Strategies for Preventing Falls in the Elderly

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
To compare the effects of two different strategies for preventing falls through telerehabilitation for elderly fallers after admission to an emergency room.

Official Title
-----------------
Effects of Two Strategies for Preventing Falls in the Elderly Through Telerehabilitation: A Randomized Clinical Trial

Conditions
-----------------
Fall, Elderly, Prevention, Telehealth, Physical Therapy

Intervention / Treatment
-----------------
* Other: real-time intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elderly fallers Exclusion Criteria: neurological diseases

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive services<br>Otago exercises performed in real-time or synchronous mode of digital health care. It consists of direct communication between physiotherapist and the patient. | Other: real-time intervention<br>* An individual exercise program will be carried out at home, supervised remotely via videoconference.<br>|
| Active Comparator: Remote telemonitoring<br>Otago exercises performed remotely, using technologies such as messaging apps. It consists of indirect communication between physiotherapist and the patient. | Other: real-time intervention<br>* An individual exercise program will be carried out at home, supervised remotely via videoconference.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Falls | 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 | The assessment will consist of Self-efficacy tests for Falls | through study completion, an average of 1 year | 
| Balance | The assessment will consist of Timed-Up and Go test | through study completion, an average of 1 year | 
| Arms Muscle strength | Palm Grip Strength | through study completion, an average of 1 year | 
| Legs Muscle strength | Sitting and Rising from a Chair tests | through study completion, an average of 1 year | 
| Functionality | Katz Index on elderly functionality evaluation for the analysis of basic activities | through study completion, an average of 1 year |