efficacy in Parkinsons: a scoping review
Objective
Prior research has identified that people with Parkinson’s reporting lower levels of self-efficacy exhibit worsening motor and non-motor symptomology, reduced quality of life, and self-management. Our key objective was to conduct a scoping review examining the impact of digital health technologies on self-efficacy in people with Parkinson’s.
Design
A scoping review using Arksey and O’Malley’s (2005) framework was undertaken.
Data sources
MEDLINE, Embase, PsychINFO, CINAHL, Web of Science, IEEE Xplore, and Google Scholar principally for grey literature were searched from 1 January 2008 to the 24th of July 2024.
Eligibility criteria for selecting studies
Primary studies which incorporated digital health technologies, measured self-efficacy and had a sample population of people with Parkinson’s were searched.
Data extraction and synthesis
Following identification of potentially eligible records, two independent reviewers undertook title and abstract screening, followed by full-text screening. Data was extracted using our earlier published data extraction sheet which incorporated the Practical Reviews in Self-Management Support (PRISMS) taxonomy, and the template for intervention description and replication (TIDieR) checklist. Data was extracted from a Microsoft Excel spreadsheet and synthesised by describing themes, demographic data and numerical data.
Results
From 33 165 unique records following screening and independent review by two reviewers, 11 eligible records were found. Of these five elevated self-efficacy to a statistically significant level, five did not and one lowered self-efficacy. Of the studies which raised self-efficacy to a statistically significant level, all adopted a multimodal approach with a variety of devices. Thematically, these devices were focused on physical activity, falls/falls prevention, or both. The level of heterogeneity precluded comparisons between studies.
Conclusions
This scoping review identified significant knowledge and evidence gaps in the literature, and the limited number of eligible studies make these findings not generalisable. Future self-management research might benefit from also considering self-efficacy.
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