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Hip Fractures@ctiveHipNCT02968589

@ctiveHip Tele-rehabilitation System

A study testing Training in people with Hip Fractures, run by Universidad de Granada at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hip Fractures
What is being tested?
Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
Jan 2017to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Presence of severe cognitive impairment
  • Presence of terminal disease
  • Presence of post-surgery complications

Trial locations and contacts

1 site in 1 country.

Patrocinio Ariza-Vega, PhD contact

0034637205620

pariza@ugr.es

Spain1 site, 1 recruiting

  • Complejo Hospitalario Universitario de Granada

    Granada, 18013

    Patrocinio Ariza, PhD, pariza@ugr.es

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
Hip Fractures
Being tested
Training
Keywords
Tele-rehabilitation, Function, Quality of life, Exercise, Occupational Therapy, Physiotherapy, Caregiver burden
Medical subject headings
Hip Fractures, Motor Activity, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrainingBehavioural

Study groups in NCT02968589
Study groupRoleWhat they receive
@ctiveHip interventionExperimentalA 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.
Receives: Behavioral: Training
Other trainingActive comparatorA 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.
Receives: Behavioral: Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Participants will be followed over 12 weeks

Secondary outcomes (10)

  1. 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.

    Measured: 12 weeks

  2. Mobility

    Timed Up and Go test will be used to measure physical function.

    Measured: 12 weeks

  3. Physical Function

    Short Physical Performance Battery will be used to measure physical function.

    Measured: 12 weeks

  4. Fitness

    International Fitness Scale will be used to evaluate perceived patient´s overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility.

    Measured: 12 weeks

  5. Emotional status

    The Hospital Anxiety and Depression Scale will be used to evaluate the emotional status

    Measured: 12 weeks

  6. Health Status

    Health Status will be assessed using the American Society of Anesthesiologists Score

    Measured: 12 weeks

  7. Cognitive status

    Mini-mental Test will be used to measure the cognitive status of hip fracture patients.

    Measured: 12 weeks

  8. Fear of falling

    Short Falls Efficacy Scale will be used to assess fear of falling

    Measured: 12 weeks

  9. Pain

    The pain will be assessed using the Visual Analogue Scale

    Measured: 12 weeks

  10. Caregiver burden

    Zarit Burden Interview will be used to evaluate the caregiver burden of care

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02968589
Sponsor's protocol ID
University Hospital of Granada
Acronym
@ctiveHip
Status last verified
Apr 2018
First submitted
13 Nov 2016
Last updated
5 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Prieto-Moreno R, Molina-Garcia P, Ortiz-Pina M, Mora-Traverso M, Estevez-Lopez F, Martin-Matillas M, Ariza-Vega P. Association of the @ctivehip tele-rehabilitation with the fear of falling of older adults with hip fracture and their family caregivers: Secondary analysis of a non-randomised controlled trial. J Telemed Telecare. 2025 Sep;31(8):1152-1161. doi: 10.1177/1357633X241257972. Epub 2024 Jun 5.

    PubMed 38836335

  • Mora-Traverso M, Prieto-Moreno R, Molina-Garcia P, Salas-Farina Z, Martin-Martin L, Martin-Matillas M, Ariza-Vega P. Effects of the @ctivehip telerehabilitation program on the quality of life, psychological factors and fitness level of patients with hip fracture. J Telemed Telecare. 2024 Apr;30(3):549-558. doi: 10.1177/1357633X211073256. Epub 2022 Jan 21.

    PubMed 35060784

  • 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.

    PubMed 34945145

  • 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.

    PubMed 34065523

  • 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.

    PubMed 30444530

Questions about this trial

What is this clinical trial studying?

A study testing Training in people with Hip Fractures, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrocinio Ariza-Vega, PhD (0034637205620, pariza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Level (time frame: Participants will be followed over 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02968589, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.

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