Multidisciplinary Home-based Tele-rehabilitation Intervention (TeleFall)

Esther Cubo

Status: Completed

Conditions: Parkinson Disease

Treatments: Procedure: Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist); Other: Standard in-office medical care

Study type: Interventional

Funder types: Other

Identifiers

NCT04694443

PI19/00670

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Study group

Active Comparator group

Description:

The study group will receive the multidisciplinary tele-health intervention plus standard medical care

Treatment:

Procedure: Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)

Control group

Placebo Comparator group

Description:

The control group will receive the best standard medical care

Treatment:

Other: Standard in-office medical care