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Effect of Sunlight Exposure and Outdoor Activities on Depression, Cognition and Quality of Life in the Elderly

Primary Purpose

Aging, Nursing Homes, Depression in Old Age

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
sunlight exposure
Sponsored by
Chiayi Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring sunlight exposure, institutionalized elderly, depression, quality of life, cognition function

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • resident in the long-term care facility for at least 6 months
  • Barthel Index score is equal or over 20
  • able to communicate
  • life expectancy over 12 months
  • conscious clear

Exclusion Criteria:

  • allergy to sunlight
  • diagnosed with skin cancer

Sites / Locations

  • BaoKang Long-Term Care CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm 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.

Participants will receive routine care.

Outcomes

Primary Outcome Measures

Change from baseline depression at 3 months
measured with GDS-15

Secondary Outcome Measures

Change from baseline cognitive function at 3 months
measured with SPMSQ

Full Information

First Posted
October 2, 2017
Last Updated
October 8, 2017
Sponsor
Chiayi Christian Hospital
Collaborators
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT03304301
Brief Title
Effect of Sunlight Exposure and Outdoor Activities on Depression, Cognition and Quality of Life in the Elderly
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2016 (Actual)
Primary Completion Date
January 12, 2018 (Anticipated)
Study Completion Date
April 12, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiayi Christian Hospital
Collaborators
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Nursing Homes, Depression in Old Age, Cognitive Impairment, Quality of Life
Keywords
sunlight exposure, institutionalized elderly, depression, quality of life, cognition function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm 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 Title
control group
Arm Type
No Intervention
Arm Description
Participants will receive routine care.
Intervention Type
Behavioral
Intervention Name(s)
sunlight exposure
Intervention 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
Primary Outcome Measure Information:
Title
Change from baseline depression at 3 months
Description
measured with GDS-15
Time Frame
baseline, three month after recruitment
Secondary Outcome Measure Information:
Title
Change from baseline cognitive function at 3 months
Description
measured with SPMSQ
Time Frame
baseline, three month after recruitment
Other Pre-specified Outcome Measures:
Title
Change from baseline quality of life at 3 months
Description
measured with EQ-5D
Time Frame
baseline, three month after recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: resident in the long-term care facility for at least 6 months Barthel Index score is equal or over 20 able to communicate life expectancy over 12 months conscious clear Exclusion Criteria: allergy to sunlight diagnosed with skin cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TZU-CHIA LIN, Master
Phone
+886-5-2765041
Ext
1256
Email
11518@cych.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LIN TZUCHIA, MASTER
Organizational Affiliation
Chiayi christian hospital, Taiwan, R.O.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
BaoKang Long-Term Care Center
City
Chia-Yi
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TZU-CHIA LIN, Master

12. IPD Sharing Statement

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Effect of Sunlight Exposure and Outdoor Activities on Depression, Cognition and Quality of Life in the Elderly

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