<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/NCT01713543</url>
  </required_header>
  <id_info>
    <org_study_id>HSRG10MAY002</org_study_id>
    <nct_id>NCT01713543</nct_id>
  </id_info>
  <brief_title>Community-based Falls Prevention Program for the Elderly</brief_title>
  <official_title>Multifactorial, Evidence-based Program of Screening, Risk Modification and Physical Therapy to Prevent Falls Among Vulnerable Elderly Recently Discharged From Hospital to the Community.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke-NUS Graduate Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Promotion Board, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Agency for Integrated Care, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jurong Health Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University of Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Falls are the leading cause of injury among older adults in Singapore, but falls&#xD;
      among the elderly can be preventable and the risks are predictable. Translating this&#xD;
      understanding of falls etiology into an integrated clinical and public health program that is&#xD;
      accessible to the elderly is a critical health services delivery challenge.&#xD;
&#xD;
      Hypothesis: An evidence-based program of screening, risk modification and physical therapy&#xD;
      delivered in a community setting will reduce recurrent falls incidence among a high-risk&#xD;
      group of elderly recently discharged to the community.&#xD;
&#xD;
      Methodology: This randomized controlled trial targets patients seen at Emergency Department&#xD;
      (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged&#xD;
      to home. Upon signing the informed consent form, the participants will be followed up for&#xD;
      nine months from the baseline assessment during which the participants are randomized into&#xD;
      either a control or the intervention group. The participants in the intervention group will&#xD;
      be provided with a multifactorial program of screening, risk modification and physical&#xD;
      therapy focused on progressive strength, balance, and gait training either as an&#xD;
      individualized program or a group setting in the community for the first three months from&#xD;
      the date of randomization. The number of recurrent falls will be monitored via a falls&#xD;
      prevention diary maintained by (or for) each participant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
      To develop and demonstrate the feasibility and effectiveness of a multifactorial,&#xD;
      community-based falls prevention program of screening, risk modification, and progressive&#xD;
      physical therapy that targets vulnerable elderly Singaporeans at high-risk of falls.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      This two-year, multi-center, two-arm, parallel group, randomized controlled trial will be&#xD;
      divided into three phases: (1) pre-study, (2) intervention, and (3) analysis.&#xD;
&#xD;
      During the pre-study phase, overseas experts will train local physiotherapists and community&#xD;
      health workers on how to administer and deliver the falls prevention program. Engaging&#xD;
      hospital-based physiotherapists to deliver the home-based assessments and exercise programs&#xD;
      will maximize the likelihood of long-term sustainability of the intervention program. In&#xD;
      addition, manuals will be developed for physiotherapists to guide the evaluation risk factor&#xD;
      assessments, home environment assessments, appropriate referrals to different health care&#xD;
      providers, and selection of exercise programs that will be progressive, challenging and of&#xD;
      optimal intensity and durations. Manuals for risk factor assessments will be shared with the&#xD;
      blinded assessors.&#xD;
&#xD;
      The intervention phase will be divided into two phases: a three-month &quot;Active Intervention&#xD;
      Phase&quot; and a six-month &quot;Maintenance Phase.&quot; In the beginning of the active intervention&#xD;
      phase, the participants in the intervention group will receive a detailed falls risk&#xD;
      assessment at the baseline assessment by a physiotherapist. The risk factors that will be&#xD;
      assessed are the following:&#xD;
&#xD;
        1. Poor vision: Referral to ophthalmologist for correction&#xD;
&#xD;
        2. Polypharmacy: Referral to AIC for management of medications if use of five or more&#xD;
           medications&#xD;
&#xD;
        3. Environmental Hazards: Caregiver education and suitable recommendations according to the&#xD;
           CDC guidelines to modify risk such as removal of rugs, change to safer footwear, use of&#xD;
           non-slip bath mats, additional lighting at night.&#xD;
&#xD;
        4. Deficiencies in gait, balance or mobility: Physiotherapist-supervised program of gait&#xD;
           training, balance and strengthening exercises In the analysis phase, the collected data&#xD;
           will be analyzed. The primary outcome measure of the study is the number of fallers over&#xD;
           the entire study period. The number of falls will be captured by a falls prevention&#xD;
           diary maintained by (or for) each participant.&#xD;
&#xD;
      Procedures:&#xD;
&#xD;
      The elderly seen at ED for a fall or fall-related injury will be screened for participation&#xD;
      of the study. Once the consent is taken, all study participants will be given an assessment&#xD;
      by a physiotherapist at baseline which assesses sociodemographic characteristics, functional&#xD;
      status measured by the Short Physical Performance Battery (SPPB), two-minute walk test,&#xD;
      history of falls, cognitive impairment measured by the Montreal Cognitive Assessment (MoCA),&#xD;
      quality of life (EQ-5D-5L and EQ-VAS), health care utilization, and medical history&#xD;
      (polypharmacy, orthostatic vital signs, and self-reporting eyesight and hearing).&#xD;
&#xD;
