Clinical trial NCT02968589: @ctiveHip Tele-rehabilitation System
Official title: @ctiveHip: Tele-rehabilitation System for Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Keywords: Tele-rehabilitation
Function
Quality of life
Exercise
Occupational Therapy
Physiotherapy
Caregiver burden
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Universitario de Granada
name: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
First posted: 2016-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Level
timeFrame: Participants will be followed over 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 12 weeks
measure: Mobility
timeFrame: 12 weeks
measure: Physical Function
timeFrame: 12 weeks
measure: Fitness
timeFrame: 12 weeks
measure: Emotional status
timeFrame: 12 weeks
measure: Health Status
timeFrame: 12 weeks
measure: Cognitive status
timeFrame: 12 weeks
measure: Fear of falling
timeFrame: 12 weeks
measure: Pain
timeFrame: 12 weeks
measure: Caregiver burden
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario de Granada
Study officials:
References:
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.
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.
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.