NCT03304301

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2018

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

October 2, 2017

Last Update Submit

October 8, 2017

Conditions

Keywords

sunlight exposureinstitutionalized elderlydepressionquality of lifecognition function

Outcome Measures

Primary Outcomes (1)

  • Change from baseline depression at 3 months

    measured with GDS-15

    baseline, three month after recruitment

Secondary Outcomes (1)

  • Change from baseline cognitive function at 3 months

    baseline, three month after recruitment

Other Outcomes (1)

  • Change from baseline quality of life at 3 months

    baseline, three month after recruitment

Study Arms (2)

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

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

experimental group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • allergy to sunlight
  • diagnosed with skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BaoKang Long-Term Care Center

Chiayi City, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionDepression

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • LIN TZUCHIA, MASTER

    Chiayi christian hospital, Taiwan, R.O.C.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TZU-CHIA LIN, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 9, 2017

Study Start

June 30, 2016

Primary Completion

January 12, 2018

Study Completion

April 12, 2018

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations