@ctiveHip Tele-rehabilitation System

Hip Fractures Clinical Trial

— @ctiveHip  

Official title:

@ctiveHip: Tele-rehabilitation System for Hip Fracture Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02968589
• Other study ID #: University Hospital of Granada
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2016
• Last updated: April 3, 2018
• Start date: January 2017
• Est. completion date: July 2018

Study information

• Verified date: April 2018
• Source: Universidad de Granada
• Contact: Patrocinio Ariza-Vega, PhD
• Phone: 0034637205620
• Email: pariza[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures

Intervention

Behavioral:
• Training

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Granada	Granada

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Granada	Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud, Complejo Hospitalario Universitario de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mobility	Timed Up and Go test will be used to measure physical function.	12 weeks
Secondary	Physical Function	Short Physical Performance Battery will be used to measure physical function.	12 weeks
Secondary	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
Secondary	Emotional status	The Hospital Anxiety and Depression Scale will be used to evaluate the emotional status	12 weeks
Secondary	Health Status	Health Status will be assessed using the American Society of Anesthesiologists Score	12 weeks
Secondary	Cognitive status	Mini-mental Test will be used to measure the cognitive status of hip fracture patients.	12 weeks
Secondary	Fear of falling	Short Falls Efficacy Scale will be used to assess fear of falling	12 weeks
Secondary	Pain	The pain will be assessed using the Visual Analogue Scale	12 weeks
Secondary	Caregiver burden	Zarit Burden Interview will be used to evaluate the caregiver burden of care	12 weeks

External Links

•   Link