      At the end of baseline assessment, the participants will be assigned either a control or the&#xD;
      intervention group. Before the start of the exercise sessions, the participants in the&#xD;
      intervention group will. Need to complete Physical Activity Readiness Questionnaire (PAR-Q)&#xD;
      and a medical evaluation by a physician to ensure that the participants are fit for physical&#xD;
      activity. Based on the SPPB score at baseline assessment, participants will be categorized as&#xD;
      either high-risk (SPPB&lt;6) or low-to-moderate-risk (SPPB&gt;6) for falls. High-risk patients will&#xD;
      be given an individualized PT-supervised program of physical therapy that specifically&#xD;
      targets impairments that interfere with engaging in exercise in group setting. The goal of&#xD;
      the tailored physical therapy sessions is to modify impairments and transition these patients&#xD;
      to an evidence-based exercise program. Low-to-moderate-risk patients will be directly&#xD;
      enrolled into an evidence-based group exercise program. The group exercise programs will be&#xD;
      offered as one-hour sessions, twice weekly over the intervention period. At the end of the&#xD;
      active intervention phase, these participants will transition to a maintenance phase in which&#xD;
      they will be encouraged to continue with the exercise on their own and will also be referred&#xD;
      to the Health Promotion Board's STEP program.&#xD;
&#xD;
      The participants will be asked at the end of the active intervention phase (three months from&#xD;
      the date of randomization) and at the end of the study period (nine months from the date of&#xD;
      randomization) about their functional status, history of falls, cognitive impairment, quality&#xD;
      of life, health care utilization, and medical history by the blinded assessors. Recurrent&#xD;
      falls incidence will be monitored by participants' self-reporting monthly falls diary as well&#xD;
      as monthly phone calls conducted by the study coordinator during the entire study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of fallers who have fallen at least once during the 9-month study period</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of injurious falls and healthcare utilization</measure>
    <time_frame>9 months</time_frame>
    <description>Injurious falls are the falls that resulted in participants' seeking medical attention or restricting their daily activities for at least 48 hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">354</enrollment>
  <condition>Accidental Falls</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consists of a tailored physical therapy focused on progressive strength, balance and gait training for a period of 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care by physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical therapy</intervention_name>
    <description>Tailored physical therapy sessions to modify impairments in balance and/or gait and to transition high-risk participants to an evidence-based group exercise program.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Falls Prevention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 65 years&#xD;
&#xD;
          -  Seen in the Emergency Department for a fall or injury related to a fall&#xD;
&#xD;
          -  Able to follow 3 step commands&#xD;
&#xD;
          -  Singapore citizen or Permanent Resident&#xD;
&#xD;
          -  Living at home upon discharge&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
          -  If admitted to the hospital, the illness or disability is one from which they are&#xD;
             expected to recover basic ADLs or weight bearing of the lower extremity within the&#xD;
             next month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those patients with severe physical and/or mental impairments which preclude&#xD;
             participation in a program of physical therapy (as determined by a primary physician)&#xD;
             will NOT be eligible for participation.&#xD;
&#xD;
          -  Unable to participate in the exercise program due to conflicting schedules (e.g.&#xD;
             full-time employment, on dialysis)&#xD;
&#xD;
          -  Serious life limiting illness&#xD;
&#xD;
          -  Patients seen at ED due to road traffic accidents&#xD;
&#xD;
          -  Unable to walk even with assistance&#xD;
&#xD;
          -  Not community dwelling prior to ED visit&#xD;
&#xD;
          -  Total blindness&#xD;
&#xD;
          -  Needs emergency inpatient surgery and, if admitted to the hospital, the illness or&#xD;
             disability is one from which they are not expected to recover basic ADLs or weight&#xD;
             bearing in the lower extremity within the next one month.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David B Matchar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke-NUS Graduate Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.</citation>
    <PMID>17996052</PMID>
  </reference>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>September 4, 2015</last_update_submitted>
  <last_update_submitted_qc>September 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Singapore</investigator_affiliation>
    <investigator_full_name>Dr. David Matchar</investigator_full_name>
    <investigator_title>Professor and Director, Program in Health Services &amp; Systems Research, Duke-NUS</investigator_title>
  </responsible_party>
  <keyword>falls</keyword>
  <!-- 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/NCT01713543
org study id: HSRG10MAY002
nct id: NCT01713543
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Background: Falls are the leading cause of injury among older adults in Singapore, but falls
      among the elderly can be preventable and the risks are predictable. Translating this
      understanding of falls etiology into an integrated clinical and public health program that is
      accessible to the elderly is a critical health services delivery challenge.

