Multidisciplinary Home-based Tele-rehabilitation Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Cost-effectiveness of a Multidisciplinary Home-based Telehealth Intervention Program to Reduce Falls in Parkinson´s Disease (TeleFall).

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)
* Other: Standard in-office medical care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blind, randomized, case-control study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>The study group will receive the multidisciplinary tele-health intervention plus standard medical care | Procedure: Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)<br>* Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits<br>* Other names: Education;|
| Placebo Comparator: Control group<br>The control group will receive the best standard medical care | Other: Standard in-office medical care<br>* Non-pharmacological and pharmacological treatment provided in-office visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of falls reduction | Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors | 8 months | 
| Feasibility | Number of virtual videoconferences completed | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | 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 | To compare the PDQ-39 scores between the study and control groups | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, Cost-effectiveness, Qaly