@ctiveHip Tele-rehabilitation System

Study Overview
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Brief Summary
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The purpose of this study is to determine if the @ctivehip tele-rehabilitation system improves the functional level and quality of life of hip fracture patients and reduce the caregiver burden.

Detailed Description
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Background: The best option for rehabilitation after a hip fracture is still unclear. The home rehabilitation is one of the options and the use of tele-rehabilitation programs at home could be the option for some patients in the future. The main objective of this study is to improve the functional level and quality of life of hip fracture patients and reduce the caregiver burden using the @ctivehip tele-rehabilitation system. Methods: This project will include hip fracture patients who met the following inclusion criteria: having a high pre-fracture functional level, not having severe cognitive impairment, absence of terminal disease, absence of post-surgery complications, going to live to their home or a relative home at hospital discharge, and signing an informed consent. The criteria to be part of this experimental group will be: having internet at home and a main caregiver with the ability to use the internet (@ctiveHip system). Patients without the internet at home will be part of the no intervention group, and they will receive the usual care, in addition to a triptych with information on recommendations and exercises to do at home. Caregivers of patients of both groups will receive a training session on patient management. Patients will be assessed at 4-weeks and 12 weeks after beginning to use the @ctiveHip system. The primary outcome will be the Functional level, measured by the Functional Independence Measure. The secondary outcomes: quality of life (Euro-qol), physical function (Timed Up and Go, Short Physical Performance Battery, International Fitness Scale), emotional status ( The Hospital Anxiety and Depression Scale ), health status (American Society of Anesthesiologists Score), cognitive status (Mini-mental Test ), fear of falling (Short Falls efficacy scale), pain (visual analogue scale), and caregiver burden of care (Zarit Burden Interview). Discussion: This study has been designed to provide a tele-rehabilitation system which includes a rehabilitation protocol created by a multidisciplinary team of surgeons, occupational therapist, physiotherapist, and sport scientist, to improve the functional level of patients after hip fracture surgery. The @ctiveHip system could be a new low cost treatment option for some hip fracture patients.

Official Title
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@ctiveHip: Tele-rehabilitation System for Hip Fracture Patients

Conditions
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Hip Fractures

Intervention / Treatment
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* Behavioral: Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had hip fracture surgery Having a high pre-fracture functional level Having Internet at home Hospital discharge to their homes or a relative home. A main caregiver who has the ability to use the internet (@ctivehip system) Have signed an informed consent Exclusion Criteria: Presence of severe cognitive impairment Presence of terminal disease Presence of post-surgery complications

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: @ctiveHip intervention<br>A training session for caregivers of patients with hip fracture on patient management. The @ctiveHip tele-rehabilitation system. This system includes a 3-months occupational therapy and exercise-based program, recommendations for patients and their caregivers and the option of chats and videoconferences. The program consists of 5 sessions/week of 50-60 minutes that patients will do at home. Each session includes videos with the prescribed activities and exercises that the patients will find in the private site of www.activehip.es. | Behavioral: Training<br> <br> |
| Active Comparator: Other training<br>A training session for caregivers of patients with hip fracture on patient management. The usual care for hip fracture patients at hospital discharge. In addition, patients and their families will receive a triptych with information on recommendations and exercises to do at home. | Behavioral: Training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Level | The primary outcome will be assessed with the Functional Independence Measure, which is one of the most widely used instruments to measure Functional Level of hip fracture patients. | Participants will be followed over 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | The secondary outcome will be assessed with the EuroQoL Quality of Life Questionnaire which is one of the most widely used instruments to measure quality of life of hip fracture patients. | 12 weeks | 
| Mobility | Timed Up and Go test will be used to measure physical function. | 12 weeks | 
| Physical Function | Short Physical Performance Battery will be used to measure physical function. | 12 weeks | 
| Fitness | International Fitness Scale will be used to evaluate perceived patient´s overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility. | 12 weeks | 
| Emotional status | The Hospital Anxiety and Depression Scale will be used to evaluate the emotional status | 12 weeks | 
| Health Status | Health Status will be assessed using the American Society of Anesthesiologists Score | 12 weeks | 
| Cognitive status | Mini-mental Test will be used to measure the cognitive status of hip fracture patients. | 12 weeks | 
| Fear of falling | Short Falls Efficacy Scale will be used to assess fear of falling | 12 weeks | 
| Pain | The pain will be assessed using the Visual Analogue Scale | 12 weeks | 
| Caregiver burden | Zarit Burden Interview will be used to evaluate the caregiver burden of care | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tele-rehabilitation, Function, Quality of life, Exercise, Occupational Therapy, Physiotherapy, Caregiver burden