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CompletedNCT04695353Updated May 16, 2024

Study of Feasibility and Efficacy of Telecommunication Platforms as an Adjunctive Clinical Tool for a Parkinson's Disease Clinic

An interventional study of Telemedicine: Virtual visits (videoconferences, texts) in Parkinson Disease, sponsored by Hospital Universitario de Burgos. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Hospital Universitario de Burgos · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Telecommunication Platforms are new technology founded to build better short messages service alternative. Their use have increasingly drawn a wider range of interest as a text communication and video chat system between health care professionals and patients and health care professionals themselves. However, high-quality and adequately evaluated research, especially in the field of neurodegenerative diseases such as Parkinson´s disease, is needed to establish whether patients with these specific neurological problems can be effectively managed with these technological tools in low, middle, and high-income countries

Read the detailed description

Telecommunication Platforms are new technology founded to build a better short message service alternative. Their use have increasingly drawn a wider range of interest as a text communication and video chat system between health care professionals and patients and health care professionals themselves. However, high-quality and adequately evaluated research, especially in the field of neurodegenerative diseases such as Parkinson´s disease, is needed to establish whether patients with these specific neurological problems can be effectively managed with these technological tools. In this study, patients with Parkinson´s disease from high, middle, and low-income countries covering urban and rural populations, with at least one neurologist with Movement Disorders practice (Spain, Uruguay, Saudi Arabia, Nigeria, Tanzania, South Korea, United States, Egypt), will be included. Feasibility, clinical management, providers and patient´s satisfaction will be compared between in-office vs. telemedicine (virtual) visits. This study will show the effectiveness of telemedicine, when the access to specialized neurological care is limited, especially now with the Covid-19 pandemic.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • telemedicine
  • Cost-effectiveness
03

In context

Parkinson Disease

4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 50 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Hospital Universitario de Burgos is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with idiopathic Parkinson´s disease, able to use a smart phone and running videoconferences, with easy access to wifi.

Exclusion criteria

Exclusion Criteria:

Patients with severe ambulatory problems that will interfere with in-office visits, without access to Internet, with limited technical knowledge unable to use Telecommunication Platforms, or patients diagnosed with other types of Parkinsonism.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Study group

    These patients will receive telemedicine by using Telecommunication Platform videoconferences/messages.

    Procedure: Telemedicine: Virtual visits (videoconferences, texts)

  • No intervention
    Control group

    The patients will receive in-office clinical care

Interventions

  • ProcedureTelemedicine: Virtual visits (videoconferences, texts)

    Patients will receive clinical care by using telemedicine (virtual visits)

06

What researchers measure

Primary outcomes

  1. Feasibility of Virtual Visits for Parkinson Disease

    number of scheduled in-office and virtual visits that are completed, overall as well as by center, gender, and age-group.

    Time frame: 1 year

  2. Clinical management Complexity

    Comparison of the clinical issues frequency (% of any of the following) performed during either virtual or in-office visits: the sum of pharmacological and non-pharmacological treatment recommendations, urgent clinical problem evaluation, discussion of test results, education, and second-opinion requests

    Time frame: 1 year

  3. Patients and providers satisfaction and difficulties

    description and comparison of the main difficulties and overall satisfaction between virtual vs. in-office visits

    Time frame: 1 year

Secondary outcomes

  1. Cost-effectiveness

    Comparison of costs (from a patient's perspective) at the end of the study vs. baseline (previous 6 months) in terms of medical (drugs, doctors and other health professionals, hospitalizations, non-pharmacological interventions, work-up tests), and non-medical (internet and cellular phone fee, travel costs related to health care, medical equipments such as canes, etc, caregiver and nursing home fees) costs between virtual and in-office visits

    Time frame: 1 year

07

Study locations

1 site
  • Hospital Universitario de Burgos
    Burgos, 09006, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04695353
Lead sponsor
Hospital Universitario de Burgos
Responsible party
Esther Cubo (MD, PhD, Principal Investigator, Hospital Universitario de Burgos) — Principal investigator
First posted
Jan 5, 2021
Start date
Feb 28, 2021
Primary completion
Jul 30, 2023
Completion
Jul 30, 2023
Last update
May 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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