<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/NCT03828240</url>
  </required_header>
  <id_info>
    <org_study_id>HerlevGentofte</org_study_id>
    <nct_id>NCT03828240</nct_id>
  </id_info>
  <brief_title>HIP Fracture REhabilitation Programme for Elderly With Hip Fractures</brief_title>
  <acronym>HIP-REP</acronym>
  <official_title>HIP Fracture REhabilitation Programme for Elderly With Hip Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev and Gentofte Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Municipality of Herlev</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Municipality of Lyngby-Taarbæk</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Municipality of Gentofte</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen University Hospital at Herlev</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jonkoping University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Intersectoral Research Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Metropolitan University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Association of Occupational Therapist</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Regions Development and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Herlev and Gentofte Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objectives: To evaluate the feasibility of a HIP fracture REhabilitation Programme&#xD;
      (HIP-REP).This study will investigate adherence, satisfaction, technical and practical&#xD;
      circumstances regarding implementation and taking this into account when evaluating the&#xD;
      feasibility of the HIP-REP program.&#xD;
&#xD;
      Hypothesis: By testing the feasibility of a HIP-REP for the participants and the usefulness&#xD;
      of the selected measurement tools, the investigators will be able to evaluate and adjust the&#xD;
      HIP-REP before evaluating this in a larger Randomized controlled trial (RCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Little is known about the feasibility and effect of an intersectoral rehabilitation&#xD;
      intervention aiming at reducing the decrease in Activities of Daily Living (ADL) ability for&#xD;
      elderly with hip fractures. Despite positive surgical outcomes, one-quarter dies within a&#xD;
      year after surgery, around eight percent are readmitted to hospital, and just one-third&#xD;
      regain their pre-fracture level of physical functioning and ADL ability. After hip fracture,&#xD;
      the loss of independence, and further decrease in ADL ability often persists beyond three&#xD;
      months after surgery. This increases the risk of social isolation, depression and thus a&#xD;
      decrease in Quality of Life (QoL). Therefore, the investigators want to evaluate whether an&#xD;
      activity-based rehabilitation intervention across sectors is feasible and influences this&#xD;
      fragile group of patients. The investigators hope to increase the ability to safely and&#xD;
      independently perform ADL in elderly with hip fractures, and thereby enhance their&#xD;
      health-related QoL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>
    <intervention_model_description>Activity-based intervention</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Motor and Process Skills</measure>
    <time_frame>Change from baseline at motor and process skills 3 months after baseline testing</time_frame>
    <description>The assessment measures the quality of a person's activity of daily living task performance. An observational assessment that allows for evaluation of change in motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living. The instrument consists of 16 motor and 20 process skill abilities that are rated on a 4-point scale, In all, 36 discrete ratings of motor and process skills are made during observation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life Questionnaire</measure>
    <time_frame>at baseline and 3 months after baseline testing</time_frame>
    <description>A survey collecting information about health related quality of life comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal Rating Scale</measure>
    <time_frame>at baseline and 3 months after baseline testing</time_frame>
    <description>An assessment measuring the intensity of pain. The patient chooses one of those: none, mild, moderate or severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occupational Balance Questionnaire</measure>
    <time_frame>at baseline and 3 months after baseline testing</time_frame>
    <description>An assessment that measures the patients satisfaction with the amount and variation of occupations; . It consists of 13 items measured on six-step ordinal scales. The patient chooses one of those: Disagree, partly disagree, partly agree or agree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with daily occupations</measure>
    <time_frame>at baseline and 3 months after baseline testing</time_frame>
    <description>An instrument measuring satisfaction with everyday occupations addressing four areas of everyday occupations: work and work-related occupations, leisure occupations, domestic occupations and self-care. The patient chooses on a scale from 1 to 7. 1 = Not satisfied to 7 = Very satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulated Ambulation Score</measure>
    <time_frame>at baseline</time_frame>
    <description>The Cumulated Ambulation Score is evaluating patients' basic mobility (getting in and out of bed, sit-to-stand from a chair and walking). Each of the three activities is scored from 0-2, resulting in a daily score of 0-6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New Mobility Score</measure>
    <time_frame>at baseline and 3 months after baseline testing</time_frame>
    <description>The New Mobility Score is a composite score of the patient's ability to perform: indoor walking, outdoor walking and shopping, providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function, resulting in a total score from 0 to 9, with nine indicating a high prefracture functional level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Recovery Score</measure>
    <time_frame>at baseline and 3 months after baseline testing</time_frame>
    <description>Functional Recovery Score assess the level of function with eleven-items comprised of three main components: basic activities of daily living assessed by four items, instrumental activities of daily living assessed by six items, and mobility assessed by one item. Basic activities of daily living comprise 44 percent of the score; instrumental activities of daily living comprise 23 percent, and mobility comprises 33 percent. Complete independence in basic and instrumental activities of daily living and mobility results in a score of 100 percent.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Enhanced rehabilitation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HIP fracture REhabilitation Programme for the elderly with hip fractures</intervention_name>
    <description>Eight-week activity-based intervention for elderly with hip fractures; one intervention during the hospital stay, four interventions at the elderly's municipality.</description>
    <arm_group_label>Enhanced rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 65 years or older&#xD;
&#xD;
          -  Recent proximal hip fracture (S 72.0 Medial femur fracture, S 72.1, Pertrochanteric&#xD;
             femur fracture, S 72.2 Subtrochanteric femur fracture)&#xD;
&#xD;
          -  Living at home prior to hip fracture in Herlev, Gentofte or Lyngby-Taarbæk&#xD;
             municipalities&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Discharged from hospital and receiving or having received rehabilitation in one&#xD;
             municipalities within the last 3 months from onset&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not expected to be discharged to home or rehabilitation centers in the municipality&#xD;
&#xD;
          -  Not able to speak and/or understand Danish&#xD;
&#xD;
          -  Have prior severe physical and /or mental disabilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte</name>
      <address>
        <city>Copenhagen</city>
        <state>Herlev</state>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev and Gentofte Hospital</investigator_affiliation>
    <investigator_full_name>Carsten Bogh Juhl</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03828240
org study id: HerlevGentofte
nct id: NCT03828240
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives: To evaluate the feasibility of a HIP fracture REhabilitation Programme
      (HIP-REP).This study will investigate adherence, satisfaction, technical and practical
      circumstances regarding implementation and taking this into account when evaluating the
      feasibility of the HIP-REP program.

