Patient Engagement Investigation of NMS Assist

NCT ID: NCT07038486

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-06
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

NMS Assist

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.

Group Type: EXPERIMENTAL

NMS Assist

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Newcastle University

OTHER

Sponsor Role: lead

Responsible Party

Edward Meinert

Professor of Digital Health and Clinical Artificial Intelligence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Newcastle University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Edward Meinert, PhD

Role: primary

depth.ai@newcastle.ac.uk

01912083811

Cen

Role: backup

Other Identifiers

H-2101

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202425 16 Caroll

Identifier Type: -

Identifier Source: org_study_id