<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/NCT01672177</url>
  </required_header>
  <id_info>
    <org_study_id>MOE2010-T2-2-107</org_study_id>
    <nct_id>NCT01672177</nct_id>
  </id_info>
  <brief_title>Self Care for Older Persons in Singapore: An Intervention Study</brief_title>
  <acronym>SCOPE</acronym>
  <official_title>Self Care for Older Persons in Singapore: An Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University of Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of the project is to evaluate a self-care intervention program aimed at&#xD;
      enhancing the ability of mildly disabled and healthy older persons in Singapore to manage&#xD;
      their health.&#xD;
&#xD;
      A secondary aim of the study is to evaluate the effectiveness of training community health&#xD;
      workers located within Senior Activity Centres in Singapore to support the self-care capacity&#xD;
      development amongst older persons in the locale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Singapore is facing a rapidly ageing population due to its changing demographics. One of the&#xD;
      biggest challenges associated with older adults is providing them with adequate and&#xD;
      sustainable health care. There are four main barriers that make it challenging to do so in&#xD;
      this segment of the population: (1) Lack of knowledge of simple coping mechanisms and self&#xD;
      care; (2) inadequate access to care and healthcare; (3) social, economic, and political&#xD;
      exclusion; and (4) declining family support and strains on state services.&#xD;
&#xD;
      This proposal, is to conduct a randomized controlled trial that tests the impact of a&#xD;
      state-of-the-art self care training program focused on teaching older adults how to manage&#xD;
      their health and if present, their diabetes, hypertension or chronic obstructive pulmonary&#xD;
      disease. The training focuses on health promotion, disease prevention, health seeking&#xD;
      behavior, chronic disease management and empowerment. The study period is 18 months with&#xD;
      measurements taken at baseline, 8 months and 18 months. Major events (stroke, myocardial&#xD;
      infarction, end-stage renal disease, hospitalization, deaths) during the study will also be&#xD;
      recorded. A questionnaire assessing functional status (IADL), quality of life (EQ5D),&#xD;
      knowledge and attitude about health care, health seeking behavior, and health status (CIRS-G)&#xD;
      will be used. Anthropometric measures will also be taken to better understand certain aspects&#xD;
      related to the health and physical status of the participants as well as biomarkers such as&#xD;
      the levels of glycosylated hemoglobin (HbA1c), cholesterol (total HDL), triglycerides, blood&#xD;
      pressure and peak expiratory flow.&#xD;
&#xD;
      The main goal of the study is to improve each individual score and to measure improvement in&#xD;
      overall quality of life and mental well-being. The total sample size for this pilot study is&#xD;
      400 older persons (above 55 years of age) randomly sampled from Tiong Bahru/Bukit Merah and&#xD;
      Ang Mo Kio. The health care training will be based in Senior Activity Centres (SACs) located&#xD;
      in HDB blocks. The investigators will select 12 SACs and randomly assign 6 SACs to the&#xD;
      intervention group and 6 SACs to the control group. All twelve groups will receive a baseline&#xD;
      assessment of physical and mental health status and a follow-up at 8 and 18 months. Two&#xD;
      community health trainers (CHT) will be assigned to each of the intervention groups. These&#xD;
      CHTs will have been trained by personnel at the Tsao Foundation to conduct the training&#xD;
      protocol and collect data from participants. The intervention group will then receive the&#xD;
      health care training once a week for 2 hours over a period of seven-eight months (56 hours&#xD;
      total). The content of training materials focuses on health promotion, disease prevention,&#xD;
      health seeking behavior, chronic disease management, and anti-stigmatization. In addition,&#xD;
      each participant, regardless of randomization, will be given an event diary at baseline. The&#xD;
      diary will be used to record any health related events that occur during the course of the&#xD;
      study. Such events would include visits to GPs or traditional medicine practitioners,&#xD;
      purchasing medications, hospitalization, etc.&#xD;
&#xD;
      The investigators hypothesize that the study will demonstrate the following: 1) Improve&#xD;
      chronic disease outcomes for individuals presenting with these diseases: hypertension (20%&#xD;
      decrease in systolic blood pressure), diabetes (1% decrease in HBA1C levels), and COPD (10%&#xD;
      increase in peak expiratory flow) over the 18-month study period. 2) Improve quality of life&#xD;
      of participants and their caregivers. 3) Improve knowledge, behaviours and attitudes towards&#xD;
      health care utilization. 4) Develop a community health worker capacity in low-income&#xD;
      settings. 5) Reduce the number of hospitalizations, outpatient and emergency visits in the&#xD;
      intervention group.&#xD;
&#xD;
      This pilot study will also allow the investigators to test their methods for recruitment,&#xD;
      training, and evaluation of the self-care training program. If successful, this study will&#xD;
      provide evidence that older adults in the intervention group can more effectively manage&#xD;
      their own health care and avert or delay the onset of disability compared to older adults in&#xD;
      the control group. One of the long term goals is to replicate this study in Cambodia, India,&#xD;
