Taiwan Health Promotion Intervention Study for Elders

Not Applicable

Completed

• Conditions: Cognitive Impairment; Frail Elderly Syndrome; Cognitive Decline
• Interventions: Behavioral: Active control; Behavioral: Multidomain intervention

• Registration Number: NCT03056768
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

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.

Study Timeline

• Study Start: 2014-08-30
• Primary Completion: 2015-10-05
• Study Completion: 2016-07-24
• Status Verified: 2017-02
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-02-14
• Study First Posted: 2017-02-17
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1080

Inclusion Criteria

• Prefrail or frail community-dwelling people

Exclusion Criteria

• Institutionalized or ADL dependent
• Diagnosed dementia
• Limited life expectancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active control	Active control	Health promotion provided by local health bureau.
multidomain intervention	Multidomain intervention	1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions)

Primary Outcome Measures

Name	Time	Method
Change from baseline frailty score at 12 months	12 months	Measured by Cardiovascular Health Study(CHS) definition