Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-14 @ 2:04 AM
Study NCT ID:
NCT03056768
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taiwan Health Promotion Intervention Study for Elders
Sponsor:
Taipei Veterans General Hospital, Taiwan
Organization:
Study Overview
Official Title:
Taiwan Health Promotion Intervention Study for Elders
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THISCE
Brief Summary:
Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people.
Design:
Methods: Randomized controlled trial
Setting:
Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health promotion (physical, cognitive, nutritional intervention)
Measurements:
Primary outcome includes frailty status and cognitive performance. Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; All the variables were measured at 0, 6, 12 months. The effect of intervention was investigated by intention-to-treat analysis.
Design:
Methods: Randomized controlled trial
Setting:
Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health promotion (physical, cognitive, nutritional intervention)
Measurements:
Primary outcome includes frailty status and cognitive performance. Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; All the variables were measured at 0, 6, 12 months. The effect of intervention was investigated by intention-to-treat analysis.
Detailed Description:
Eligibility criteria includes: community-dwelling older people aged 65 or older, and those with confirmed diagnosis of dementia or dependent on activities of daily living were excluded.
Primary outcome includes frailty status measured by CHS frailty score. general and sub-domain cognitive performance measured by Montreal Cognitive Assessment (MoCA). Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; which were evaluated by 5-item Geriatric Depression scale(GDS-5), Mini-nutrition Assessment(MNA), and instrumental activities of daily living (IADL) individually.
Primary outcome includes frailty status measured by CHS frailty score. general and sub-domain cognitive performance measured by Montreal Cognitive Assessment (MoCA). Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; which were evaluated by 5-item Geriatric Depression scale(GDS-5), Mini-nutrition Assessment(MNA), and instrumental activities of daily living (IADL) individually.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: