Clinical Investigation of NMS Assist

Parkinson Clinical Trial

Official title:

The Impact of a Digital Artificial Intelligence System on the Monitoring and Self-management of Non-motor Symptoms in People With Parkinson's

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05414071
• Other study ID #: AM1000398
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2023
• Source: University of Plymouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Plymouth

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presence of non-motor symptoms	Measured using the Non-Motor Symptoms Questionnaire (NMSQ), patients tick 'yes' or 'no' for each symptom listed	Measured at patients' discretion throughout intervention (12 months)
Secondary	Frequency and severity of non-motor symptoms	Measured using the Movement Disorder Society Non-Motor Symptoms Scale (MDS-NMS), where higher scores indicate greater frequency and/or severity	Measured at baseline, 6, and 12 months
Secondary	Short-form self-assessment of functioning and well-being related to Parkinson's disease	Measured using the short-form Parkinson's Disease Questionnaire (PDQ-8), patients indicate the frequency with which they experience certain issues	Measured at patients' discretion throughout intervention (12 months)
Secondary	Long-form self-assessment of functioning and well-being related to Parkinson's disease	Measured using the long-form Parkinson's Disease Questionnaire PDQ-39, patients indicate the frequency with which they experience certain issues	Measured at baseline, 6, and 12 months
Secondary	Carer well-being and quality of life	Measured using the Parkinson Disease Questionnaire for care partners; care partners indicate the frequency with which they experience certain issues	Measured at care partners' discretion throughout intervention (12 months)
Secondary	Health status	Measured using the EQ-5D-5L; higher scores on the EQ-5D-5L descriptive system indicate worse health problems in the specific dimension whereas a high score in the EQ VAS indicates better health on the day of the questionnaire	Measured at baseline, 6, and 12 months
Secondary	Mental well-being	Measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS); Scores range from 14 to 70 (on the 14 item version) and higher scores indicate greater positive mental wellbeing	Measured at baseline, 6, and 12 months
Secondary	Adverse events	Adverse Event Reporting	Throughout 12 months
Secondary	Clinical safety	Record of any events missed	Throughout 12 months
Secondary	Healthcare contacts	Number of PwP-initiated contacts with healthcare team (through the 'request healthcare contact' feature) and the number of HCP-initiated contacts (due to system flagging PwP based on PwP and CP-reported outcomes), recorded by the system	Throughout 12 months
Secondary	Technical and implementation issues	Technical issues identified from the system use data and by participants and process measures relating to service delivery	Throughout 12 months
Secondary	Quantitative usability	System Usability Scale, out of 100 with higher scores indicating better usability	6 and 12 months
Secondary	Acceptability	Acceptability and usability feedback from semi-structured interviews	3, 6, and 12 months
Secondary	System use and compliance	Data collected via the system about users engagement with the system (e.g. number of times accessed, length of time accessed, features used)	Throughout 12 months
Secondary	Engagement	Qualitative feedback from participants	3, 6, and 12 months
Secondary	Costs	Cost analysis will be used to examine the factors impacting costs for implementing the system	Throughout 12 months