Clinical Investigation of NMS Assist

University of Plymouth

Status: Not yet enrolling

Conditions: Parkinson

Treatments: Device: NMS Assist

Study type: Interventional

Funder types: Other

Identifiers

NCT05414071

AM1000398

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, NMS Assist, 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 60 PwP, CP and members of their Parkinson's healthcare team to use NMS Assist for 12 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 the participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development. Members of the healthcare team will be asked to assess any improvement in communication with PwP and CPs.

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 health care professionals on manageable non-motor symptoms.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide informed consent and comply with intervention requirements
• 18 years or older
• Be fluent in English
• Not resident in a care or nursing home
• Ambulant
• Have compatible smartphone/data access
• Normally under the care of the Parkinson's service in the participating organisation
• Participant's HCP in the participating organisation consented to participate in the study

Exclusion criteria

• Secondary cause of parkinsonism
• Significant cognitive impairment or a diagnosis of Parkinson's disease dementia
• Living in residential care facilities
• Previous involvement in development or testing of the NMS Assist system
• Significant comorbidity, which in the opinion of the chief investigator would preclude safe participation in the study or protocol compliance (e.g. life expectancy <6 months)
• In a dependent/unequal relationship with anyone involved in the research or care teams

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 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