      Hypothesis: An evidence-based program of screening, risk modification and physical therapy
      delivered in a community setting will reduce recurrent falls incidence among a high-risk
      group of elderly recently discharged to the community.

      Methodology: This randomized controlled trial targets patients seen at Emergency Department
      (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged
      to home. Upon signing the informed consent form, the participants will be followed up for
      nine months from the baseline assessment during which the participants are randomized into
      either a control or the intervention group. The participants in the intervention group will
      be provided with a multifactorial program of screening, risk modification and physical
      therapy focused on progressive strength, balance, and gait training either as an
      individualized program or a group setting in the community for the first three months from
      the date of randomization. The number of recurrent falls will be monitored via a falls
      prevention diary maintained by (or for) each participant.
Objective:

      To develop and demonstrate the feasibility and effectiveness of a multifactorial,
      community-based falls prevention program of screening, risk modification, and progressive
      physical therapy that targets vulnerable elderly Singaporeans at high-risk of falls.

      Methodology:

      This two-year, multi-center, two-arm, parallel group, randomized controlled trial will be
      divided into three phases: (1) pre-study, (2) intervention, and (3) analysis.

      During the pre-study phase, overseas experts will train local physiotherapists and community
      health workers on how to administer and deliver the falls prevention program. Engaging
      hospital-based physiotherapists to deliver the home-based assessments and exercise programs
      will maximize the likelihood of long-term sustainability of the intervention program. In
      addition, manuals will be developed for physiotherapists to guide the evaluation risk factor
      assessments, home environment assessments, appropriate referrals to different health care
      providers, and selection of exercise programs that will be progressive, challenging and of
      optimal intensity and durations. Manuals for risk factor assessments will be shared with the
      blinded assessors.