      Indonesia, and Vietnam. The investigators have identified academic and practice partners in&#xD;
      each of these countries who have expressed an interest in the project and donors are awaiting&#xD;
      the results from this pilot study before funding the regional components.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Measures</measure>
    <time_frame>18 months</time_frame>
    <description>The primary outcome measure is a composite of the change in the following measures: 1)Systolic BP; 2)HbA1C; and 3)normalized peak flow. The null hypothesis is that there is no difference between intervention and control in any of the measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved Quality of Life</measure>
    <time_frame>18 months</time_frame>
    <description>Improve quality of life of participants and their caregivers using a validated measure (EQ-5D).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Health Trainer</measure>
    <time_frame>18 months</time_frame>
    <description>Develop a community health trainer capacity in low-income settings as assessed by numbers of individuals who successfully complete the health trainer education.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>18 months</time_frame>
    <description>Reduce the number of hospitalizations, outpatient and emergency visits in the intervention group vs control.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Health Services, Geriatric</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals in the control group will not receive any training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals in the intervention group will receive two hour long weekly training sessions for seven to eight months. The content of the training focuses on health promotion, health seeking behaviours and chronic disease management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Chronic disease self-management training</intervention_name>
    <description>Those in the intervention group will receive two hour long weekly training sessions for seven-eight months (a total of 56 hours of training).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 55 and above&#xD;
&#xD;
          -  Age 21 or above for CHTs&#xD;
&#xD;
          -  No cognitive impairment as justified by AMT&#xD;
&#xD;
          -  No Activities of Daily Living (ADL)Limitations preventing them from coming to&#xD;
             questionnaire interviews, health screenings, and/or weekly health trainings.&#xD;
&#xD;
          -  Not severely ill ; not on dialysis, chemotherapy or psychiatric medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below 55 years of age&#xD;
&#xD;
          -  Cognitively impaired&#xD;
&#xD;
          -  Severely depressed&#xD;
&#xD;
          -  With ADLs preventing them from coming to questionnaire interviews, health screenings,&#xD;
             and/or weekly health trainings.&#xD;
&#xD;
          -  Severely ill ; on dialysis, chemotherapy or psychiatric medication&#xD;
&#xD;
          -  Those who refused to have their biomarkers taken (applies to both intervention and&#xD;
             non-intervention group)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 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>Redhill SilverACE</name>
      <address>
        <city>Singapore</city>
        <zip>150071</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moral Seniors Activity Centre (Redhill)</name>
      <address>
        <city>Singapore</city>
        <zip>150089</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moral Neighbourhood Link Bukit Merah View/Tanjong Pagar FSC</name>
      <address>
        <city>Singapore</city>
        <zip>150118</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kreta Ayer Seniors Activity Centre (Chin Swee)</name>
      <address>
        <city>Singapore</city>
        <zip>160051</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Seniors Activity Centre</name>
      <address>
        <city>Singapore</city>
        <zip>160105</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kreta Ayer Senior Activity Centre (Jalan Kukoh)</name>
      <address>
        <city>Singapore</city>
        <zip>162008</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AWWA Seniors Activity Centre</name>
      <address>
        <city>Singapore</city>
        <zip>560123</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ang Mo Kio Family Services Centre</name>
      <address>
        <city>Singapore</city>
        <zip>560230</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Care Network Senior Activity Centre @Teck Ghee 420</name>
      <address>
        <city>Singapore</city>
        <zip>560420</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Corner Toa Payoh</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lion Befrienders/TOUCH</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moral Neighbourhood Link Telok Blangah</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>April 15, 2015</last_update_submitted>
  <last_update_submitted_qc>April 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 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 and Systems Research</investigator_title>
  </responsible_party>
  <keyword>Geriatrics</keyword>
  <keyword>Aged</keyword>
  <keyword>Aging</keyword>
  <keyword>Chronic disease</keyword>
  <keyword>Self management</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/NCT01672177
org study id: MOE2010-T2-2-107
nct id: NCT01672177
lead sponsor: 
has dmc: No
The main aim of the project is to evaluate a self-care intervention program aimed at
      enhancing the ability of mildly disabled and healthy older persons in Singapore to manage
      their health.

      A secondary aim of the study is to evaluate the effectiveness of training community health
      workers located within Senior Activity Centres in Singapore to support the self-care capacity
      development amongst older persons in the locale.
Singapore is facing a rapidly ageing population due to its changing demographics. One of the
      biggest challenges associated with older adults is providing them with adequate and
      sustainable health care. There are four main barriers that make it challenging to do so in
      this segment of the population: (1) Lack of knowledge of simple coping mechanisms and self
      care; (2) inadequate access to care and healthcare; (3) social, economic, and political
      exclusion; and (4) declining family support and strains on state services.

      This proposal, is to conduct a randomized controlled trial that tests the impact of a
      state-of-the-art self care training program focused on teaching older adults how to manage
      their health and if present, their diabetes, hypertension or chronic obstructive pulmonary
      disease. The training focuses on health promotion, disease prevention, health seeking
      behavior, chronic disease management and empowerment. The study period is 18 months with
      measurements taken at baseline, 8 months and 18 months. Major events (stroke, myocardial
      infarction, end-stage renal disease, hospitalization, deaths) during the study will also be
      recorded. A questionnaire assessing functional status (IADL), quality of life (EQ5D),
      knowledge and attitude about health care, health seeking behavior, and health status (CIRS-G)
      will be used. Anthropometric measures will also be taken to better understand certain aspects
      related to the health and physical status of the participants as well as biomarkers such as
      the levels of glycosylated hemoglobin (HbA1c), cholesterol (total HDL), triglycerides, blood
      pressure and peak expiratory flow.

      The main goal of the study is to improve each individual score and to measure improvement in
      overall quality of life and mental well-being. The total sample size for this pilot study is
      400 older persons (above 55 years of age) randomly sampled from Tiong Bahru/Bukit Merah and
      Ang Mo Kio. The health care training will be based in Senior Activity Centres (SACs) located
      in HDB blocks. The investigators will select 12 SACs and randomly assign 6 SACs to the
      intervention group and 6 SACs to the control group. All twelve groups will receive a baseline
      assessment of physical and mental health status and a follow-up at 8 and 18 months. Two
      community health trainers (CHT) will be assigned to each of the intervention groups. These
      CHTs will have been trained by personnel at the Tsao Foundation to conduct the training
      protocol and collect data from participants. The intervention group will then receive the
      health care training once a week for 2 hours over a period of seven-eight months (56 hours
      total). The content of training materials focuses on health promotion, disease prevention,
      health seeking behavior, chronic disease management, and anti-stigmatization. In addition,
      each participant, regardless of randomization, will be given an event diary at baseline. The
      diary will be used to record any health related events that occur during the course of the
      study. Such events would include visits to GPs or traditional medicine practitioners,
      purchasing medications, hospitalization, etc.

      The investigators hypothesize that the study will demonstrate the following: 1) Improve
      chronic disease outcomes for individuals presenting with these diseases: hypertension (20%
      decrease in systolic blood pressure), diabetes (1% decrease in HBA1C levels), and COPD (10%
      increase in peak expiratory flow) over the 18-month study period. 2) Improve quality of life
      of participants and their caregivers. 3) Improve knowledge, behaviours and attitudes towards
      health care utilization. 4) Develop a community health worker capacity in low-income
      settings. 5) Reduce the number of hospitalizations, outpatient and emergency visits in the
      intervention group.

      This pilot study will also allow the investigators to test their methods for recruitment,
      training, and evaluation of the self-care training program. If successful, this study will
      provide evidence that older adults in the intervention group can more effectively manage
      their own health care and avert or delay the onset of disability compared to older adults in
      the control group. One of the long term goals is to replicate this study in Cambodia, India,
      Indonesia, and Vietnam. The investigators have identified academic and practice partners in
      each of these countries who have expressed an interest in the project and donors are awaiting
      the results from this pilot study before funding the regional components.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Clinical Measures
time frame: 18 months
description: The primary outcome measure is a composite of the change in the following measures: 1)Systolic BP; 2)HbA1C; and 3)normalized peak flow. The null hypothesis is that there is no difference between intervention and control in any of the measures.
measure: Improved Quality of Life
time frame: 18 months
description: Improve quality of life of participants and their caregivers using a validated measure (EQ-5D).
measure: Community Health Trainer
time frame: 18 months
description: Develop a community health trainer capacity in low-income settings as assessed by numbers of individuals who successfully complete the health trainer education.
measure: Healthcare Utilization
time frame: 18 months
description: Reduce the number of hospitalizations, outpatient and emergency visits in the intervention group vs control.
arm group label: Control
arm group type: No Intervention
description: Individuals in the control group will not receive any training.
arm group label: Intervention
arm group type: Experimental
description: Individuals in the intervention group will receive two hour long weekly training sessions for seven to eight months. The content of the training focuses on health promotion, health seeking behaviours and chronic disease management.
intervention type: Behavioral
intervention name: Chronic disease self-management training
description: Those in the intervention group will receive two hour long weekly training sessions for seven-eight months (a total of 56 hours of training).
arm group label: Intervention
criteria: 
gender: All
minimum age: 55 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: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Singapore
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 and Systems Research