search
Back to results

@ctiveHip Tele-rehabilitation System (@ctiveHip)

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Training
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Tele-rehabilitation, Function, Quality of life, Exercise, Occupational Therapy, Physiotherapy, Caregiver burden

Eligibility Criteria

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

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

Sites / Locations

  • Complejo Hospitalario Universitario de GranadaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

@ctiveHip intervention

Other training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Mobility
Timed Up and Go test will be used to measure physical function.
Physical Function
Short Physical Performance Battery will be used to measure physical function.
Fitness
International Fitness Scale will be used to evaluate perceived patient´s overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility.
Emotional status
The Hospital Anxiety and Depression Scale will be used to evaluate the emotional status
Health Status
Health Status will be assessed using the American Society of Anesthesiologists Score
Cognitive status
Mini-mental Test will be used to measure the cognitive status of hip fracture patients.
Fear of falling
Short Falls Efficacy Scale will be used to assess fear of falling
Pain
The pain will be assessed using the Visual Analogue Scale
Caregiver burden
Zarit Burden Interview will be used to evaluate the caregiver burden of care

Full Information

First Posted
November 13, 2016
Last Updated
April 3, 2018
Sponsor
Universidad de Granada
Collaborators
Complejo Hospitalario Universitario de Granada, Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
search

1. Study Identification

Unique Protocol Identification Number
NCT02968589
Brief Title
@ctiveHip Tele-rehabilitation System
Acronym
@ctiveHip
Official Title
@ctiveHip: Tele-rehabilitation System for Hip Fracture Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
Complejo Hospitalario Universitario de Granada, Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Tele-rehabilitation, Function, Quality of life, Exercise, Occupational Therapy, Physiotherapy, Caregiver burden

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
@ctiveHip intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Other training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training
Primary Outcome Measure Information:
Title
Functional Level
Description
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.
Time Frame
Participants will be followed over 12 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
12 weeks
Title
Mobility
Description
Timed Up and Go test will be used to measure physical function.
Time Frame
12 weeks
Title
Physical Function
Description
Short Physical Performance Battery will be used to measure physical function.
Time Frame
12 weeks
Title
Fitness
Description
International Fitness Scale will be used to evaluate perceived patient´s overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility.
Time Frame
12 weeks
Title
Emotional status
Description
The Hospital Anxiety and Depression Scale will be used to evaluate the emotional status
Time Frame
12 weeks
Title
Health Status
Description
Health Status will be assessed using the American Society of Anesthesiologists Score
Time Frame
12 weeks
Title
Cognitive status
Description
Mini-mental Test will be used to measure the cognitive status of hip fracture patients.
Time Frame
12 weeks
Title
Fear of falling
Description
Short Falls Efficacy Scale will be used to assess fear of falling
Time Frame
12 weeks
Title
Pain
Description
The pain will be assessed using the Visual Analogue Scale
Time Frame
12 weeks
Title
Caregiver burden
Description
Zarit Burden Interview will be used to evaluate the caregiver burden of care
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrocinio Ariza-Vega, PhD
Phone
0034637205620
Email
pariza@ugr.es
Facility Information:
Facility Name
Complejo Hospitalario Universitario de Granada
City
Granada
ZIP/Postal Code
18013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrocinio Ariza, PhD
Email
pariza@ugr.es

12. IPD Sharing Statement

Citations:
PubMed Identifier
34945145
Citation
Ariza-Vega P, Prieto-Moreno R, Castillo-Perez H, Martinez-Ruiz V, Romero-Ayuso D, Ashe MC. Family Caregivers' Experiences with Tele-Rehabilitation for Older Adults with Hip Fracture. J Clin Med. 2021 Dec 13;10(24):5850. doi: 10.3390/jcm10245850.
Results Reference
derived
PubMed Identifier
34065523
Citation
Ortiz-Pina M, Molina-Garcia P, Femia P, Ashe MC, Martin-Martin L, Salazar-Gravan S, Salas-Farina Z, Prieto-Moreno R, Castellote-Caballero Y, Estevez-Lopez F, Ariza-Vega P. Effects of Tele-Rehabilitation Compared with Home-Based in-Person Rehabilitation for Older Adult's Function after Hip Fracture. Int J Environ Res Public Health. 2021 May 20;18(10):5493. doi: 10.3390/ijerph18105493.
Results Reference
derived
PubMed Identifier
30444530
Citation
Ortiz-Pina M, Salas-Farina Z, Mora-Traverso M, Martin-Martin L, Galiano-Castillo N, Garcia-Montes I, Cantarero-Villanueva I, Fernandez-Lao C, Arroyo-Morales M, Mesa-Ruiz A, Castellote-Caballero Y, Salazar-Gravan S, Kronborg L, Martin-Matillas M, Ariza-Vega P. A home-based tele-rehabilitation protocol for patients with hip fracture called @ctivehip. Res Nurs Health. 2019 Feb;42(1):29-38. doi: 10.1002/nur.21922. Epub 2018 Nov 16.
Results Reference
derived

Learn more about this trial

@ctiveHip Tele-rehabilitation System

We'll reach out to this number within 24 hrs