Multidisciplinary Home-based Tele-rehabilitation Intervention

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Procedure: Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist); Other: Standard in-office medical care

• Registration Number: NCT04694443
• Lead Sponsor: Esther Cubo

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2021-01-03
• Study First Posted: 2021-01-05
• Primary Completion: 2022-10-30
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)	The study group will receive the multidisciplinary tele-health intervention plus standard medical care
Control group	Standard in-office medical care	The control group will receive the best standard medical care

Primary Outcome Measures

Name	Time	Method
Incidence of falls reduction	8 months	Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors
Feasibility	8 months	Number of virtual videoconferences completed

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	8 months	To compare the medical and non-medical direct costs between the study and control groups by using structured questionnaires
Healt-related quality of life	8 months	To compare the PDQ-39 scores between the study and control groups

Trial Locations

Locations (1)

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain