Clinical trial NCT04694443: Multidisciplinary Home-based Tele-rehabilitation Intervention
Official title: Feasibility and Cost-effectiveness of a Multidisciplinary Home-based Telehealth Intervention Program to Reduce Falls in Parkinson´s Disease (TeleFall).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Falls
Cost-effectiveness
Qaly
Lead sponsor: Hospital Universitario de Burgos
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Burgos
name: Instituto de Salud Carlos III
name: University of Burgos
First posted: 2021-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind, randomized, case-control study
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of falls reduction
timeFrame: 8 months
measure: Feasibility
timeFrame: 8 months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 8 months
measure: Healt-related quality of life
timeFrame: 8 months
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
Study officials:
References:
citation: 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.