Study of Feasibility and Efficacy of Telecommunication Platforms as an Adjunctive Clinical Tool for a Parkinson's Disease Clinic
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemedicine: Virtual visits (videoconferences, texts)
Sponsored by
About this trial
This is an interventional health services research trial for Parkinson Disease focused on measuring telemedicine, Cost-effectiveness
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario de BurgosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm Description
These patients will receive telemedicine by using Telecommunication Platform videoconferences/messages.
The patients will receive in-office clinical care
Outcomes
Primary Outcome Measures
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.
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
Patients and providers satisfaction and difficulties
description and comparison of the main difficulties and overall satisfaction between virtual vs. in-office visits
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04695353
First Posted
December 30, 2020
Last Updated
March 19, 2021
Sponsor
Hospital Universitario de Burgos
1. Study Identification
Unique Protocol Identification Number
NCT04695353
Brief Title
Study of Feasibility and Efficacy of Telecommunication Platforms as an Adjunctive Clinical Tool for a Parkinson's Disease Clinic
Official Title
Study of Feasibility and Efficacy of Telecommunication Platforms as an Adjunctive Clinical Tool for a Parkinson's Disease Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Burgos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
telemedicine, Cost-effectiveness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
International, longitudinal, case-control study comparing in-office visits to virtual visits via Telecommunication Platforms.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
These patients will receive telemedicine by using Telecommunication Platform videoconferences/messages.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients will receive in-office clinical care
Intervention Type
Procedure
Intervention Name(s)
Telemedicine: Virtual visits (videoconferences, texts)
Intervention Description
Patients will receive clinical care by using telemedicine (virtual visits)
Primary Outcome Measure Information:
Title
Feasibility of Virtual Visits for Parkinson Disease
Description
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
Title
Clinical management Complexity
Description
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
Title
Patients and providers satisfaction and difficulties
Description
description and comparison of the main difficulties and overall satisfaction between virtual vs. in-office visits
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Cubo, MD, PhD
Phone
947256533
Ext
35380
Email
mcubo@saludcastillayleon.es
First Name & Middle Initial & Last Name or Official Title & Degree
Alvaro Garcia Bustillo, OT
Phone
947256533
Ext
35380
Email
alvarogarbu@gmail.com
Facility Information:
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Cubo, MD
Phone
+34947256533
Ext
35380
Email
mcubo@saludcastillayleon.es
First Name & Middle Initial & Last Name & Degree
Alvaro Garcia Bustillo, OT
Phone
+34947256533
Ext
35380
Email
alvarogarbu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Feasibility and Efficacy of Telecommunication Platforms as an Adjunctive Clinical Tool for a Parkinson's Disease Clinic
We'll reach out to this number within 24 hrs