Clinical Investigation of NMS Assist

NCT ID: NCT05414071

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-03-01

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, 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.

Conditions

Parkinson

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

• 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

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

Sponsors

University of Plymouth

OTHER

Sponsor Role: lead

Responsible Party

Edward Meinert, PhD

Associate Professor of eHealth

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Meinert E, Milne-Ives M, Chaudhuri KR, Harding T, Whipps J, Whipps S, Carroll C. The Impact of a Digital Artificial Intelligence System on the Monitoring and Self-management of Nonmotor Symptoms in People With Parkinson Disease: Proposal for a Phase 1 Implementation Study. JMIR Res Protoc. 2022 Sep 26;11(9):e40317. doi: 10.2196/40317.

Reference Type: DERIVED

PMID: 36155396 (View on PubMed)

Other Identifiers

AM1000398

Identifier Type: -

Identifier Source: org_study_id