<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/NCT01681056</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1134-1994</org_study_id>
    <nct_id>NCT01681056</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients</brief_title>
  <acronym>ESAQoGe</acronym>
  <official_title>Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality&#xD;
      of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is&#xD;
      quality of life.&#xD;
&#xD;
      The hypothesis of this study is that autosuggestion will increase geriatric patient's quality&#xD;
      of life based on its impact to psycho-neuro-endocrine-immune pathways.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Geriatric patients diagnosed with multipathology after getting information and signing&#xD;
      informed consent will be included in this trial. Autosuggestion was created by patients&#xD;
      according to their preferences, modified by researcher to accomplish autosuggestion&#xD;
      principles, recorded in a tape to be heard by walkman daily for 30 days. Intervention and&#xD;
      control groups received usual standard medical therapy.&#xD;
&#xD;
      Baseline data were collected within one week after admission. Then the subject will be&#xD;
      followed up for 30 days. Primary outcome was quality of life measured by COOP chart, analyze&#xD;
      using on treatment analysis. Secondary outcomes were serum cortisol, interleukin-2,&#xD;
      interleukin-6, IFN-ϒ (Interferon gamma), and N Acetyl Aspartat/ creatine ratio in limbic and&#xD;
      paralimbic system by Magnetic Resonance Spectroscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">May 2011</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>30 days</time_frame>
    <description>Measured by COOP chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Cortisol (ng/mL)</measure>
    <time_frame>30 days</time_frame>
    <description>Change from baseline in Serum Cortisol concentration (ng/mL) measured by Radioimmunoassay method at 08.00-09.00 am.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-2 (pg/mL)</measure>
    <time_frame>30 days</time_frame>
    <description>Change from baseline in Interleukin-2 concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-6 (pg/mL)</measure>
    <time_frame>30 days</time_frame>
    <description>Change from baseline in Interleukin-6 concentration(pg/mL) measured by ELISA method at 08.00-09.00 am.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interferon Gamma (pg/mL)</measure>
    <time_frame>30 days</time_frame>
    <description>Change from baseline in Interferon Gamma concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system (amygdala, hippocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)</measure>
    <time_frame>30 days</time_frame>
    <description>Ratio change from baseline by Magnetic Resonance Spectroscopy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Quality of Life for Geriatric Patients.</condition>
  <arm_group>
    <arm_group_label>Autosuggestion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard medical theraphy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Autosuggestion for 30 days</intervention_name>
    <arm_group_label>Autosuggestion</arm_group_label>
    <other_name>Self talk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: ≥ 60 years old with multipathology, inpatients&#xD;
&#xD;
          -  Not in steroid therapy&#xD;
&#xD;
          -  Could communicate (Karnofsky score: 40% or Zubrod/WHO score: 3)&#xD;
&#xD;
          -  Cooperative&#xD;
&#xD;
          -  Willing to go through all of the research steps.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke&#xD;
&#xD;
          -  Multiple Sclerosis&#xD;
&#xD;
          -  Brain Tumour&#xD;
&#xD;
          -  Using Pace maker&#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_official>
    <last_name>Nina K Sari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indonesia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Cipto Mangunkusumo Hospital</name>
      <address>
        <city>Jakarta</city>
        <state>DKI Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Nina Kemala Sari, MD</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>autosuggestion</keyword>
  <keyword>quality of life</keyword>
  <keyword>geriatric</keyword>
  <keyword>serum cortisol</keyword>
  <keyword>Interferon gamma</keyword>
  <keyword>interleukin-2</keyword>
  <keyword>interleukin-6</keyword>
  <keyword>neuroplasticity</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/NCT01681056
org study id: U1111-1134-1994
nct id: NCT01681056
lead sponsor: 
has dmc: Yes
The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality
      of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is
      quality of life.

      The hypothesis of this study is that autosuggestion will increase geriatric patient's quality
      of life based on its impact to psycho-neuro-endocrine-immune pathways.
Geriatric patients diagnosed with multipathology after getting information and signing
      informed consent will be included in this trial. Autosuggestion was created by patients
      according to their preferences, modified by researcher to accomplish autosuggestion
      principles, recorded in a tape to be heard by walkman daily for 30 days. Intervention and
      control groups received usual standard medical therapy.

      Baseline data were collected within one week after admission. Then the subject will be
      followed up for 30 days. Primary outcome was quality of life measured by COOP chart, analyze
      using on treatment analysis. Secondary outcomes were serum cortisol, interleukin-2,
      interleukin-6, IFN-ϒ (Interferon gamma), and N Acetyl Aspartat/ creatine ratio in limbic and
      paralimbic system by Magnetic Resonance Spectroscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Quality of Life
time frame: 30 days
description: Measured by COOP chart
measure: Serum Cortisol (ng/mL)
time frame: 30 days
description: Change from baseline in Serum Cortisol concentration (ng/mL) measured by Radioimmunoassay method at 08.00-09.00 am.
measure: Interleukin-2 (pg/mL)
time frame: 30 days
description: Change from baseline in Interleukin-2 concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.
measure: Interleukin-6 (pg/mL)
time frame: 30 days
description: Change from baseline in Interleukin-6 concentration(pg/mL) measured by ELISA method at 08.00-09.00 am.
measure: Interferon Gamma (pg/mL)
time frame: 30 days
description: Change from baseline in Interferon Gamma concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.
measure: N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system (amygdala, hippocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)
time frame: 30 days
description: Ratio change from baseline by Magnetic Resonance Spectroscopy.
arm group label: Autosuggestion
arm group type: Experimental
arm group label: Standard medical theraphy
arm group type: No Intervention
intervention type: Behavioral
intervention name: Autosuggestion for 30 days
arm group label: Autosuggestion
other name: Self talk
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Nina K Sari, MD
role: Principal Investigator
affiliation: Indonesia University
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Nina Kemala Sari, MD
investigator title: Medical Doctor