Multicenter Implementation of E-monitoring in Parkinson's Disease

Parkinson Disease Clinical Trial

— EPD  

Official title:

Multicenter Implementation of E-monitoring in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05164783
• Other study ID #: Z2021125
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 258
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Meander Medical Center	Amersfoort
Netherlands	Onze Lieve Vrouwe Hospital	Amsterdam
Netherlands	Rode Kruis Hospital	Beverwijk
Netherlands	Zuyderland Medical Center	Geleen
Netherlands	Zuyderland Medical Center	Heerlen
Netherlands	Elkerliek Hospital	Helmond

Sponsors (2)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum	AbbVie

Country where clinical trial is conducted

Netherlands, 

References & Publications (17)

Allegrante JP, Wells MT, Peterson JC. Interventions to Support Behavioral Self-Management of Chronic Diseases. Annu Rev Public Health. 2019 Apr 1;40:127-146. doi: 10.1146/annurev-publhealth-040218-044008. Epub 2019 Jan 2. — View Citation

Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient Educ Couns. 2002 Oct-Nov;48(2):177-87. doi: 10.1016/s0738-3991(02)00032-0. — View Citation

Bloem BR, Henderson EJ, Dorsey ER, Okun MS, Okubadejo N, Chan P, Andrejack J, Darweesh SKL, Munneke M. Integrated and patient-centred management of Parkinson's disease: a network model for reshaping chronic neurological care. Lancet Neurol. 2020 Jul;19(7):623-634. doi: 10.1016/S1474-4422(20)30064-8. Epub 2020 May 25. — View Citation

Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469. — View Citation

Clarke CE. Parkinson's disease. BMJ. 2007 Sep 1;335(7617):441-5. doi: 10.1136/bmj.39289.437454.AD. No abstract available. — View Citation

de Jong MJ, van der Meulen-de Jong AE, Romberg-Camps MJ, Becx MC, Maljaars JP, Cilissen M, van Bodegraven AA, Mahmmod N, Markus T, Hameeteman WM, Dijkstra G, Masclee AA, Boonen A, Winkens B, van Tubergen A, Jonkers DM, Pierik MJ. Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial. Lancet. 2017 Sep 2;390(10098):959-968. doi: 10.1016/S0140-6736(17)31327-2. Epub 2017 Jul 14. — View Citation

Jalil S, Myers T, Atkinson I. A meta-synthesis of behavioral outcomes from telemedicine clinical trials for type 2 diabetes and the Clinical User-Experience Evaluation (CUE). J Med Syst. 2015 Mar;39(3):28. doi: 10.1007/s10916-015-0191-9. Epub 2015 Feb 13. — View Citation

Jie L, Jie A, Hoff J, Tissingh G. Telemonitoring verbetert parkinsonzorg. Medisch Contact. 2016; 14:7

Kowal SL, Dall TM, Chakrabarti R, Storm MV, Jain A. The current and projected economic burden of Parkinson's disease in the United States. Mov Disord. 2013 Mar;28(3):311-8. doi: 10.1002/mds.25292. Epub 2013 Feb 21. — View Citation

Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01. — View Citation

Poewe W, Seppi K, Tanner CM, Halliday GM, Brundin P, Volkmann J, Schrag AE, Lang AE. Parkinson disease. Nat Rev Dis Primers. 2017 Mar 23;3:17013. doi: 10.1038/nrdp.2017.13. — View Citation

Qian W, Lam TT, Lam HHW, Li CK, Cheung YT. Telehealth Interventions for Improving Self-Management in Patients With Hemophilia: Scoping Review of Clinical Studies. J Med Internet Res. 2019 Jul 10;21(7):e12340. doi: 10.2196/12340. — View Citation

Vlaanderen FP, Rompen L, Munneke M, Stoffer M, Bloem BR, Faber MJ. The Voice of the Parkinson Customer. J Parkinsons Dis. 2019;9(1):197-201. doi: 10.3233/JPD-181431. — View Citation

Wijers A, Hochstenbach L, Tissingh G. Telemonitoring via Questionnaires Reduces Outpatient Healthcare Consumption in Parkinson's Disease. Mov Disord Clin Pract. 2021 Jul 19;8(7):1075-1082. doi: 10.1002/mdc3.13280. eCollection 2021 Oct. — View Citation

Wilde MH, Garvin S. A concept analysis of self-monitoring. J Adv Nurs. 2007 Feb;57(3):339-50. doi: 10.1111/j.1365-2648.2006.04089.x. Erratum In: J Adv Nurs. 2007 Jun;58(6):616. — View Citation

Willis AW, Schootman M, Evanoff BA, Perlmutter JS, Racette BA. Neurologist care in Parkinson disease: a utilization, outcomes, and survival study. Neurology. 2011 Aug 30;77(9):851-7. doi: 10.1212/WNL.0b013e31822c9123. Epub 2011 Aug 10. — View Citation

Willis AW, Schootman M, Tran R, Kung N, Evanoff BA, Perlmutter JS, Racette BA. Neurologist-associated reduction in PD-related hospitalizations and health care expenditures. Neurology. 2012 Oct 23;79(17):1774-80. doi: 10.1212/WNL.0b013e3182703f92. Epub 2012 Oct 10. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance with Sanacoach Parkinson	Number of periodic questionnaires completed, patients completing <3 questionnaires a year are defined as non-compliant	During the 2 years of using the Sanacoach Parkinson
Other	Number of patients requiring additional outpatient visits	% of patient years in which a patient requires more than 2 outpatient visits	During the 2 years of using the Sanacoach Parkinson
Other	Reasons for additional outpatient visits	Descriptive summary of the reasons patient required additional outpatient visits, as specified by healthcare providers. Pre-specified options are: 1) Doctor-initiated, physical examination needed 2) Doctor-initiated, deepen history 3) Doctor-initiated, nature of problem 4) Patient-initiated and 5) Caregiver-initiated	During the 2 years of using the Sanacoach Parkinson
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Information on the epidemiology of Parkinson's Disease in the Netherlands, from the 'Rijksinstituut voor Volksgezondheid en Milieu' (RIVM), the Dutch National Institute for Health and Environment
•   Report on demographic changes in the Netherlands from 2010 to 2040, by the 'Planbureau voor de Leefomgeving', the Dutch national institute for strategic policy analysis in the field of environment, nature and space