[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595902":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":56,"studyPopulation":56,"armGroups":63,"interventions":70,"overallOfficials":56,"centralContacts":56,"locations":75,"responsibleParty":97,"collaborators":56,"id":101,"slug":56,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":56,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":56,"enrollmentInfo":109,"targetDuration":56,"studyType":112,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":77,"whyStopped":56,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Newcastle University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of the intervention","The primary outcome will be assessed using a composite of variables: recruitment, retention, system uptime, adherence\u002Fengagement, technical issues, and a review of the health and well-being outcomes (secondary outcomes).\n\nAdherence\u002Fengagement will be measured using system use data (trend of use over time). This will be supplemented with semi-structured interviews and a user engagement questionnaire to gain a better understanding of users' experience engaging with the intervention and the recommended behaviours. Technical issues will be identified through system use data (including logs of complaints made by participants during the intervention delivery period) as well as asking participants about any technical issues encountered during the semistructured interviews. Product complaints will be collected through feedback recorded via the platform, collected at study assessment points or manually provided via email throughout the study duration.","Assessed throughout the 6-month study duration",[14,18,22,26,29,32,35,38,42,45,49,52],{"measure":15,"description":16,"timeFrame":17},"Presence of non-motor symptoms","Measured using the Non-Motor Symptoms Questionnaire (NMSQ), patients tick 'yes' or 'no' for each symptom listed","Measured monthly for 6 months",{"measure":19,"description":20,"timeFrame":21},"Patient (and care partner) activation","Patient Activation Measure (and caregiver version) will be used to evaluate their confidence, knowledge, and skills at non-motor symptom self-management","Assessed monthly for 6 months",{"measure":23,"description":24,"timeFrame":25},"Frequency and severity of non-motor symptoms","Measured using the Movement Disorder Society Non-Motor Symptoms Scale (MDS-NMS), where higher scores indicate greater frequency and\u002For severity","Measured at baseline, 3, and 6 months",{"measure":27,"description":28,"timeFrame":25},"Long-form self-assessment of functioning and well-being related to Parkinson's disease","Measured using the long-form Parkinson's Disease Questionnaire PDQ-39, patients indicate the frequency with which they experience certain issues",{"measure":30,"description":31,"timeFrame":17},"Short-form self-assessment of functioning and well-being related to Parkinson's disease","Measured using the short-form Parkinson's Disease Questionnaire (PDQ-8), patients indicate the frequency with which they experience certain issues",{"measure":33,"description":34,"timeFrame":17},"Carer well-being and quality of life","Measured using the Parkinson Disease Questionnaire for care partners; care partners indicate the frequency with which they experience certain issues",{"measure":36,"description":37,"timeFrame":25},"Health status","Measured using the EQ-5D-5L; higher scores on the EQ-5D-5L descriptive system indicate worse health problems in the specific dimension whereas a high score in the EQ VAS indicates better health on the day of the questionnaire",{"measure":39,"description":40,"timeFrame":41},"Adverse events","Adverse event reporting","Throughout the 6-month study period",{"measure":43,"description":44,"timeFrame":41},"Healthcare contacts","Number of PwP-initiated contacts with healthcare team (through the 'request healthcare contact' feature) recorded by the system",{"measure":46,"description":47,"timeFrame":48},"Quantitative usability","Using the mHealth app usability questionnaire (MAUQ) with higher scores indicating better usability","3 and 6 months",{"measure":50,"description":51,"timeFrame":48},"Acceptability","Acceptability and usability feedback from semi-structured interviews",{"measure":53,"description":54,"timeFrame":55},"Costs will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI)","Cost analysis will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI) for Parkinson's disease. The scale will be administered at 3 and 6 months.","Throughout 6 months",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":62,"maskingDescription":56,"whoMasked":56},"NONE",[64],{"label":65,"type":66,"description":67,"interventionNames":68},"NMS Assist","EXPERIMENTAL","NMS Assist provides a system of linking PwP, CPs, and healthcare providers (HCPs) to monitor and empower self-management of non-motor symptoms through the use of a mobile app and web portal.",[69],"Device: NMS Assist",[71],{"type":72,"name":65,"description":73,"armGroupLabels":74,"otherNames":56},"DEVICE","The system enables people with Parkinson's and their care partners to complete questionnaires about symptoms and burden and share that information with their care team. They can also access self-help resources and materials about managing non-motor symptoms. Healthcare providers have a dashboard that flags any worsening symptoms or discrepancies between PwP and CP reports, enabling their to prioritise care and quickly see the status of their patients. The system also enables PwP or CPs to request healthcare contact.",[65],[76],{"facility":5,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"RECRUITING","Newcastle upon Tyne","Tyne and Wear","NE4 8EA","United Kingdom","UK",{"type":84,"coordinates":85},"Point",[86,87],-1.61396,54.97328,{"lat":87,"lon":86},[90,95],{"name":91,"role":92,"phone":93,"phoneExt":56,"email":94},"Edward Meinert, PhD","CONTACT","01912083811","depth.ai@newcastle.ac.uk",{"name":96,"role":92,"phone":56,"phoneExt":56,"email":56},"Cen",{"type":98,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"PRINCIPAL_INVESTIGATOR","Edward Meinert","Professor of Digital Health and Clinical Artificial Intelligence","100595902",false,"NCT07038486","Patient Engagement Investigation of NMS Assist","The Impact of a Digital System on the Monitoring and Self-management of Non-motor Symptoms in People With Parkinson's","Inclusion Criteria: Individuals will be eligible if they meet the following inclusion criteria:\n\nAll:\n\n* Age 18 years or over\n* Have compatible smartphone\u002Fdata access (access to a digital device is a necessary prerequisite of system use, and the formative usability study had success in recruiting participants with varying levels of experience with smartphones)\n* Be fluent in English\n* Able and willing to provide informed consent\n* Able and willing to comply with intervention requirements\n\nFor clinically diagnosed people with Parkinson's (PwP) (ICD-10-CM G20):\n\n* Not resident in a care home or nursing home\n* Ambulant\n* Interested in monitoring and managing their NMS\n\nFor CPs:\n\n\\- Be caring for a clinically diagnosed PwP (ICD-10-CM G20) who is participating in the study\n\nExclusion Criteria: Participants will be ineligible for the study if they meet any of the following exclusion criteria:\n\nAll:\n\n* Previous involvement in the development or testing of the digital system\n* In a dependent\u002Funequal relationship with the research or care teams or any PPI representatives\n\nPwP:\n\n* Secondary cause of Parkinsonism\n* Significant cognitive impairment or a diagnosis of Parkinson's disease dementia\n* Significant comorbidity, which, in the opinion of the chief investigator, would preclude safe participation in the study or protocol compliance\n* A life expectancy of \\\u003C6 months\n* Living in residential care facilities","ALL","18 Years",{"count":110,"type":111},30,"ESTIMATED","INTERVENTIONAL",[58],"Parkinson's can cause a wide range of non-motor symptoms (NMS), including pain and problems with mental health, memory and sleep. These affect the quality of life of people with Parkinson's (PwP) and their care partners (CP). If these issues are not recognised and managed quickly, they can result in escalating problems. Many PwP are unsure of the extent and variety of the NMS and how simple adjustments at home could improve them. We have developed a digital system to help PwP monitor their non-motor symptoms and develop skills to self-manage them.\n\nSuch a tool needs to be simple to use, safe and effective. We will ask 30 PwP and CPs to use the digital tool for 6 months, and we will monitor how they use the tool. PwP and CPs will be asked if they feel more knowledgeable and confident to manage their own symptoms whilst being better able to discuss a problem with their healthcare professional.\n\nA smaller group of participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development.\n\nIt is thought that the use of this system will result in improved quality of life and increased knowledge and confidence for managing symptoms while safely reducing the time spent by healthcare professionals on manageable non-motor symptoms.",[116],"Parkinson Disease",[118,119,120,121,122],"Parkinson disease","Self-management","mhealth","mobile apps","telemedicine","2026-01-05",{"date":125,"type":126},"2026-01-08","ACTUAL",{"date":128,"type":126},"2025-08-06",{"date":130,"type":111},"2026-12-31",{"name":5,"class":6},1]