Multicenter Implementation of E-monitoring in Parkinson's Disease

Study Overview
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Brief Summary
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Introduction and rationale: Parkinson´s disease (PD) is a slowly progressive and chronic disease, characterized by a range of motor and non-motor symptoms such as bradykinesia, tremor and falls, but also sleep disturbance, cognitive decline, behavioral problems and autonomic failure. These symptoms often fluctuate over time and between patients. These fluctuating and often debilitating symptoms necessitate proper monitoring. Due to this complexity, most patients require long-term specialized care. The current prevalence of PD in the Netherlands is estimated at 600-775 per 100.000 persons. This figure is expected to increase with > 50% in 2040. Combined with rising healthcare costs and a projected reduction in the number of available healthcare professionals, a system of frequent outpatient visits with a movement disorder specialist, as is currently the standard of care for PD in most (Dutch) hospitals, will likely not be sustainable. Additionally, improvements can be made in the quality of care for PD-patients. The most important aspect mentioned by patients is improved self-management. Other points of improvement are: communication between different healthcare professionals involved; advanced care planning and having a single point of access / personal case manager. Recently an international group of experts in the field of PD have published a viewpoint article concerning their ideas for the optimization of the care for PD-patients. In addition to the previous points, these experts mention: providing care at home rather than in hospital; pro-active instead of reactive care and improvement of the expertise of healthcare professionals. A possible solution to improving the sustainability of care for PD-patients, and addressing several of the issues concerning quality of care, lies in the use of telemedicine (or eHealth): the remote diagnosis and treatment of patients by means of telecommunications technology. Telemedicine exists in a wide variety of forms, one of which is 'telemonitoring'; the home monitoring of patients. In 2017 it was shown that telemonitoring is save and led to a significant reduction in health care consumption in patients with inflammatory bowel disease. Furthermore, studies in several chronic diseases have shown that telemonitoring leads to better patient empowerment and improved self-management. Self-management is in itself associated with improved health status and well-being in patients with a chronic disease as well as with a reduction in healthcare consumption. In collaboration with Sananet, Zuyderland Medical Center has developed a telemonitoring tool for PD called 'SanaCoach Parkinson' (SCP). It is, to the investigators knowledge, the first telemonitoring tool for PD that uses anamnestic data from targeted questionnaires to monitor patients with PD. Trough the SCP both motor and non-motor aspects of PD are screened pro-actively. It allows patients to remain at home rather that visit the outpatient clinic. Additionally, proactive monitoring of symptoms leads to earlier detection of deterioration. This gives the neurologist the possibility to optimize (medical) treatment before further, costly, complications arise. Furthermore, the SCP improves patients' insight in their disease, supporting self-management. A previous pilot-study into the effect of implementation of this tool showed that the use of the SCP was feasible in an outpatient care setting and that patient satisfaction and experienced quality of care were high. Additionally, the use of the SCP led to a significant reduction in the number of outpatient visits as well as the PD-related healthcare costs in Zuyderland Medical Center in the first year of use of the SCP. Hypotheses: The investigators hypothesize that implementation of telemonitoring via the SCP will be non-inferior to treatment as usual (TAU) with regards to the quality of care as experienced by PD-patients, while reducing the PD-related healthcare consumption and costs. Secondly the investigators hypothesize that telemonitoring via the SCP will improve the quality of care for PD-patients compared to TAU. Study Design and procedures: This will be a non-randomized, prospective, multi-center, non-inferiority, implementation study. During 1 year, all consecutive PD-patients in the neurology outpatient clinic of each participating hospital that meet the in- and exclusion criteria will be invited to join this study. Participants will be monitored via the SCP for 2 years. During this time, PD-related outpatient visits with either a neurologist of specialized nurse will be set at 1-2 per patient per year, with a maximum total planned duration of 60 minutes. If this is not feasible, the primary reason for this will be recorded. New hospitals may join the study until 6 months after the inclusion of the first patient. Assessments will take place at baseline, 1 year and 2 years.

