Parkinson DiseaseNCT07038486
Patient Engagement Investigation of NMS Assist
A study testing NMS Assist in people with Parkinson Disease, run by Newcastle University at 1 site in United Kingdom.
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 Disease
- 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
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE4 8EA
Edward Meinert, PhD, 01912083811, depth.ai@newcastle.ac.uk
Cen
About this study
Official title: The Impact of a Digital 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 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.
Read more
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.
- Conditions
- Parkinson Disease
- Being tested
- NMS Assist
- Keywords
- Parkinson disease, Self-management, mhealth, mobile apps, 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 group | Role | What they receive |
|---|---|---|
| NMS Assist | Experimental | 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. Receives: Device: NMS Assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
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.
Measured: Assessed throughout the 6-month study duration
Secondary outcomes (12)
Presence of non-motor symptoms
Measured using the Non-Motor Symptoms Questionnaire (NMSQ), patients tick 'yes' or 'no' for each symptom listed
Measured: Measured monthly for 6 months
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 6 months
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, 3, and 6 months
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, 3, and 6 months
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 monthly for 6 months
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 monthly for 6 months
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, 3, and 6 months
Adverse events
Adverse event reporting
Measured: Throughout the 6-month study period
Healthcare contacts
Number of PwP-initiated contacts with healthcare team (through the 'request healthcare contact' feature) recorded by the system
Measured: Throughout the 6-month study period
Quantitative usability
Using the mHealth app usability questionnaire (MAUQ) with higher scores indicating better usability
Measured: 3 and 6 months
Acceptability
Acceptability and usability feedback from semi-structured interviews
Measured: 3 and 6 months
Costs will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI)
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.
Measured: Throughout 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start6 Aug 2025
- Primary completionSep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Meinert, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038486
- Sponsor's protocol ID
- 202425 16 Caroll
- Other IDs
- H-2101
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2025
- Last updated
- 8 Jan 2026
- 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 (Newcastle University) and deidentified data will be made available in line with the data sharing policy developed with Parkinson's UK and PPI representatives.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Digital System on the Monitoring and Self-management of Non-motor Symptoms in People With Parkinson's
- ClinicalTrials.gov ID
- NCT07038486
- Acronym / sponsor ID
- 202425 16 Caroll
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Self-management, mhealth, mobile apps, telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMS Assist | Experimental | Device: NMS AssistNMS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMS AssistThe 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. | Device | NMS Assist |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided. Data belongs to the study sponsor (Newcastle University) and deidentified data will be made available in line with the data sharing policy developed with Parkinson's UK and PPI representatives.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMS Assist in people with Parkinson Disease, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: Assessed throughout the 6-month study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.