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Patient Engagement Investigation of NMS Assist

Sponsor: Newcastle University

NCT ID: NCT07038486

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NMS Assist (device)
How long the study runs
Study runs about 16 months (dates as stated)
About the drug or intervention
NMS Assist — 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
30
Started
2025-08-06
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for parkinson disease
  • • NA - 30 participants
  • • Parkinson's can cause a wide range of non-motor symptoms (NMS), including pain and problems with mental health, memory and sleep

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with parkinson disease

Where?

  • • Newcastle upon Tyne - Newcastle University

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Parkinson Disease

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Individuals will be eligible if they meet the following inclusion criteria:
  • ✓Age 18 years or over
  • ✓Be fluent in English
  • ✓Able and willing to provide agreement to take part
  • ✓Able and willing to comply with intervention requirements

Who cannot take part

  • ✗Participants will be ineligible for the study if they meet any of the following exclusion criteria:
  • ✗Previous involvement in the development or testing of the digital system
  • ✗In a dependent/unequal relationship with the research or care teams or any PPI representatives
  • ✗Secondary cause of Parkinsonism
  • ✗Significant cognitive impairment or a diagnosis of Parkinson's disease dementia
See the full criteria
Inclusion Criteria: Individuals will be eligible if they meet the following inclusion criteria: All: * Age 18 years or over * Have compatible smartphone/data 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) * Be fluent in English * Able and willing to provide informed consent * Able and willing to comply with intervention requirements For clinically diagnosed people with Parkinson's (PwP) (ICD-10-CM G20): * Not resident in a care home or nursing home * Ambulant * Interested in monitoring and managing their NMS 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: * Previous involvement in the development or testing of the digital system * In a dependent/unequal relationship with the research or care teams or any PPI representatives PwP: * Secondary cause of Parkinsonism * Significant cognitive impairment or a diagnosis of Parkinson's disease dementia * Significant comorbidity, which, in the opinion of the chief investigator, would preclude safe participation in the study or protocol compliance * A life expectancy of \<6 months * Living in residential care facilities

Where Is This Study? (1 UK site)

Newcastle University

Newcastle upon Tyne NE4 8EA, United Kingdom

Recruiting
Site contact (verified)
Data sourced from ClinicalTrials.gov · Last verified: 2026-01