      Hypothesis: By testing the feasibility of a HIP-REP for the participants and the usefulness
      of the selected measurement tools, the investigators will be able to evaluate and adjust the
      HIP-REP before evaluating this in a larger Randomized controlled trial (RCT).
Little is known about the feasibility and effect of an intersectoral rehabilitation
      intervention aiming at reducing the decrease in Activities of Daily Living (ADL) ability for
      elderly with hip fractures. Despite positive surgical outcomes, one-quarter dies within a
      year after surgery, around eight percent are readmitted to hospital, and just one-third
      regain their pre-fracture level of physical functioning and ADL ability. After hip fracture,
      the loss of independence, and further decrease in ADL ability often persists beyond three
      months after surgery. This increases the risk of social isolation, depression and thus a
      decrease in Quality of Life (QoL). Therefore, the investigators want to evaluate whether an
      activity-based rehabilitation intervention across sectors is feasible and influences this
      fragile group of patients. The investigators hope to increase the ability to safely and
      independently perform ADL in elderly with hip fractures, and thereby enhance their
      health-related QoL.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Activity-based intervention
primary purpose: Other
masking: None (Open Label)
measure: Assessment of Motor and Process Skills
time frame: Change from baseline at motor and process skills 3 months after baseline testing
description: The assessment measures the quality of a person's activity of daily living task performance. An observational assessment that allows for evaluation of change in motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living. The instrument consists of 16 motor and 20 process skill abilities that are rated on a 4-point scale, In all, 36 discrete ratings of motor and process skills are made during observation.
measure: European Quality of Life Questionnaire
time frame: at baseline and 3 months after baseline testing
description: A survey collecting information about health related quality of life comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
measure: Verbal Rating Scale
time frame: at baseline and 3 months after baseline testing
description: An assessment measuring the intensity of pain. The patient chooses one of those: none, mild, moderate or severe.
measure: Occupational Balance Questionnaire
time frame: at baseline and 3 months after baseline testing
description: An assessment that measures the patients satisfaction with the amount and variation of occupations; . It consists of 13 items measured on six-step ordinal scales. The patient chooses one of those: Disagree, partly disagree, partly agree or agree.
measure: Satisfaction with daily occupations
time frame: at baseline and 3 months after baseline testing
description: An instrument measuring satisfaction with everyday occupations addressing four areas of everyday occupations: work and work-related occupations, leisure occupations, domestic occupations and self-care. The patient chooses on a scale from 1 to 7. 1 = Not satisfied to 7 = Very satisfied.
measure: Cumulated Ambulation Score
time frame: at baseline
description: The Cumulated Ambulation Score is evaluating patients' basic mobility (getting in and out of bed, sit-to-stand from a chair and walking). Each of the three activities is scored from 0-2, resulting in a daily score of 0-6.
measure: New Mobility Score
time frame: at baseline and 3 months after baseline testing
description: The New Mobility Score is a composite score of the patient's ability to perform: indoor walking, outdoor walking and shopping, providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function, resulting in a total score from 0 to 9, with nine indicating a high prefracture functional level.
measure: Functional Recovery Score
time frame: at baseline and 3 months after baseline testing
description: Functional Recovery Score assess the level of function with eleven-items comprised of three main components: basic activities of daily living assessed by four items, instrumental activities of daily living assessed by six items, and mobility assessed by one item. Basic activities of daily living comprise 44 percent of the score; instrumental activities of daily living comprise 23 percent, and mobility comprises 33 percent. Complete independence in basic and instrumental activities of daily living and mobility results in a score of 100 percent.
arm group label: Enhanced rehabilitation
arm group type: Other
intervention type: Other
intervention name: HIP fracture REhabilitation Programme for the elderly with hip fractures
description: Eight-week activity-based intervention for elderly with hip fractures; one intervention during the hospital stay, four interventions at the elderly's municipality.
arm group label: Enhanced rehabilitation
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev and Gentofte Hospital
investigator full name: Carsten Bogh Juhl
investigator title: Principal Investigator
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: No