A digital watch strapped to the wrist of 273 people with Parkinson’s is tracking their daily activity and sleep to see whether a self-management programme actually changes how they move and rest. Standard clinical questionnaires used in the PD-Care trial—such as the PDQ-39 quality-of-life survey—capture what people *report* about their condition, but they miss objective, moment-by-moment data on real-world behaviour. This substudy fills that gap by using a wearable activity monitor to measure physical activity levels and sleep patterns continuously for seven days at baseline, six months, and twelve months. Pilot data already showed strong correlations (r=0.40 to 0.98) between the watch’s digital outputs and standard clinical measures of daily living. If the watch data reveal that the intervention boosts daily movement or improves sleep, clinicians and policymakers will have concrete evidence that self-management tools can alter the lived experience of Parkinson’s—not just questionnaire scores. The findings could reshape how future trials assess non-drug interventions, replacing or supplementing subjective reports with objective digital biomarkers. Charities, academics, and the NHS will receive the results through journals, newsletters, and targeted media.
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Aims. To detect changes in activity levels of patients with Parkinson s in the PD-Care trial using a wearable activity monitor (digital watch) for seven days. Background. In the PD-Care programme, we have developed a self-management intervention for people with Parkinson s (PwP), which is currently being tested in a randomised controlled trial (RCT). The primary outcome of the trial is health-related quality of life, measured with the PDQ-39, at 12 months, and secondary outcome measures include other questionnaires and scales to assess the effectiveness and cost-effectiveness of the intervention. Wearable devices can detect information not gathered with these traditional outcome measures, including impact on activity levels in daily life, as well as possible factors mediating the potential impact of the self-management intervention. Pilot data. During the Feasibility study, we collected data from two wearable devices to allow for the selection of the most acceptable device for digital measurement of physical activity. These showed significant correlations between key digital outputs of the devices with the PDQ-39 and the clinical measures of activities of daily living (between r=0.40 and 0.98). Data collected in the currently ongoing RCT include additional information on mechanism of a potential effect as well as other factors relevant to functioning and well-being, such symptom diaries, priorities, and sleep. Work plan. Out of the 346 participants recruited for the PD-Care trial, 273 agreed to participate in the wearable device substudy (which was limited by sensor availability) and completed data collection at baseline. Data collection at 6 and 12 months is ongoing and will be completed in July 2024. We will expand our analysis to include the key variables from the wearable activity monitor to assess the effectiveness of the PD-Care intervention on daily activity levels and sleep. We will compare change in digital activity outcomes from baseline to follow-up and compare this change with that on clinical outcome measures. We will also examine the association between level of activity change on the wearable activity monitor and possible mediating factors, e.g. self-reported diary data and priorities chosen by participants at baseline. Timelines for delivery. The research will run for 12 months (May 2025- April 2026), starting during the last 5 months of the current award. Anticipated Impact and Dissemination. The results will provide additional information on the intervention's impact on digitally measured activity levels and sleep, as well as on the effectiveness and mechanism of a potential impact of this intervention to help PwP self-manage their condition. We will disseminate our findings to key stakeholders such as charities, academics, and policymakers via peer-reviewed journal publications, newsletters, and targeted media activity.
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