      The intervention phase will be divided into two phases: a three-month "Active Intervention
      Phase" and a six-month "Maintenance Phase." In the beginning of the active intervention
      phase, the participants in the intervention group will receive a detailed falls risk
      assessment at the baseline assessment by a physiotherapist. The risk factors that will be
      assessed are the following:

        1. Poor vision: Referral to ophthalmologist for correction

        2. Polypharmacy: Referral to AIC for management of medications if use of five or more
           medications

        3. Environmental Hazards: Caregiver education and suitable recommendations according to the
           CDC guidelines to modify risk such as removal of rugs, change to safer footwear, use of
           non-slip bath mats, additional lighting at night.

        4. Deficiencies in gait, balance or mobility: Physiotherapist-supervised program of gait
           training, balance and strengthening exercises In the analysis phase, the collected data
           will be analyzed. The primary outcome measure of the study is the number of fallers over
           the entire study period. The number of falls will be captured by a falls prevention
           diary maintained by (or for) each participant.

      Procedures:

      The elderly seen at ED for a fall or fall-related injury will be screened for participation
      of the study. Once the consent is taken, all study participants will be given an assessment
      by a physiotherapist at baseline which assesses sociodemographic characteristics, functional
      status measured by the Short Physical Performance Battery (SPPB), two-minute walk test,
      history of falls, cognitive impairment measured by the Montreal Cognitive Assessment (MoCA),
      quality of life (EQ-5D-5L and EQ-VAS), health care utilization, and medical history
      (polypharmacy, orthostatic vital signs, and self-reporting eyesight and hearing).

      At the end of baseline assessment, the participants will be assigned either a control or the
      intervention group. Before the start of the exercise sessions, the participants in the
      intervention group will. Need to complete Physical Activity Readiness Questionnaire (PAR-Q)
      and a medical evaluation by a physician to ensure that the participants are fit for physical
      activity. Based on the SPPB score at baseline assessment, participants will be categorized as
      either high-risk (SPPB<6) or low-to-moderate-risk (SPPB>6) for falls. High-risk patients will
      be given an individualized PT-supervised program of physical therapy that specifically
      targets impairments that interfere with engaging in exercise in group setting. The goal of
      the tailored physical therapy sessions is to modify impairments and transition these patients
      to an evidence-based exercise program. Low-to-moderate-risk patients will be directly
      enrolled into an evidence-based group exercise program. The group exercise programs will be
      offered as one-hour sessions, twice weekly over the intervention period. At the end of the
      active intervention phase, these participants will transition to a maintenance phase in which
      they will be encouraged to continue with the exercise on their own and will also be referred
      to the Health Promotion Board's STEP program.

      The participants will be asked at the end of the active intervention phase (three months from
      the date of randomization) and at the end of the study period (nine months from the date of
      randomization) about their functional status, history of falls, cognitive impairment, quality
      of life, health care utilization, and medical history by the blinded assessors. Recurrent
      falls incidence will be monitored by participants' self-reporting monthly falls diary as well
      as monthly phone calls conducted by the study coordinator during the entire study period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: The number of fallers who have fallen at least once during the 9-month study period
time frame: 9 months
measure: The number of injurious falls and healthcare utilization
time frame: 9 months
description: Injurious falls are the falls that resulted in participants' seeking medical attention or restricting their daily activities for at least 48 hours.
arm group label: Intervention Group
arm group type: Experimental
description: The intervention consists of a tailored physical therapy focused on progressive strength, balance and gait training for a period of 3 months.
arm group label: Control Group
arm group type: No Intervention
description: Usual care by physician.
intervention type: Other
intervention name: physical therapy
description: Tailored physical therapy sessions to modify impairments in balance and/or gait and to transition high-risk participants to an evidence-based group exercise program.
arm group label: Intervention Group
other name: Falls Prevention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David B Matchar, MD
role: Principal Investigator
affiliation: Duke-NUS Graduate Medical School
facility: 
facility: 
country: Singapore
citation: Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.
PMID: 17996052
responsible party type: Principal Investigator
investigator affiliation: National University of Singapore
investigator full name: Dr. David Matchar
investigator title: Professor and Director, Program in Health Services & Systems Research, Duke-NUS