Patient Engagement Investigation of NMS Assist
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNewcastle University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Secondary cause of Parkinsonism
Significant cognitive impairment or a diagnosis of Parkinson's disease dementia
Trial design
Design model
Single group
Treatments tested in this trial
NMS Assist
DeviceThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: NMS AssistExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed throughout the 6-month study durationSecondary outcomes
1
Presence of non-motor symptoms
Measured using the Non-Motor Symptoms Questionnaire (NMSQ), patients tick 'yes' or 'no' for each symptom listed
Time frame
Measured monthly for 6 months2
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
Time frame
Assessed monthly for 6 months3
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
Time frame
Measured at baseline, 3, and 6 months4
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
Time frame
Measured at baseline, 3, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov