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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Telemedicine: Virtual visits (videoconferences, texts)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; These patients will receive telemedicine by using Telecommunication Platform videoconferences/messages.	Procedure: Telemedicine: Virtual visits (videoconferences, texts); Patients will receive clinical care by using telemedicine (virtual visits)
No Intervention: Control group; The patients will receive in-office clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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	1 year
Patients and providers satisfaction and difficulties	description and comparison of the main difficulties and overall satisfaction between virtual vs. in-office visits	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Hospital Universitario de Burgos

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2021
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: telemedicine; Cost-effectiveness
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CEIC-2299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No