Parkinson DiseaseNCT04695353
Study of Feasibility and Efficacy of Telecommunication Platforms as an Adjunctive Clinical Tool for a Parkinson's Disease Clinic
A study testing Telemedicine: Virtual visits (videoconferences, texts) in people with Parkinson Disease, run by Hospital Universitario de Burgos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Telemedicine: Virtual visits (videoconferences, texts)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with idiopathic Parkinson´s disease, able to use a smart phone and running videoconferences, with easy access to wifi.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Telemedicine: Virtual visits (videoconferences, texts)
- Keywords
- telemedicine, Cost-effectiveness
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine: Virtual visits (videoconferences, texts)Procedure or surgery
Patients will receive clinical care by using telemedicine (virtual visits)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | These patients will receive telemedicine by using Telecommunication Platform videoconferences/messages. Receives: Procedure: Telemedicine: Virtual visits (videoconferences, texts) |
| Control group | No intervention | The patients will receive in-office clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 year
Patients and providers satisfaction and difficulties
description and comparison of the main difficulties and overall satisfaction between virtual vs. in-office visits
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start28 Feb 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- International, longitudinal, case-control study comparing in-office visits to virtual visits via Telecommunication Platforms.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Cubo, Hospital Universitario de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695353
- Sponsor's protocol ID
- CEIC-2299
- Status last verified
- May 2024
- First submitted
- 30 Dec 2020
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Feasibility and Efficacy of Telecommunication Platforms as an Adjunctive Clinical Tool for a Parkinson's Disease Clinic
- ClinicalTrials.gov ID
- NCT04695353
- Acronym / sponsor ID
- CEIC-2299
- Conditions
- Parkinson Disease
- Keywords
- telemedicine, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Universitario de BurgosUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- International, longitudinal, case-control study comparing in-office visits to virtual visits via Telecommunication Platforms.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Telemedicine: Virtual visits (videoconferences, texts)These patients will receive telemedicine by using Telecommunication Platform videoconferences/messages. |
| Control group | No intervention | –The patients will receive in-office clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with idiopathic Parkinson´s disease, able to use a smart phone and running videoconferences, with easy access to wifi.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine: Virtual visits (videoconferences, texts)Patients will receive clinical care by using telemedicine (virtual visits) | Procedure or surgery | Study group |
Primary outcome
Feasibility of Virtual Visits for Parkinson Disease
Time frame: 1 year
number of scheduled in-office and virtual visits that are completed, overall as well as by center, gender, and age-group.
Clinical management Complexity
Time frame: 1 year
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
Time frame: 1 year
description and comparison of the main difficulties and overall satisfaction between virtual vs. in-office visits
1 secondary outcome
Cost-effectiveness
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine: Virtual visits (videoconferences, texts) in people with Parkinson Disease, run by Hospital Universitario de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Virtual Visits for Parkinson Disease (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.