An interventional study of NMS Assist in Parkinson Disease, sponsored by Newcastle University. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Newcastle University · Not applicable, Interventional, and Supportive care
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.
Such 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.
A smaller group of participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development.
It 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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Newcastle University is the lead sponsor of 60 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Individuals will be eligible if they meet the following inclusion criteria:
All:
For clinically diagnosed people with Parkinson's (PwP) (ICD-10-CM G20):
For CPs:
- Be caring for a clinically diagnosed PwP (ICD-10-CM G20) who is participating in the study
Exclusion Criteria: Participants will be ineligible for the study if they meet any of the following exclusion criteria:
All:
PwP:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: NMS Assist
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.
Feasibility of the intervention
The primary outcome will be assessed using a composite of variables: recruitment, retention, system uptime, adherence/engagement, technical issues, and a review of the health and well-being outcomes (secondary outcomes). Adherence/engagement 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.
Time frame: Assessed throughout the 6-month study duration
Presence of non-motor symptoms
Measured using the Non-Motor Symptoms Questionnaire (NMSQ), patients tick 'yes' or 'no' for each symptom listed
Time frame: Measured monthly for 6 months
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
Time frame: Assessed monthly for 6 months
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/or severity
Time frame: Measured at baseline, 3, and 6 months
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
Time frame: Measured at baseline, 3, and 6 months
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
Time frame: Measured monthly for 6 months
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
Time frame: Measured monthly for 6 months
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
Time frame: Measured at baseline, 3, and 6 months
Adverse events
Adverse event reporting
Time frame: Throughout the 6-month study period
Healthcare contacts
Number of PwP-initiated contacts with healthcare team (through the 'request healthcare contact' feature) recorded by the system
Time frame: Throughout the 6-month study period
Quantitative usability
Using the mHealth app usability questionnaire (MAUQ) with higher scores indicating better usability
Time frame: 3 and 6 months
Acceptability
Acceptability and usability feedback from semi-structured interviews
Time frame: 3 and 6 months
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.
Time frame: Throughout 6 months
Plan to share: Undecided — Data belongs to the study sponsor (Newcastle University) and deidentified data will be made available in line with the data sharing policy developed with Parkinson's UK and PPI representatives.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Sep 2026, 13 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 13 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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