Patient Engagement Investigation of NMS Assist

Newcastle University

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: NMS Assist

Study type: Interventional

Funder types: Other

Identifiers

NCT07038486

H-2101 (Other Grant/Funding Number)

202425 16 Caroll

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NMS Assist

Experimental group

Description:

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.

Treatment:

Device: NMS Assist