NCT04694443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2.8 years

First QC Date

December 28, 2020

Last Update Submit

May 14, 2024

Conditions

Parkinson Disease

Keywords

FallsCost-effectivenessQaly

Outcome Measures

Primary Outcomes (2)

  • Incidence of falls reduction

    Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors

    8 months

  • Feasibility

    Number of virtual videoconferences completed

    8 months

Secondary Outcomes (2)

  • Cost-effectiveness

    8 months

  • Healt-related quality of life

    8 months

Study Arms (2)

Study group

ACTIVE COMPARATOR

The study group will receive the multidisciplinary tele-health intervention plus standard medical care

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

Control group

PLACEBO COMPARATOR

The control group will receive the best standard medical care

Other: Standard in-office medical care

Interventions

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

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

Also known as: Education
Study group
Standard in-office medical careOTHER

Non-pharmacological and pharmacological treatment provided in-office visits

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-demented patients
  • Patients diagnosed with idiopathic Parkinson´s disease
  • Patients able to walk with a Hoehn Yahr stage \< 3

You may not qualify if:

  • Non-ambulatory patients with Parkinson´s disease
  • Patients diagnosed with significant comorbidity (psychiatric, systemic, hearing or visual disturbances) according to the investigator criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Related Publications (1)

  • 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.

    PMID: 34932580DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy ModalitiesNeurologistsNursesEducational Status

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationPhysiciansHealth PersonnelHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The rater will be blind to the patient status (study vs. control).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single blind, randomized, case-control study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 5, 2021

Study Start

January 1, 2020

Primary Completion

October 30, 2022

Study Completion

December 31, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

MAIN RESULTS

Locations

ES(1)