Multidisciplinary Home-based Tele-rehabilitation Intervention (TeleFall)

May 14, 2024 updated by: Esther Cubo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esther Cubo

Collaborators

Instituto de Salud Carlos III
Hospital Universitario de Burgos
University of Burgos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 28, 2020

First Submitted That Met QC Criteria

January 3, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI19/00670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

MAIN RESULTS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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