Patient Engagement Investigation of NMS Assist

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT07038486
• Lead Sponsor: Newcastle University

Brief 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). 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-07
• Primary Completion: 2026-03
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	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 Outcome Measures

Name	Time	Method
Frequency and severity of non-motor symptoms	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
Costs will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI)	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.
Long-form self-assessment of functioning and well-being related to Parkinson's disease	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
Short-form self-assessment of functioning and well-being related to Parkinson's disease	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
Carer well-being and quality of life	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
Health status	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
Adverse events	Throughout the 6-month study period	Adverse event reporting
Healthcare contacts	Throughout the 6-month study period	Number of PwP-initiated contacts with healthcare team (through the 'request healthcare contact' feature) recorded by the system
Quantitative usability	3 and 6 months	Using the mHealth app usability questionnaire (MAUQ) with higher scores indicating better usability
Acceptability	3 and 6 months	Acceptability and usability feedback from semi-structured interviews
Presence of non-motor symptoms	Measured monthly for 6 months	Measured using the Non-Motor Symptoms Questionnaire (NMSQ), patients tick 'yes' or 'no' for each symptom listed
Patient (and care partner) activation	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