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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695353
• Other study ID #: CEIC-2299
• Status: Completed
• Phase: N/A
• Start date: February 28, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2024
• Source: Hospital Universitario de Burgos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Telemedicine: Virtual visits (videoconferences, texts)
Patients will receive clinical care by using telemedicine (virtual visits)

Locations

Country	Name	City	State
Spain	Hospital Universitario de Burgos	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Burgos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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