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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03304301
Other study ID # 104114
Secondary ID
Status Recruiting
Phase N/A
First received October 2, 2017
Last updated October 8, 2017
Start date June 30, 2016
Est. completion date April 12, 2018

Study information

Verified date October 2017
Source Chiayi Christian Hospital
Contact TZU-CHIA LIN, Master
Phone +886-5-2765041
Email 11518@cych.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date April 12, 2018
Est. primary completion date January 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
sunlight exposure
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

Locations

Country Name City State
Taiwan BaoKang Long-Term Care Center Chia-Yi

Sponsors (2)

Lead Sponsor Collaborator
Chiayi Christian Hospital National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline quality of life at 3 months measured with EQ-5D baseline, three month after recruitment
Primary Change from baseline depression at 3 months measured with GDS-15 baseline, three month after recruitment
Secondary Change from baseline cognitive function at 3 months measured with SPMSQ baseline, three month after recruitment
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