<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/NCT03300219</url>
  </required_header>
  <id_info>
    <org_study_id>HerzogH</org_study_id>
    <nct_id>NCT03300219</nct_id>
  </id_info>
  <brief_title>Tele-rehabilitation Intervention for People Post Hip Fracture - Pilot Study</brief_title>
  <official_title>Effectiveness of a Tele-rehabilitation Intervention to Improve Performance and Reduce Morbidity for People Post Hip Fracture - Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herzog Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hebrew University of Jerusalem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Israel National Institute for Health Policy and Health Services Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Herzog Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Most surviving hip-fracture patients experience reduced mobility and lose their functional&#xD;
      ability, which increases the risk of complications and rehospitalization. Post-discharge&#xD;
      transitional programs to reduce readmissions have shown some success. Telerehabilitation&#xD;
      refers to the use of technologies to provide rehabilitation services to people in their&#xD;
      homes. Considering the need for long-term follow-up care for people with hip fracture,&#xD;
      in-home telerehabilitation could increase independence, decrease hospital stays and reduce&#xD;
      the burden for caregivers.&#xD;
&#xD;
      The purpose of the pilot study is to examine the feasibility and acceptability of the&#xD;
      research methods evaluating telerehabilitation with adults who have experienced hip fracture,&#xD;
      in preparation for a larger randomized controlled study. A one-group (N=6) pre-test/post-test&#xD;
      design is currently being constructed. Results of the pilot study will be used to determine&#xD;
      what adaptations to the design may be required to ensure successful implementation.&#xD;
      Recruitment, retention and attendance rates, as well as percentages completing the outcome&#xD;
      measures, will be examined to plan the time frame of the main trial.&#xD;
&#xD;
      The intervention will include 10 videoconferencing sessions from an occupational therapist in&#xD;
      the presence of the primary caregiver. Each session will be utilized to guide the&#xD;
      participants to achieve their self-identified goals, focusing on problem-solving for daily&#xD;
      life situations and on the ability to implement the discussed strategies for a variety of&#xD;
      activities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline at post intervention in The Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months</time_frame>
    <description>The COPM will be used for measuring performance and satisfaction with personally identified participation goals. Participants are asked to identify goals and then rate their performance and satisfaction with current status on a scale from 1 to 10, where 10 indicates optimal performance or satisfaction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM)</measure>
    <time_frame>Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months</time_frame>
    <description>The aim of the FIM is to monitor the recovery of functional ability by people undergoing rehabilitation. The FIM is comprised of 18 parameters, each rated on a scale of 1-7 (range = 18-126) according to the degree of assistance required to perform a specific activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Geriatric Depression Scale (GDS)</measure>
    <time_frame>Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months</time_frame>
    <description>The scale consists of 15 items; each item has two possible answers (yes or no). The highest possible score is 15, which indicates the most severe depressive state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-item MOS Short-Form Health Status Survey, Hebrew version</measure>
    <time_frame>Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months</time_frame>
    <description>This generic HR-QoL instrument focuses on functional status. The questionnaire includes 12 items taken directly from the SF-36[73] which are used to calculate the Physical and Mental Component Summary. The first question measured by the SF-12 is an acceptable self-rated measure for general health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Zarit Caregiver Burden Interview</measure>
    <time_frame>Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months</time_frame>
    <description>The ZBI includes 22 statements recorded in a 0-4 Likert scale (total score range 0 to 88, where higher scores mean higher burden), which rates the subjective component of burden</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative interview</measure>
    <time_frame>post intervention, 10 weeks (T1)</time_frame>
    <description>Semi-structured interviews will be conducted post intervention with the patients and their caregivers to identify barriers and facilitators regarding the intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">6</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>telerehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. The intervention will be performed by real-time video-conferencing using an iPad® and Skype™, a software program that allows video calls over the Internet</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Orientation to Occupational Performance</intervention_name>
    <description>CO-OP is a top-down, task-oriented, client-centered approach that uses an iterative process of dynamic performance analysis and guided discovery to enable individuals to identify strategies that will improve performance</description>
    <arm_group_label>telerehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older adults (age ≥60 years)&#xD;
&#xD;
          -  post hip fracture - discharged from the inpatient rehabilitation unit of Herzog&#xD;
             Hospital, Jerusalem, between January 2017 and December 2017.&#xD;
&#xD;
          -  Discharge from rehabilitation to a non-institutionalized setting.&#xD;
&#xD;
          -  broadband or Wi-Fi in their home and must be able to operate an iPad independently.&#xD;
&#xD;
          -  FIM&gt;90 at discharge.&#xD;
&#xD;
          -  Has a designated caregiver (a close friend, family member, or support worker) aged&#xD;
             over 18, and a Hebrew, English or Arabic speaker, who will agree to cooperate in the&#xD;
             research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aphasia.&#xD;
&#xD;