Official Title
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Multicenter Implementation of E-monitoring in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Combination Product: Sanacoach Parkinson (SCP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease Disease duration ≥ 3 months. Able to complete the questionnaires and use the Sanacoach Parkinson, independently or with the help of an informal caregiver. Exclusion Criteria: Not able to understand and/or sign the informed consent. No access to the internet via computer, tablet or smartphone. Participating in other trial

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Implementation study with stepwise approach
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Intervention: use of SCP | Combination Product: Sanacoach Parkinson (SCP)<br>* A web-based monitoring tool for patients with PD, using questionnaires. It includes nine parts: 1) A 89-question, quarterly questionnaire about PD-symptoms. 2) Questionnaire responses are converted to scores on 16 PD-related domains. Both the current score and the score's change compared to the previous questionnaire are visible. 3) An interim evaluation is sent after 6 weeks with questions on any domains where a patient indicated problems. 4) A medication monitor can be initialized by the treating physician to evaluate the effect of a therapeutic change. 5) A consultation preparation module allows patients to indicate which topics they want to discuss during an outpatient visit. 6) Patients can ask for 'calling advise' if they are unsure whether to contact their physician. 7) Patients and healthcare providers can send each other text messages. 8) Interactive learning modules about PD. 9) Annual evaluation regarding patient satisfaction, self-management and healthcare consumption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-experienced quality of care | Measured by the net-promoter score. Each patient rates their care received on a scale of 0 to 10. Detractors (scoring 0-6) are subtracted from promoters (scoring 9-10), leaving the net-promoter score. The score ranges from -100 to +100, with higher scores indicating better patient-experienced quality of care. | Change between baseline and after two years of using the Sanacoach Parkinson | 
| Patient-satisfaction with the Sanacoach Parkinson | Measured by an 11-item patient satisfaction questionnaire. Score range = 1-45, with higher scores indicating better patient satisfaction. | Measured after 2 years of using the Sanacoach Parkinson | 
| Disease-related quality of life | Measured by the 8-item Parkinson's disease questionnaire (PDQ-8), range 0-32, higher scores indicate worse quality of life | Change between baseline and after two years of using the Sanacoach Parkinson | 
| Disease-related health care costs | Calculated by measuring the number of PD-relates visits, telephone contacts and e-mail contacts with a neurologist, specialized nurse or general practitioner; number of hospitalizations, hospitalization days and emergency room visits related to PD, head trauma, hip fracture, pneumonia or psychosis; number of visits to a physiotherapist, occupational therapist, speech therapist or psychologist; number of days receiving inpatient of outpatient care at a rehabilitation center or nursing home; hours of formal and informal care received, days of labor missed and time spent by neurologists and specialized nurses on monitoring the Sanacoach Parkinson and follow-up activities. All these variables will be converted to costs per year (in euros). | Change of average costs per year during the two years of using the Sanacoach Parkinson, compared to a 6 month period before use of the Sanacoach Parkinson | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-management | Measured by the Partners In Health scale, range 0-96, higher scores indicate better self-management | Change between baseline and after two years of using the Sanacoach Parkinson | 
| Caregiver burden | Measured by the Caregiver Strain Index, range 0-13, higher scores indicate higher caregiver burden | Change between baseline and after two years of using the Sanacoach Parkinson | 
| Disease-severity | Measured by the Unified Parkinson's Disease Rating Scale (UPDRS), range 0-260, higher scores indicate increased disease-severity | Change between baseline and after two years of using the Sanacoach Parkinson | 
| Healthcare professional's attitude towards the Sanacoach Parkinson | Measured by a 9-item questionnaire, range 0-36, higher scores indicate better satisfaction with the Sanacoach Parkinson | Measured 6-monthly during 3 years of working with the Sanacoach Parkinson | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Telemonitoring, Cost effectiveness, Quality of care, eHealth