<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/NCT03304301</url>
  </required_header>
  <id_info>
    <org_study_id>104114</org_study_id>
    <nct_id>NCT03304301</nct_id>
  </id_info>
  <brief_title>Effect of Sunlight Exposure and Outdoor Activities on Depression, Cognition and Quality of Life in the Elderly</brief_title>
  <official_title>Effect of Sunlight Exposure and Outdoor Activities on Improving the Depression, Cognition and Quality of Life of the Institutionalized Elderly: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiayi Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chiayi Christian 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>
      Background: The transition to long-term care facility can be a stressful and emotional event&#xD;
      for the elderly. The evidences showed that the prevalence of depression and the cognition&#xD;
      impairment were higher in the institutionalized elderly than the community dwelling elderly.&#xD;
      It could affect the quality of life of the elderly and increase risk of mortality.&#xD;
&#xD;
      Purpose: The aim of the study is to evaluate the effect of outdoor activities and sunlight&#xD;
      exposure on depression, cognitive function, and quality of life among institutionalized&#xD;
      elderly.&#xD;
&#xD;
      Method: The design is a randomized control trial. Participants will be randomly allocated to&#xD;
      experimental or control groups by block randomization. In the experimental group,&#xD;
      participants will be encouraged to reduce time spent on bed and bedroom. Nurses, nurse aids&#xD;
      or family will take participants outdoors and exposure their face, hands or arm to sunlight&#xD;
      for 15-30 minutes a day, five days a week for three months (if the UV index is over 8&#xD;
      according to the forecast of Center Weather Bureau, the participants will be asked to stay&#xD;
      inside). In the control group, the participants will receive routine care. The control group&#xD;
      will neither be encouraged to stay outdoors nor limit the chance to exposure to sunlight.&#xD;
&#xD;
      Expected outcome: The expected benefit of the research is to improve the depression,&#xD;
      cognitive function, and quality of life of the institutionalized elderly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2016</start_date>
  <completion_date type="Anticipated">April 12, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 12, 2018</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>Change from baseline depression at 3 months</measure>
    <time_frame>baseline, three month after recruitment</time_frame>
    <description>measured with GDS-15</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline cognitive function at 3 months</measure>
    <time_frame>baseline, three month after recruitment</time_frame>
    <description>measured with SPMSQ</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline quality of life at 3 months</measure>
    <time_frame>baseline, three month after recruitment</time_frame>
    <description>measured with EQ-5D</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Aging</condition>
  <condition>Nursing Homes</condition>
  <condition>Depression in Old Age</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be encouraged to reduce time spent on bed and bedroom. We will also take participants outdoors and expose to sunlight (if the UV index is over 8 according to the forecast of Center Weather Bureau, the participants will be asked to stay inside) five days a week for three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive routine care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>sunlight exposure</intervention_name>
    <description>Participants will be encouraged to reduce time spent on bed and bedroom. We will also take participants outdoors and receiving sunlight exposure (if the UV index is over 8 according to the forecast of Center Weather Bureau, the participants will be asked to stay inside) five days a week for three months</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  resident in the long-term care facility for at least 6 months&#xD;
&#xD;
          -  Barthel Index score is equal or over 20&#xD;
&#xD;
          -  able to communicate&#xD;
&#xD;
          -  life expectancy over 12 months&#xD;
&#xD;
          -  conscious clear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to sunlight&#xD;
&#xD;
          -  diagnosed with skin cancer&#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>LIN TZUCHIA, MASTER</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chiayi christian hospital, Taiwan, R.O.C.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>TZU-CHIA LIN, Master</last_name>
    <phone>+886-5-2765041</phone>
    <phone_ext>1256</phone_ext>
    <email>11518@cych.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>BaoKang Long-Term Care Center</name>
      <address>
        <city>Chia-Yi</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>TZU-CHIA LIN, Master</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 8, 2017</last_update_submitted>
  <last_update_submitted_qc>October 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sunlight exposure</keyword>
  <keyword>institutionalized elderly</keyword>
  <keyword>depression</keyword>
  <keyword>quality of life</keyword>
  <keyword>cognition function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03304301/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03304301
org study id: 104114
nct id: NCT03304301
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: The transition to long-term care facility can be a stressful and emotional event
      for the elderly. The evidences showed that the prevalence of depression and the cognition
      impairment were higher in the institutionalized elderly than the community dwelling elderly.
      It could affect the quality of life of the elderly and increase risk of mortality.

      Purpose: The aim of the study is to evaluate the effect of outdoor activities and sunlight
      exposure on depression, cognitive function, and quality of life among institutionalized
      elderly.

      Method: The design is a randomized control trial. Participants will be randomly allocated to
      experimental or control groups by block randomization. In the experimental group,
      participants will be encouraged to reduce time spent on bed and bedroom. Nurses, nurse aids
      or family will take participants outdoors and exposure their face, hands or arm to sunlight
      for 15-30 minutes a day, five days a week for three months (if the UV index is over 8
      according to the forecast of Center Weather Bureau, the participants will be asked to stay
      inside). In the control group, the participants will receive routine care. The control group
      will neither be encouraged to stay outdoors nor limit the chance to exposure to sunlight.

      Expected outcome: The expected benefit of the research is to improve the depression,
      cognitive function, and quality of life of the institutionalized elderly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline depression at 3 months
time frame: baseline, three month after recruitment
description: measured with GDS-15
measure: Change from baseline cognitive function at 3 months
time frame: baseline, three month after recruitment
description: measured with SPMSQ
measure: Change from baseline quality of life at 3 months
time frame: baseline, three month after recruitment
description: measured with EQ-5D
arm group label: experimental group
arm group type: Experimental
description: Participants will be encouraged to reduce time spent on bed and bedroom. We will also take participants outdoors and expose to sunlight (if the UV index is over 8 according to the forecast of Center Weather Bureau, the participants will be asked to stay inside) five days a week for three months.
arm group label: control group
arm group type: No Intervention
description: Participants will receive routine care.
intervention type: Behavioral
intervention name: sunlight exposure
description: Participants will be encouraged to reduce time spent on bed and bedroom. We will also take participants outdoors and receiving sunlight exposure (if the UV index is over 8 according to the forecast of Center Weather Bureau, the participants will be asked to stay inside) five days a week for three months
arm group label: experimental group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: LIN TZUCHIA, MASTER
role: Principal Investigator
affiliation: Chiayi christian hospital, Taiwan, R.O.C.
last name: TZU-CHIA LIN, Master
phone: +886-5-2765041
phone ext: 1256
email: 11518@cych.org.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
provided document: 