- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06089213
Strategies for Preventing Falls in the Elderly (Telehealth)
October 16, 2023 updated by: Éder Kröeff Cardoso, Federal University of Health Science of Porto Alegre
Effects of Two Strategies for Preventing Falls in the Elderly Through Telerehabilitation: A Randomized Clinical Trial
Fall incidents are the third cause of chronic disability in the elderly, according to the World Health Organization (WHO).
Recent reviews demonstrate that multifactorial and multicomponent intervention programs are effective in preventing falls in community-dwelling older adults.
However, the application of these programs may not be accessible to a large part of the elderly population.
The lack of continuity in the treatment of the consequences of falls, as well as the dissemination of prevention measures for this patient profile, could be minimized through the use of information and communication technologies.
Method: This will be a randomized clinical trial that aims to evaluate the effects of two fall prevention strategies via telerehabilitation for elderly fallers after admission to an emergency room.
It will be carried out by a multidisciplinary team with interventions for eight weeks and monitoring of outcomes over a period of four months.
Patients will be evaluated regarding aspects of functionality in the second and month after the interventions and regarding the recurrence of falls during the four-month period.
Discussion: The hypothesis is that the programs are viable in terms of accessibility to home training.
However, to date, there is no evidence about the differences between these forms of interventions to prevent falls via telecare.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To compare the effects of two different strategies for preventing falls through telerehabilitation for elderly fallers after admission to an emergency room.
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
RS
-
Porto Alegre, RS, Brazil, 90880-370
- Hospital de Pronto Socorro
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- elderly fallers
Exclusion Criteria:
- neurological diseases
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interactive services
Otago exercises performed in "real-time" or "synchronous" mode of digital health care.
It consists of direct communication between physiotherapist and the patient.
|
An individual exercise program will be carried out at home, supervised remotely via videoconference.
|
|
Active Comparator: Remote telemonitoring
Otago exercises performed remotely, using technologies such as messaging apps.
It consists of indirect communication between physiotherapist and the patient.
|
An individual exercise program will be carried out at home, supervised remotely via videoconference.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Falls
Time Frame: four months
|
After the intervention periods, participants will be followed for another 16 weeks.
Every week, recurrences of falls will be recorded via telephone calls.
You will be asked whether there were falls in the period
|
four months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concern of falls
Time Frame: through study completion, an average of 1 year
|
The assessment will consist of Self-efficacy tests for Falls
|
through study completion, an average of 1 year
|
|
Balance
Time Frame: through study completion, an average of 1 year
|
The assessment will consist of Timed-Up and Go test
|
through study completion, an average of 1 year
|
|
Arms Muscle strength
Time Frame: through study completion, an average of 1 year
|
Palm Grip Strength
|
through study completion, an average of 1 year
|
|
Legs Muscle strength
Time Frame: through study completion, an average of 1 year
|
Sitting and Rising from a Chair tests
|
through study completion, an average of 1 year
|
|
Functionality
Time Frame: through study completion, an average of 1 year
|
Katz Index on elderly functionality evaluation for the analysis of basic activities
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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, 2021
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 2, 2023
Study Registration Dates
First Submitted
September 26, 2023
First Submitted That Met QC Criteria
October 16, 2023
First Posted (Actual)
October 18, 2023
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 16, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- HPSPoA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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