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Completed

NCT Number: NCT04694443

Multidisciplinary Home-based Tele-rehabilitation Intervention

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Burgos

Burgos, 09006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits

Other names: Education

Standard in-office medical care

Other

Non-pharmacological and pharmacological treatment provided in-office visits

Primary outcomes

  1. 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

  2. Feasibility

    Time frame: 8 months

    Number of virtual videoconferences completed

Secondary outcomes

  1. 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

  2. Healt-related quality of life

    Time frame: 8 months

    To compare the PDQ-39 scores between the study and control groups

Sponsors and collaborators

Lead sponsor

Esther Cubo

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TeleFall

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 5, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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