NCT02968589

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

November 13, 2016

Last Update Submit

April 3, 2018

Conditions

Keywords

Tele-rehabilitationFunctionQuality of lifeExerciseOccupational TherapyPhysiotherapyCaregiver burden

Outcome Measures

Primary Outcomes (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.

    Participants will be followed over 12 weeks

Secondary Outcomes (10)

  • Quality of life

    12 weeks

  • Mobility

    12 weeks

  • Physical Function

    12 weeks

  • Fitness

    12 weeks

  • Emotional status

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

@ctiveHip intervention

EXPERIMENTAL

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

Other training

ACTIVE COMPARATOR

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

Interventions

TrainingBEHAVIORAL
@ctiveHip interventionOther training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Granada

Granada, 18013, Spain

RECRUITING

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Hip FracturesMotor ActivityCaregiver Burden

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesBehaviorStress, PsychologicalBehavioral Symptoms

Central Study Contacts

Patrocinio Ariza-Vega, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 13, 2016

First Posted

November 18, 2016

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations