Multidisciplinary Home-based Tele-rehabilitation Intervention

Parkinson Disease Clinical Trial

— TeleFall  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694443
• Other study ID #: PI19/00670
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Hospital Universitario de Burgos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)
Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits

Other:
• Standard in-office medical care
Non-pharmacological and pharmacological treatment provided in-office visits

Locations

Country	Name	City	State
Spain	Hospital Universitario de Burgos	Burgos

Sponsors (4)

Lead Sponsor	Collaborator
Esther Cubo	Hospital Universitario de Burgos, Instituto de Salud Carlos III, University of Burgos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of falls reduction	Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors	8 months
Primary	Feasibility	Number of virtual videoconferences completed	8 months
Secondary	Cost-effectiveness	To compare the medical and non-medical direct costs between the study and control groups by using structured questionnaires	8 months
Secondary	Healt-related quality of life	To compare the PDQ-39 scores between the study and control groups	8 months