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

NCT04695353 | Completed

• 1 other identifier: CEIC-2299
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parkinson Disease

Keywords

telemedicine; Cost-effectiveness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Cost-effectiveness

  1 year

Study Arms (2)

Study group

EXPERIMENTAL

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

Procedure: Telemedicine: Virtual visits (videoconferences, texts)

Control group

NO INTERVENTION

The patients will receive in-office clinical care

Interventions

Telemedicine: Virtual visits (videoconferences, texts) PROCEDURE

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

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Burgos: lead

Study Sites (1)

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator

Model Details: International, longitudinal, case-control study comparing in-office visits to virtual visits via Telecommunication Platforms.

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: February 28, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)