Clinical Investigation of NMS Assist

NCT05414071 | Withdrawn

• 1 other identifier: AM1000398
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Parkinson Disease; Self-Management; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Patient (and care partner) activation

  Patient Activation Measure (and caregiver version) will be used to evaluate their confidence, knowledge, and skills at non-motor symptom self-management

  Assessed monthly for 12 months

Secondary Outcomes (16)

• Presence of non-motor symptoms

  Measured at patients' discretion throughout intervention (12 months)

• Frequency and severity of non-motor symptoms

  Measured at baseline, 6, and 12 months

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

  Measured at patients' discretion throughout intervention (12 months)

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

  Measured at baseline, 6, and 12 months

• Carer well-being and quality of life

  Measured at care partners' discretion throughout intervention (12 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:

• Willing and able to provide informed consent and comply with intervention requirements
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Plymouth: lead

Related Publications (1)

• 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.

  PMID: 36155396 DERIVED

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: Associate Professor of eHealth

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 10, 2022
• Study Start: December 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06