          -  cognitive impairment (Montreal Cognitive Assessment scores : MOCA&lt;19 or MMSE&lt;21).&#xD;
&#xD;
          -  degenerative neurological diagnoses.&#xD;
&#xD;
          -  current major depressive or psychotic disorder.&#xD;
&#xD;
          -  other acute or chronic health condition that will influence their ability to&#xD;
             participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yafit Gilboa, OTphD</last_name>
    <role>Study Director</role>
    <affiliation>School of Occupational Therapy, Faculty of Medicine Hadassah and the Hebrew University of Jerusalem</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yafit Gilboa, OTphD</last_name>
    <phone>+972523362230</phone>
    <email>yafitgilboa@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Talia Maeir, BOT</last_name>
    <phone>+972547866338</phone>
    <email>taliabengigi@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Herzog Hospital</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yakir Kaufmam, MD</last_name>
      <phone>+972545703130</phone>
      <email>ykaufman@herzoghospital.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herzog Hospital</investigator_affiliation>
    <investigator_full_name>Yakir Kaufman</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>telerehabilitation</keyword>
  <keyword>occupational therapy</keyword>
  <keyword>rct</keyword>
  <keyword>participation</keyword>
  <keyword>quality of life</keyword>
  <keyword>intervention</keyword>
  <keyword>older adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03300219
org study id: HerzogH
nct id: NCT03300219
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Most surviving hip-fracture patients experience reduced mobility and lose their functional
      ability, which increases the risk of complications and rehospitalization. Post-discharge
      transitional programs to reduce readmissions have shown some success. Telerehabilitation
      refers to the use of technologies to provide rehabilitation services to people in their
      homes. Considering the need for long-term follow-up care for people with hip fracture,
      in-home telerehabilitation could increase independence, decrease hospital stays and reduce
      the burden for caregivers.

      The purpose of the pilot study is to examine the feasibility and acceptability of the
      research methods evaluating telerehabilitation with adults who have experienced hip fracture,
      in preparation for a larger randomized controlled study. A one-group (N=6) pre-test/post-test
      design is currently being constructed. Results of the pilot study will be used to determine
      what adaptations to the design may be required to ensure successful implementation.
      Recruitment, retention and attendance rates, as well as percentages completing the outcome
      measures, will be examined to plan the time frame of the main trial.

      The intervention will include 10 videoconferencing sessions from an occupational therapist in
      the presence of the primary caregiver. Each session will be utilized to guide the
      participants to achieve their self-identified goals, focusing on problem-solving for daily
      life situations and on the ability to implement the discussed strategies for a variety of
      activities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline at post intervention in The Canadian Occupational Performance Measure (COPM)
time frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
description: The COPM will be used for measuring performance and satisfaction with personally identified participation goals. Participants are asked to identify goals and then rate their performance and satisfaction with current status on a scale from 1 to 10, where 10 indicates optimal performance or satisfaction
measure: Functional Independence Measure (FIM)
time frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
description: The aim of the FIM is to monitor the recovery of functional ability by people undergoing rehabilitation. The FIM is comprised of 18 parameters, each rated on a scale of 1-7 (range = 18-126) according to the degree of assistance required to perform a specific activity
measure: The Geriatric Depression Scale (GDS)
time frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
description: The scale consists of 15 items; each item has two possible answers (yes or no). The highest possible score is 15, which indicates the most severe depressive state.
measure: 12-item MOS Short-Form Health Status Survey, Hebrew version
time frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
description: This generic HR-QoL instrument focuses on functional status. The questionnaire includes 12 items taken directly from the SF-36[73] which are used to calculate the Physical and Mental Component Summary. The first question measured by the SF-12 is an acceptable self-rated measure for general health
measure: The Zarit Caregiver Burden Interview
time frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
description: The ZBI includes 22 statements recorded in a 0-4 Likert scale (total score range 0 to 88, where higher scores mean higher burden), which rates the subjective component of burden
measure: Qualitative interview
time frame: post intervention, 10 weeks (T1)
description: Semi-structured interviews will be conducted post intervention with the patients and their caregivers to identify barriers and facilitators regarding the intervention
arm group label: telerehabilitation
arm group type: Experimental
description: Telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. The intervention will be performed by real-time video-conferencing using an iPad® and Skype™, a software program that allows video calls over the Internet
intervention type: Behavioral
intervention name: Cognitive Orientation to Occupational Performance
description: CO-OP is a top-down, task-oriented, client-centered approach that uses an iterative process of dynamic performance analysis and guided discovery to enable individuals to identify strategies that will improve performance
arm group label: telerehabilitation
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yafit Gilboa, OTphD
role: Study Director
affiliation: School of Occupational Therapy, Faculty of Medicine Hadassah and the Hebrew University of Jerusalem
last name: Yafit Gilboa, OTphD
phone: +972523362230
email: yafitgilboa@yahoo.com
last name: Talia Maeir, BOT
phone: +972547866338
email: taliabengigi@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Herzog Hospital
investigator full name: Yakir Kaufman
investigator title: MD
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: No