Clinical Investigation of NMS Assist
- Conditions
- Parkinson
- Interventions
- Device: NMS Assist
- Registration Number
- NCT05414071
- Lead Sponsor
- University of Plymouth
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NMS Assist 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.
- Primary Outcome Measures
Name Time Method Patient (and care partner) activation Assessed monthly for 12 months Patient Activation Measure (and caregiver version) will be used to evaluate their confidence, knowledge, and skills at non-motor symptom self-management
- Secondary Outcome Measures
Name Time Method Adverse events Throughout 12 months Adverse Event Reporting
Quantitative usability 6 and 12 months System Usability Scale, out of 100 with higher scores indicating better usability
Presence of non-motor symptoms Measured at patients' discretion throughout intervention (12 months) Measured using the Non-Motor Symptoms Questionnaire (NMSQ), patients tick 'yes' or 'no' for each symptom listed
Frequency and severity of non-motor symptoms Measured at baseline, 6, and 12 months Measured using the Movement Disorder Society Non-Motor Symptoms Scale (MDS-NMS), where higher scores indicate greater frequency and/or severity
Mental well-being Measured at baseline, 6, and 12 months 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
Clinical safety Throughout 12 months Record of any events missed
Short-form self-assessment of functioning and well-being related to Parkinson's disease Measured at patients' discretion throughout intervention (12 months) Measured using the short-form Parkinson's Disease Questionnaire (PDQ-8), patients indicate the frequency with which they experience certain issues
Long-form self-assessment of functioning and well-being related to Parkinson's disease Measured at baseline, 6, and 12 months Measured using the long-form Parkinson's Disease Questionnaire PDQ-39, patients indicate the frequency with which they experience certain issues
Carer well-being and quality of life Measured at care partners' discretion throughout intervention (12 months) Measured using the Parkinson Disease Questionnaire for care partners; care partners indicate the frequency with which they experience certain issues
Health status Measured at baseline, 6, and 12 months 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
Engagement 3, 6, and 12 months Qualitative feedback from participants
Acceptability 3, 6, and 12 months Acceptability and usability feedback from semi-structured interviews
Healthcare contacts Throughout 12 months 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
Technical and implementation issues Throughout 12 months Technical issues identified from the system use data and by participants and process measures relating to service delivery
System use and compliance Throughout 12 months Data collected via the system about users engagement with the system (e.g. number of times accessed, length of time accessed, features used)
Costs Throughout 12 months Cost analysis will be used to examine the factors impacting costs for implementing the system