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ParkinsonNCT05414071

Clinical Investigation of NMS Assist

A study testing NMS Assist in people with Parkinson, run by University of Plymouth.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson
What is being tested?
NMS Assist
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2023to 1 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read more

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.

Conditions
Parkinson
Being tested
NMS Assist
Keywords
Parkinson Disease, Self-Management, Telemedicine
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NMS AssistDevice

    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.

Study groups in NCT05414071
Study groupRoleWhat they receive
NMS AssistExperimentalNMS 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.
Receives: Device: NMS Assist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Assessed monthly for 12 months

Secondary outcomes (16)

  1. Presence of non-motor symptoms

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

    Measured: Measured at patients' discretion throughout intervention (12 months)

  2. 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: Measured at baseline, 6, and 12 months

  3. 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: Measured at patients' discretion throughout intervention (12 months)

  4. 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: Measured at baseline, 6, and 12 months

  5. 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: Measured at care partners' discretion throughout intervention (12 months)

  6. 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: Measured at baseline, 6, and 12 months

  7. 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: Measured at baseline, 6, and 12 months

  8. Adverse events

    Adverse Event Reporting

    Measured: Throughout 12 months

  9. Clinical safety

    Record of any events missed

    Measured: Throughout 12 months

  10. 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

    Measured: Throughout 12 months

  11. Technical and implementation issues

    Technical issues identified from the system use data and by participants and process measures relating to service delivery

    Measured: Throughout 12 months

  12. Quantitative usability

    System Usability Scale, out of 100 with higher scores indicating better usability

    Measured: 6 and 12 months

  13. Acceptability

    Acceptability and usability feedback from semi-structured interviews

    Measured: 3, 6, and 12 months

  14. 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)

    Measured: Throughout 12 months

  15. Engagement

    Qualitative feedback from participants

    Measured: 3, 6, and 12 months

  16. Costs

    Cost analysis will be used to examine the factors impacting costs for implementing the system

    Measured: Throughout 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Why it stopped: The study sponsor has changed and is no longer the University of Plymouth. A new record is being created under the updated sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05414071
Sponsor's protocol ID
AM1000398
Status last verified
Jun 2025
First submitted
1 Jun 2022
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data belongs to the study sponsor (the University of Plymouth) and deidentified data will be made available in line with the data sharing policy developed with Parkinson's UK and PPI representatives.

Publications

  • 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.

    PubMed 36155396

Questions about this trial

What is this clinical trial studying?

A study testing NMS Assist in people with Parkinson, run by University of Plymouth.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient (and care partner) activation (time frame: Assessed monthly for 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05414071, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.

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