Effect of Sunlight Exposure and Outdoor Activities on Dep... | NCT03304301

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

NCT03304301

Sponsor

Chiayi Christian Hospital

Status

Unknown status

Last Update Posted

Oct 10, 2017Actual

Enrollment

74Estimated

Phase

Not Applicable

Conditions

Aging
Nursing Homes
Depression in Old Age
Cognitive Impairment
Quality of Life

Interventions

sunlight exposure

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2016Actual

Primary Completion Date

Jan 12, 2018Estimated

Completion Date

Apr 12, 2018Estimated

First Submitted Date

Oct 2, 2017

First Submission Date that Met QC Criteria

Oct 5, 2017

First Posted Date

Oct 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2017

Last Update Posted Date

Oct 10, 2017Actual

Name	Class
National Cheng Kung University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group	Experimental	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.	Behavioral: sunlight exposure
control group	No Intervention	Participants will receive routine care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sunlight exposure	Behavioral	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline depression at 3 months	measured with GDS-15	baseline, three month after recruitment

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline cognitive function at 3 months	measured with SPMSQ	baseline, three month after recruitment

Other Outcomes

Measure	Description	Time Frame
Change from baseline quality of life at 3 months	measured with EQ-5D	baseline, three month after recruitment

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TZU-CHIA LIN, Master	Contact	+886-5-2765041	1256	11518@cych.org.tw

Overall Officials

Name	Affiliation	Role
LIN TZUCHIA, MASTER	Chiayi christian hospital, Taiwan, R.O.C.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BaoKang Long-Term Care Center	Recruiting	Chiayi City			Taiwan

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 2, 2017	Oct 5, 2017	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction
D003863	Depression

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided