Clinical trial NCT05414071: Clinical Investigation of NMS Assist
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson
Keywords: Parkinson Disease
Self-Management
Telemedicine
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Patient (and care partner) activation
timeFrame: Assessed monthly for 12 months
Secondary outcomes:
measure: Presence of non-motor symptoms
timeFrame: Measured at patients' discretion throughout intervention (12 months)
measure: Frequency and severity of non-motor symptoms
timeFrame: Measured at baseline, 6, and 12 months
measure: Short-form self-assessment of functioning and well-being related to Parkinson's disease
timeFrame: Measured at patients' discretion throughout intervention (12 months)
measure: Long-form self-assessment of functioning and well-being related to Parkinson's disease
timeFrame: Measured at baseline, 6, and 12 months
measure: Carer well-being and quality of life
timeFrame: Measured at care partners' discretion throughout intervention (12 months)
measure: Health status
timeFrame: Measured at baseline, 6, and 12 months
measure: Mental well-being
timeFrame: Measured at baseline, 6, and 12 months
measure: Adverse events
timeFrame: Throughout 12 months
measure: Clinical safety
timeFrame: Throughout 12 months
measure: Healthcare contacts
timeFrame: Throughout 12 months
measure: Technical and implementation issues
timeFrame: Throughout 12 months
measure: Quantitative usability
timeFrame: 6 and 12 months
measure: Acceptability
timeFrame: 3, 6, and 12 months
measure: System use and compliance
timeFrame: Throughout 12 months
measure: Engagement
timeFrame: 3, 6, and 12 months
measure: Costs
timeFrame: Throughout 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.