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NCT Number: NCT07038486

Patient Engagement Investigation of NMS Assist

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE4 8EA, United Kingdom

Location status: Recruiting

Location contact

Cen

CONTACT

Edward Meinert, PhD

CONTACT

[email protected]

01912083811

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: Assessed throughout the 6-month study duration

    The primary outcome will be assessed using a composite of variables: recruitment, retention, system uptime, adherence/engagement, technical issues, and a review of the health and well-being outcomes (secondary outcomes).

    Adherence/engagement will be measured using system use data (trend of use over time). This will be supplemented with semi-structured interviews and a user engagement questionnaire to gain a better understanding of users' experience engaging with the intervention and the recommended behaviours. Technical issues will be identified through system use data (including logs of complaints made by participants during the intervention delivery period) as well as asking participants about any technical issues encountered during the semistructured interviews. Product complaints will be collected through feedback recorded via the platform, collected at study assessment points or manually provided via email throughout the study duration.

Secondary outcomes

  1. Presence of non-motor symptoms

    Time frame: Measured monthly for 6 months

    Measured using the Non-Motor Symptoms Questionnaire (NMSQ), patients tick 'yes' or 'no' for each symptom listed

  2. Patient (and care partner) activation

    Time frame: Assessed monthly for 6 months

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

  3. Frequency and severity of non-motor symptoms

    Time frame: Measured at baseline, 3, and 6 months

    Measured using the Movement Disorder Society Non-Motor Symptoms Scale (MDS-NMS), where higher scores indicate greater frequency and/or severity

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

    Time frame: Measured at baseline, 3, and 6 months

    Measured using the long-form Parkinson's Disease Questionnaire PDQ-39, patients indicate the frequency with which they experience certain issues

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

    Time frame: Measured monthly for 6 months

    Measured using the short-form Parkinson's Disease Questionnaire (PDQ-8), patients indicate the frequency with which they experience certain issues

  6. Carer well-being and quality of life

    Time frame: Measured monthly for 6 months

    Measured using the Parkinson Disease Questionnaire for care partners; care partners indicate the frequency with which they experience certain issues

  7. Health status

    Time frame: Measured at baseline, 3, and 6 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

  8. Adverse events

    Time frame: Throughout the 6-month study period

    Adverse event reporting

  9. Healthcare contacts

    Time frame: Throughout the 6-month study period

    Number of PwP-initiated contacts with healthcare team (through the 'request healthcare contact' feature) recorded by the system

  10. Quantitative usability

    Time frame: 3 and 6 months

    Using the mHealth app usability questionnaire (MAUQ) with higher scores indicating better usability

  11. Acceptability

    Time frame: 3 and 6 months

    Acceptability and usability feedback from semi-structured interviews

  12. Costs will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI)

    Time frame: Throughout 6 months

    Cost analysis will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI) for Parkinson's disease. The scale will be administered at 3 and 6 months.

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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