Digitised Home Based Care for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Digitised Home Based Care for Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05544305
• Other study ID #: PEOS-3289
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2023
• Source: University of Plymouth
• Contact: Edward Meinert, PhD
• Phone: 01752600600
• Email: edward.meinert[@]plymouth.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Parkinson's disease is the world's fastest-growing neurological condition. It is a progressive neurodegenerative disorder that causes a wide range of movement-related (motor) problems (slowness, stiffness, tremor, balance difficulties) and non-motor problems (disturbances of thinking, memory, perception, mood, bladder, bowels, blood pressure). Even before the pandemic, NHS services were struggling to meet the demand for care. To address this need for support, the investigators have co-designed an innovative digital care pathway, Home Based Care (HBC), with people with Parkinson's (PwP) and care partners (CP) to deliver self-management support and clinical expertise to the patient's home. This pathway is supported by remote monitoring with a wrist-worn sensor and questionnaires. In this study, the investigators will be digitising this pathway so that data from a variety of sources (including the sensor, questionnaires, and patients' health records) can be combined in one place to enable more personalised care and to provide advice to support self-management of symptoms by patients. After the investigators have set up the digitised pathway, its implementation will be evaluated with a group of 120 people with Parkinson's and their care partners and associated healthcare providers through the Plymouth Parkinson's Service. The investigators will examine participants' adoption of and engagement with the patient-facing digital platform over the course of 3 months and gather their feedback about its usability and acceptability. 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. The investigators anticipate that this system will result in improved quality of life and care and increased knowledge and confidence for self-managing symptoms. The results of the study will be used to improve the digitised Home Based Care pathway. People with Parkinson's and care partners involved in the project will help guide the sharing of these results with healthcare providers and the general public.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or over
• Not resident in care home or nursing home
• Ambulant
• 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 [18])
• Be fluent in English
• Normally under the care of the Parkinson's service in the participating organisation
• Participant's healthcare provider in the participating organisation consented to participate in the study
• Able and willing to provide informed consent
• Able and willing to comply with intervention requirements

Exclusion Criteria:

• 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
• Previous involvement in development or testing of the NMS Assist system
• A life expectancy of <6 months
• Living in residential care facilities
• Incapable of self-consent
• In a dependent/unequal relationship with the research or care teams or any PPI representatives

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

Other:
• Digital Home Based Care pathway
The digital version of the pathway includes an integrated data platform with an automated patient flow management system, digitised patient-reported outcome on web-based patient portal, and AI-based automated reporting for clinical decision support.

Locations

Country	Name	City	State
United Kingdom	University of Plymouth	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake	Rates of conversion to the digital platform	3 months
Primary	Degree of compliance with wearable sensor	The wearable sensors are worn on the wrist and are known as the Parkinson's Kinetograph (PKG). The PKG assess objective motor measures including bradykinesia, dyskinesia and tremor. In accordance with the HBC pathway, patients are required to wear the PKG for 6 days and nights, after which the results are analyzed by their care team. From these results, therefore, it is clear to see where the patient has complied with wearing the PKG for the allotted time frame.	3 months
Primary	Proportion of digital questionnaires completed	In accordance with HBC pathway, patients are required to complete a set of questionnaires covering the same time period in which they are wearing the PKG, and are responsible for assessing subjective measures. This outcome will assess compliance by examining the patients' overall compliance with the digital monitoring questionnaires by calculating how many of the questionnaires they successfully complete over the study period.	3 months
Primary	Engagement	Qualitative feedback about engagement from semi-structured interviews	3 months
Secondary	Usability scores	System Usability Scale, 5-point Likert scale with total scores ranging from 0-100	3 months
Secondary	Patient perceptions of usability	Qualitative feedback about usability from semi-structured interviews	3 months
Secondary	Patient perceptions of acceptability	Qualitative feedback about acceptability from semi-structured interviews	3 months
Secondary	Cost impact	Preliminary evaluation of implementation costs; costs required to implement the digital HBC pathway will be compared to the costs of delivering the standard care pathway	3 months