<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02968589</url>
  </required_header>
  <id_info>
    <org_study_id>University Hospital of Granada</org_study_id>
    <nct_id>NCT02968589</nct_id>
  </id_info>
  <brief_title>@ctiveHip Tele-rehabilitation System</brief_title>
  <acronym>@ctiveHip</acronym>
  <official_title>@ctiveHip: Tele-rehabilitation System for Hip Fracture Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Complejo Hospitalario Universitario de Granada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Granada</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the @ctivehip tele-rehabilitation system&#xD;
      improves the functional level and quality of life of hip fracture patients and reduce the&#xD;
      caregiver burden.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The best option for rehabilitation after a hip fracture is still unclear. The&#xD;
      home rehabilitation is one of the options and the use of tele-rehabilitation programs at home&#xD;
      could be the option for some patients in the future. The main objective of this study is to&#xD;
      improve the functional level and quality of life of hip fracture patients and reduce the&#xD;
      caregiver burden using the @ctivehip tele-rehabilitation system.&#xD;
&#xD;
      Methods: This project will include hip fracture patients who met the following inclusion&#xD;
      criteria: having a high pre-fracture functional level, not having severe cognitive&#xD;
      impairment, absence of terminal disease, absence of post-surgery complications, going to live&#xD;
      to their home or a relative home at hospital discharge, and signing an informed consent. The&#xD;
      criteria to be part of this experimental group will be: having internet at home and a main&#xD;
      caregiver with the ability to use the internet (@ctiveHip system). Patients without the&#xD;
      internet at home will be part of the no intervention group, and they will receive the usual&#xD;
      care, in addition to a triptych with information on recommendations and exercises to do at&#xD;
      home. Caregivers of patients of both groups will receive a training session on patient&#xD;
      management. Patients will be assessed at 4-weeks and 12 weeks after beginning to use the&#xD;
      @ctiveHip system. The primary outcome will be the Functional level, measured by the&#xD;
      Functional Independence Measure. The secondary outcomes: quality of life (Euro-qol), physical&#xD;
      function (Timed Up and Go, Short Physical Performance Battery, International Fitness Scale),&#xD;
      emotional status ( The Hospital Anxiety and Depression Scale ), health status (American&#xD;
      Society of Anesthesiologists Score), cognitive status (Mini-mental Test ), fear of falling&#xD;
      (Short Falls efficacy scale), pain (visual analogue scale), and caregiver burden of care&#xD;
      (Zarit Burden Interview).&#xD;
&#xD;
      Discussion: This study has been designed to provide a tele-rehabilitation system which&#xD;
      includes a rehabilitation protocol created by a multidisciplinary team of surgeons,&#xD;
      occupational therapist, physiotherapist, and sport scientist, to improve the functional level&#xD;
      of patients after hip fracture surgery. The @ctiveHip system could be a new low cost&#xD;
      treatment option for some hip fracture patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Level</measure>
    <time_frame>Participants will be followed over 12 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility</measure>
    <time_frame>12 weeks</time_frame>
    <description>Timed Up and Go test will be used to measure physical function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Function</measure>
    <time_frame>12 weeks</time_frame>
    <description>Short Physical Performance Battery will be used to measure physical function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fitness</measure>
    <time_frame>12 weeks</time_frame>
    <description>International Fitness Scale will be used to evaluate perceived patient´s overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional status</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Hospital Anxiety and Depression Scale will be used to evaluate the emotional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status</measure>
    <time_frame>12 weeks</time_frame>
    <description>Health Status will be assessed using the American Society of Anesthesiologists Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive status</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mini-mental Test will be used to measure the cognitive status of hip fracture patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of falling</measure>
    <time_frame>12 weeks</time_frame>
    <description>Short Falls Efficacy Scale will be used to assess fear of falling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>12 weeks</time_frame>
    <description>The pain will be assessed using the Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver burden</measure>
    <time_frame>12 weeks</time_frame>
    <description>Zarit Burden Interview will be used to evaluate the caregiver burden of care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>@ctiveHip intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A training session for caregivers of patients with hip fracture on patient management.&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A training session for caregivers of patients with hip fracture on patient management.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training</intervention_name>
    <arm_group_label>@ctiveHip intervention</arm_group_label>
    <arm_group_label>Other training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who had hip fracture surgery&#xD;
&#xD;
        Having a high pre-fracture functional level&#xD;
&#xD;
        Having Internet at home&#xD;
&#xD;
        Hospital discharge to their homes or a relative home.&#xD;
&#xD;
        A main caregiver who has the ability to use the internet (@ctivehip system)&#xD;
&#xD;
        Have signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Presence of severe cognitive impairment&#xD;
&#xD;
        Presence of terminal disease&#xD;
&#xD;
        Presence of post-surgery complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Patrocinio Ariza-Vega, PhD</last_name>
    <phone>0034637205620</phone>
    <email>pariza@ugr.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Granada</name>
      <address>
        <city>Granada</city>
        <zip>18013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrocinio Ariza, PhD</last_name>
      <email>pariza@ugr.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Patrocinio Ariza Vega</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Tele-rehabilitation</keyword>
  <keyword>Function</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Exercise</keyword>
  <keyword>Occupational Therapy</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Caregiver burden</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02968589
org study id: University Hospital of Granada
nct id: NCT02968589
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Functional Level
time frame: Participants will be followed over 12 weeks
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.
measure: Quality of life
time frame: 12 weeks
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.
measure: Mobility
time frame: 12 weeks
description: Timed Up and Go test will be used to measure physical function.
measure: Physical Function
time frame: 12 weeks
description: Short Physical Performance Battery will be used to measure physical function.
measure: Fitness
time frame: 12 weeks
description: International Fitness Scale will be used to evaluate perceived patient´s overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility.
measure: Emotional status
time frame: 12 weeks
description: The Hospital Anxiety and Depression Scale will be used to evaluate the emotional status
measure: Health Status
time frame: 12 weeks
description: Health Status will be assessed using the American Society of Anesthesiologists Score
measure: Cognitive status
time frame: 12 weeks
description: Mini-mental Test will be used to measure the cognitive status of hip fracture patients.
measure: Fear of falling
time frame: 12 weeks
description: Short Falls Efficacy Scale will be used to assess fear of falling
measure: Pain
time frame: 12 weeks
description: The pain will be assessed using the Visual Analogue Scale
measure: Caregiver burden
time frame: 12 weeks
description: Zarit Burden Interview will be used to evaluate the caregiver burden of care
arm group label: @ctiveHip intervention
arm group type: Experimental
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 group label: Other training
arm group type: Active Comparator
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: Training
arm group label: @ctiveHip intervention
arm group label: Other training
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Patrocinio Ariza-Vega, PhD
phone: 0034637205620
email: pariza@ugr.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Patrocinio Ariza Vega
investigator title: PhD
mesh term: Hip Fractures