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Parkinson DiseaseEPDNCT05164783

Multicenter Implementation of E-monitoring in Parkinson's Disease

A study testing Sanacoach Parkinson (SCP) in people with Parkinson Disease, run by Zuyderland Medisch Centrum at 6 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Sanacoach Parkinson (SCP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
6 sitesNetherlands
Study dates
23 Nov 2021to 27 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Not able to understand and/or sign the informed consent.
  • No access to the internet via computer, tablet or smartphone.
  • Participating in other trial

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites
  • Meander Medical Center

    Amersfoort

  • Onze Lieve Vrouwe Hospital

    Amsterdam

  • Rode Kruis Hospital

    Beverwijk

  • Zuyderland Medical Center

    Geleen

  • Zuyderland Medical Center

    Heerlen

  • Elkerliek Hospital

    Helmond

Other trials in Netherlands

About this study

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.

Read more

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.

Being tested
Sanacoach Parkinson (SCP)
Keywords
Parkinson's Disease, Telemonitoring, Cost effectiveness, Quality of care, eHealth
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sanacoach Parkinson (SCP)Combination product

    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.

Study groups in NCT05164783
Study groupRoleWhat they receive
ParticipantsExperimentalIntervention: use of SCP
Receives: Combination Product: Sanacoach Parkinson (SCP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change between baseline and after two years of using the Sanacoach Parkinson

  2. 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: Measured after 2 years of using the Sanacoach Parkinson

  3. 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

    Measured: Change between baseline and after two years of using the Sanacoach Parkinson

  4. 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).

    Measured: 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 outcomes (4)
  1. Patient self-management

    Measured by the Partners In Health scale, range 0-96, higher scores indicate better self-management

    Measured: Change between baseline and after two years of using the Sanacoach Parkinson

  2. Caregiver burden

    Measured by the Caregiver Strain Index, range 0-13, higher scores indicate higher caregiver burden

    Measured: Change between baseline and after two years of using the Sanacoach Parkinson

  3. Disease-severity

    Measured by the Unified Parkinson's Disease Rating Scale (UPDRS), range 0-260, higher scores indicate increased disease-severity

    Measured: Change between baseline and after two years of using the Sanacoach Parkinson

  4. 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: Measured 6-monthly during 3 years of working with the Sanacoach Parkinson

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2021
  2. Study start23 Nov 2021
  3. Primary completion15 May 2025
  4. Study completion27 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Implementation study with stepwise approach
Masking
None (open label)
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05164783
Sponsor's protocol ID
Z2021125
Acronym
EPD
Status last verified
Jun 2025
First submitted
28 Oct 2021
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28332488
  • Clarke CE. Parkinson's disease. BMJ. 2007 Sep 1;335(7617):441-5. doi: 10.1136/bmj.39289.437454.AD. No abstract available.

    PubMed 17762036
  • 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.

    PubMed 21832214
  • 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.

    PubMed 23054239
  • 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.

    PubMed 23436720
  • 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.

    PubMed 30373962
  • 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.

    PubMed 32464101
  • 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.

    PubMed 28716313
  • 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.

    PubMed 17233653
  • 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.

    PubMed 31293241
  • 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.

    PubMed 25677954
  • 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.

    PubMed 12401421
  • 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.

    PubMed 12867348
  • 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.

    PubMed 30601717
  • 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.

    PubMed 12435261

Questions about this trial

What is this clinical trial studying?

A study testing Sanacoach Parkinson (SCP) in people with Parkinson Disease, run by Zuyderland Medisch Centrum at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-experienced quality of care (time frame: Change between baseline and after two years of using the Sanacoach Parkinson). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05164783, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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