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Multidisciplinary Home-based Tele-rehabilitation Intervention (TeleFall)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)
Standard in-office medical care
Sponsored by
Esther Cubo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring Falls, Cost-effectiveness, Qaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de BurgosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

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

The control group will receive the best standard medical care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 28, 2020
Last Updated
March 15, 2022
Sponsor
Esther Cubo
Collaborators
Hospital Universitario de Burgos, Instituto de Salud Carlos III, University of Burgos
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1. Study Identification

Unique Protocol Identification Number
NCT04694443
Brief Title
Multidisciplinary Home-based Tele-rehabilitation Intervention
Acronym
TeleFall
Official Title
Feasibility and Cost-effectiveness of a Multidisciplinary Home-based Telehealth Intervention Program to Reduce Falls in Parkinson´s Disease (TeleFall).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Esther Cubo
Collaborators
Hospital Universitario de Burgos, Instituto de Salud Carlos III, University of Burgos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Falls, Cost-effectiveness, Qaly

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind, randomized, case-control study
Masking
Outcomes Assessor
Masking Description
The rater will be blind to the patient status (study vs. control).
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
The study group will receive the multidisciplinary tele-health intervention plus standard medical care
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group will receive the best standard medical care
Intervention Type
Procedure
Intervention Name(s)
Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)
Other Intervention Name(s)
Education
Intervention Description
Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits
Intervention Type
Other
Intervention Name(s)
Standard in-office medical care
Intervention Description
Non-pharmacological and pharmacological treatment provided in-office visits
Primary Outcome Measure Information:
Title
Incidence of falls reduction
Description
Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors
Time Frame
8 months
Title
Feasibility
Description
Number of virtual videoconferences completed
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
To compare the medical and non-medical direct costs between the study and control groups by using structured questionnaires
Time Frame
8 months
Title
Healt-related quality of life
Description
To compare the PDQ-39 scores between the study and control groups
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Cubo, MD, PhD
Phone
+34947256533
Email
mcubo@saludcastillayleon.es
First Name & Middle Initial & Last Name or Official Title & Degree
Alvaro Garcia Bustillo, OT
Phone
+34947256533
Ext
35380
Email
alvarogarbu@gmail.com
Facility Information:
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Cubo, MD
Phone
+34947256533
Ext
35380
Email
mcubo@saludcastillayleon.es
First Name & Middle Initial & Last Name & Degree
Alvaro Garcia Bustillo, OT
Phone
+34947256533
Ext
35380
Email
alvarogarbu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
MAIN RESULTS
Citations:
PubMed Identifier
34932580
Citation
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.
Results Reference
derived

Learn more about this trial

Multidisciplinary Home-based Tele-rehabilitation Intervention

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