Patient Engagement Investigation of NMS Assist

NCT07038486 | Recruiting

• 2 other identifiers: 202425 16 CarollH-2101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Parkinson disease; Self-management; mhealth; mobile apps; telemedicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed throughout the 6-month study duration

Secondary Outcomes (12)

• Presence of non-motor symptoms

  Measured monthly for 6 months

• Patient (and care partner) activation

  Assessed monthly for 6 months

• Frequency and severity of non-motor symptoms

  Measured at baseline, 3, and 6 months

• Long-form self-assessment of functioning and well-being related to Parkinson's disease

  Measured at baseline, 3, and 6 months

• Short-form self-assessment of functioning and well-being related to Parkinson's disease

  Measured monthly for 6 months

Study Arms (1)

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.

Device: NMS Assist

Interventions

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. 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.

NMS Assist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Newcastle University: lead

Study Sites (1)

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE4 8EA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Digital Health and Clinical Artificial Intelligence

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 26, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

GB (1)