Multicenter Implementation of E-monitoring in Parkinson's Disease

Summary

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.

Conditions

• Parkinson Disease

Interventions

COMBINATION_PRODUCT

Sanacoach Parkinson (SCP)

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.

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Zuyderland Medisch Centrum

  lead OTHER

Principal Investigators

• Gerrit Tissingh, MD, PhD · Zuyderland MC

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-23

Primary Completion

2025-05-15

Completion

2025-06-27

Countries

• Netherlands

Study Locations