Parkinson DiseaseTeleFallNCT04694443
Multidisciplinary Home-based Tele-rehabilitation Intervention
A study testing Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist) and Standard in-office medical care in people with Parkinson Disease, run by Esther Cubo at 1 site in Spain.
Trial summary
Falls in Parkinson's Disease (PD) are very frequent with often devastating consequences, increasing comorbidity, mortality, decreased quality of life and increased socio-health costs. 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?
- Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist) and Standard in-office medical care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 31 Dec 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
- Non-demented patients
- Patients diagnosed with idiopathic Parkinson´s disease
- Patients able to walk with a Hoehn Yahr stage < 3
Who cannot join
- Non-ambulatory patients with Parkinson´s disease
- Patients diagnosed with significant comorbidity (psychiatric, systemic, hearing or visual disturbances) according to the investigator criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Cost-effectiveness of a Multidisciplinary Home-based Telehealth Intervention Program to Reduce Falls in Parkinson´s Disease (TeleFall).
Falls in Parkinson's Disease (PD) are very frequent with often devastating consequences, increasing comorbidity, mortality, decreased quality of life and increased socio-health costs. In this national, single-center, single-blind, randomized, case-control study, non-demented patients with idiopathic PD with high risk of falling will be included. The main objective of this study is to determine the cost-effectiveness of a home-based, multidisciplinary tele-health intervention to decrease the risk of falling.
Read the detailed description
In this study, PD patients using multidisciplinary tele-health intervention (study group) will be compared to age, gender-matched PD patients receiving the best standard in-office clinical management (control group). Both groups will be followed for 8 months.
The main outcome will be the comparison of incidence of falls between the study and control groups. Secondary outcomes will include the analysis of cost-effectiveness of multidisciplinary tele-health interventions.
The results of this study will allow us to study the feasibility of remote health care to prevent falls in patients with PD, allowing equity in the distribution and access to specialized health care.
- Conditions
- Parkinson Disease
- Being tested
- Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist), Standard in-office medical care
- Keywords
- Falls, Cost-effectiveness, Qaly
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)Procedure or surgery
Also called Education
Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits
Standard in-office medical careOther
Non-pharmacological and pharmacological treatment provided in-office visits
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | The study group will receive the multidisciplinary tele-health intervention plus standard medical care Receives: Procedure: Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist) |
| Control group | Placebo comparator | The control group will receive the best standard medical care Receives: Other: Standard in-office medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of falls reduction
Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors
Measured: 8 months
Feasibility
Number of virtual videoconferences completed
Measured: 8 months
Secondary outcomes (2)
Cost-effectiveness
To compare the medical and non-medical direct costs between the study and control groups by using structured questionnaires
Measured: 8 months
Healt-related quality of life
To compare the PDQ-39 scores between the study and control groups
Measured: 8 months
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 start1 Jan 2020
- Primary completion30 Oct 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind, randomized, case-control study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esther Cubo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Burgos, Instituto de Salud Carlos III, University of Burgos
- Responsible party
- Sponsor-investigator, Esther Cubo, Hospital Universitario de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694443
- Sponsor's protocol ID
- PI19/00670
- Acronym
- TeleFall
- Status last verified
- May 2024
- First submitted
- 28 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: MAIN RESULTS
Publications
Cubo E, Garcia-Bustillo A, Arnaiz-Gonzalez A, Ramirez-Sanz JM, Garrido-Labrador JL, Valinas F, Allende M, Gonzalez-Bernal JJ, Gonzalez-Santos J, Diez-Pastor JF, Jahouh M, Arribas J, Trejo J. Adopting a multidisciplinary telemedicine intervention for fall prevention in Parkinson's disease. Protocol for a longitudinal, randomized clinical trial. PLoS One. 2021 Dec 21;16(12):e0260889. doi: 10.1371/journal.pone.0260889. eCollection 2021.
PubMed 34932580
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
- Feasibility and Cost-effectiveness of a Multidisciplinary Home-based Telehealth Intervention Program to Reduce Falls in Parkinson´s Disease (TeleFall).
- ClinicalTrials.gov ID
- NCT04694443
- Acronym / sponsor ID
- TeleFall / PI19/00670
- Conditions
- Parkinson Disease
- Keywords
- Falls, Cost-effectiveness, Qaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Esther CuboUniversity, hospital or other
- Collaborators
- Hospital Universitario de Burgos, Instituto de Salud Carlos III, University of Burgos
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 31 Dec 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.
Falls in Parkinson's Disease (PD) are very frequent with often devastating consequences, increasing comorbidity, mortality, decreased quality of life and increased socio-health costs. In this national, single-center, single-blind, randomized, case-control study, non-demented patients with idiopathic PD with high risk of falling will be included. The main objective of this study is to determine the cost-effectiveness of a home-based, multidisciplinary tele-health intervention to decrease the risk of falling.
Detailed description
In this study, PD patients using multidisciplinary tele-health intervention (study group) will be compared to age, gender-matched PD patients receiving the best standard in-office clinical management (control group). Both groups will be followed for 8 months.
The main outcome will be the comparison of incidence of falls between the study and control groups. Secondary outcomes will include the analysis of cost-effectiveness of multidisciplinary tele-health interventions.
The results of this study will allow us to study the feasibility of remote health care to prevent falls in patients with PD, allowing equity in the distribution and access to specialized health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind, randomized, case-control study
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)The study group will receive the multidisciplinary tele-health intervention plus standard medical care |
| Control group | Placebo comparator | Other: Standard in-office medical careThe control group will receive the best standard medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-demented patients
- Patients diagnosed with idiopathic Parkinson´s disease
- Patients able to walk with a Hoehn Yahr stage < 3
Key exclusion criteria (2 listed)
- Non-ambulatory patients with Parkinson´s disease
- Patients diagnosed with significant comorbidity (psychiatric, systemic, hearing or visual disturbances) according to the investigator criteria.
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 |
|---|---|---|
| Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)Also: EducationNon-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits | Procedure or surgery | Study group |
| Standard in-office medical careNon-pharmacological and pharmacological treatment provided in-office visits | Other | Control group |
Primary outcome
Incidence of falls reduction
Time frame: 8 months
Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors
Feasibility
Time frame: 8 months
Number of virtual videoconferences completed
2 secondary outcomes
Cost-effectiveness
Time frame: 8 months
Healt-related quality of life
Time frame: 8 months
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.
- Derived from this study: PubMed 34932580Cubo E, Garcia-Bustillo A, Arnaiz-Gonzalez A, Ramirez-Sanz JM, Garrido-Labrador JL, Valinas F, Allende M, Gonzalez-Bernal JJ, Gonzalez-Santos J, Diez-Pastor JF, Jahouh M, Arribas J, Trejo J. Adopting a multidisciplinary telemedicine intervention for fall prevention in Parkinson's disease. Protocol for a longitudinal, randomized clinical trial. PLoS One. 2021 Dec 21;16(12):e0260889. doi: 10.1371/journal.pone.0260889. eCollection 2021.
- Individual participant dataSharing planned: No. MAIN RESULTS
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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 Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist) and Standard in-office medical care in people with Parkinson Disease, run by Esther Cubo 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 3 inclusion and 2 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. Some participants in this study may receive a placebo. 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?
Incidence of falls reduction (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694443, which also lists 1 linked publication.
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.