Patient Engagement Investigation of NMS Assist
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NMS Assist.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of a Digital System on the Monitoring and Self-management of Non-motor Symptoms in People With Parkinson's
Overview
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 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 30 PwP and CPs to use the digital tool for 6 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 participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development. 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 healthcare professionals on manageable non-motor symptoms.
Interventions
- 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 reques
Primary outcome measures
- Feasibility of the intervention [Time frame: Assessed throughout the 6-month study duration]
Secondary outcome measures (12)
- Presence of non-motor symptoms [Time frame: Measured monthly for 6 months]
- Patient (and care partner) activation [Time frame: Assessed monthly for 6 months]
- Frequency and severity of non-motor symptoms [Time frame: Measured at baseline, 3, and 6 months]
- Long-form self-assessment of functioning and well-being related to Parkinson's disease [Time frame: Measured at baseline, 3, and 6 months]
- Short-form self-assessment of functioning and well-being related to Parkinson's disease [Time frame: Measured monthly for 6 months]
- Carer well-being and quality of life [Time frame: Measured monthly for 6 months]
- Health status [Time frame: Measured at baseline, 3, and 6 months]
- Adverse events [Time frame: Throughout the 6-month study period]
- Healthcare contacts [Time frame: Throughout the 6-month study period]
- Quantitative usability [Time frame: 3 and 6 months]
- Acceptability [Time frame: 3 and 6 months]
- Costs will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI) [Time frame: Throughout 6 months]
Eligibility criteria
Inclusion Criteria: Individuals will be eligible if they meet the following inclusion criteria:
All:
- Age 18 years or over
- Have compatible smartphone/data access (access to a digital device is a necessary prerequisite of system use, and the formative usability study had success in recruiting participants with varying levels of experience with smartphones)
- Be fluent in English
- Able and willing to provide informed consent
- Able and willing to comply with intervention requirements
For clinically diagnosed people with Parkinson's (PwP) (ICD-10-CM G20):
- Not resident in a care home or nursing home
- Ambulant
- Interested in monitoring and managing their NMS
For CPs:
\- Be caring for a clinically diagnosed PwP (ICD-10-CM G20) who is participating in the study
Exclusion Criteria: Participants will be ineligible for the study if they meet any of the following exclusion criteria:
All:
- Previous involvement in the development or testing of the digital system
- In a dependent/unequal relationship with the research or care teams or any PPI representatives
PwP:
- Secondary cause of Parkinsonism
- Significant cognitive impairment or a diagnosis of Parkinson's disease dementia
- Significant comorbidity, which, in the opinion of the chief investigator, would preclude safe participation in the study or protocol compliance
- A life expectancy of <6 months
- Living in residential care facilities
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United Kingdom · 1 center
- Newcastle University — Newcastle upon Tyne
Identifiers
NCT: NCT07038486 · 202425 16 Caroll · H-2101