Multidisciplinary Home-based Tele-rehabilitation Intervention (TeleFall)
May 14, 2024 updated by: Esther Cubo
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Burgos, Spain, 09006
- Hospital Universitario de Burgos
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Non-demented patients
- Patients diagnosed with idiopathic Parkinson´s disease
- Patients able to walk with a Hoehn Yahr stage < 3
Exclusion Criteria:
- Non-ambulatory patients with Parkinson´s disease
- Patients diagnosed with significant comorbidity (psychiatric, systemic, hearing or visual disturbances) according to the investigator criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Study group
The study group will receive the multidisciplinary tele-health intervention plus standard medical care
|
Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits
Other Names:
|
|
Placebo Comparator: Control group
The control group will receive the best standard medical care
|
Non-pharmacological and pharmacological treatment provided in-office visits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
8 months
|
|
Feasibility
Time Frame: 8 months
|
Number of virtual videoconferences completed
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost-effectiveness
Time Frame: 8 months
|
To compare the medical and non-medical direct costs between the study and control groups by using structured questionnaires
|
8 months
|
|
Healt-related quality of life
Time Frame: 8 months
|
To compare the PDQ-39 scores between the study and control groups
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
October 30, 2022
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
December 28, 2020
First Submitted That Met QC Criteria
January 3, 2021
First Posted (Actual)
January 5, 2021
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI19/00670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
MAIN RESULTS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.