Patient Engagement Investigation of NMS Assist

Официальное название

The Impact of a Digital System on the Monitoring and Self-management of Non-motor Symptoms in People With Parkinson's

Обзор

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.

Вмешательства

• Устройство NMS Assist
  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 reques

Первичные конечные точки

• Feasibility of the intervention [Срок оценки: Assessed throughout the 6-month study duration]

Вторичные конечные точки (12)

• Presence of non-motor symptoms [Срок оценки: Measured monthly for 6 months]
• Patient (and care partner) activation [Срок оценки: Assessed monthly for 6 months]
• Frequency and severity of non-motor symptoms [Срок оценки: Measured at baseline, 3, and 6 months]
• Long-form self-assessment of functioning and well-being related to Parkinson's disease [Срок оценки: Measured at baseline, 3, and 6 months]
• Short-form self-assessment of functioning and well-being related to Parkinson's disease [Срок оценки: Measured monthly for 6 months]
• Carer well-being and quality of life [Срок оценки: Measured monthly for 6 months]
• Health status [Срок оценки: Measured at baseline, 3, and 6 months]
• Adverse events [Срок оценки: Throughout the 6-month study period]
• Healthcare contacts [Срок оценки: Throughout the 6-month study period]
• Quantitative usability [Срок оценки: 3 and 6 months]
• Acceptability [Срок оценки: 3 and 6 months]
• Costs will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI) [Срок оценки: Throughout 6 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 1 центр

• Newcastle University — Newcastle upon Tyne

Идентификаторы

NCT: NCT07038486 · 202425 16 Caroll · H-2101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