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

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ClinicalTrials.gov Identifier: NCT04695353
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Esther Cubo, Hospital Universitario de Burgos

Study Description
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Brief Summary:
WhatsApp is a relatively new technology platform founded to build a better short message service alternative. Its use has 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 this technological tool in low, middle, and high-income countries

Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: Telemedicine:WhatsApp messaging (videoconferences, texts) Not Applicable

Detailed Description:
WhatsApp is a relatively new technology platform founded to build a better short message service alternative. Its use has 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 this technological tool. 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 (WhatsApp) 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: International, longitudinal, case-control study comparing in-office visits to remote visits via WhatsApp Clinical Service
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study of Feasibility and Efficacy of WhatsApp as an Adjunctive Clinical Tool for a Parkinson's Disease Clinic
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
These patients will receive telemedicine by using WhatsApp.
 Procedure: Telemedicine:WhatsApp messaging (videoconferences, texts)
Patients will receive clinical care by using WhatsApp videoconferences
No Intervention: Control group
The patients will receive in-office clinical care


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of Virtual Visits for Parkinson Disease [ Time Frame: 1 year ]
    number of scheduled in-office and WhatsApp visits that are completed, overall as well as by center, gender, and age-group.

  2. Clinical management Complexity [ Time Frame: 1 year ]
    Comparison of the clinical issues frequency (% of any of the following) performed during either WhatsApp 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

  3. Patients and providers satisfaction and difficulties [ Time Frame: 1 year ]
    description and comparison of the main difficulties and overall satisfaction between virtual vs. in-office visits


Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 1 year ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 WhatsApp, with limited technical knowledge unable to use WhatsApp, or patients diagnosed with other types of Parkinsonism.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695353


Contacts
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Contact: Esther Cubo, MD, PhD 947256533 ext 35380 mcubo@saludcastillayleon.es
Contact: Alvaro Garcia Bustillo, OT 947256533 ext 35380 alvarogarbu@gmail.com

Locations
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Spain
Hospital Universitario de Burgos
Burgos, Spain, 09006
Sponsors and Collaborators
Hospital Universitario de Burgos
More Information
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Responsible Party: Esther Cubo, MD, PhD, Principal Investigator, Hospital Universitario de Burgos
ClinicalTrials.gov Identifier: NCT04695353    
Other Study ID Numbers: CEIC-2299
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esther Cubo, Hospital Universitario de Burgos:
telemedicine
Cost-effectiveness
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases