Taiwan Health Promotion Intervention Study for Elders

Study Overview
=================
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.

Official Title
-----------------
Taiwan Health Promotion Intervention Study for Elders

Conditions
-----------------
Frail Elderly Syndrome, Cognitive Impairment, Cognitive Decline

Intervention / Treatment
-----------------
* Behavioral: Multidomain intervention
* Behavioral: Active control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prefrail or frail community-dwelling people Exclusion Criteria: Institutionalized or ADL dependent Diagnosed dementia Limited life expectancy

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active control<br>Health promotion provided by local health bureau. | Behavioral: Active control<br>* Health promotion activities provided by local health bureau.<br>|
| Experimental: multidomain intervention<br>1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions) | Behavioral: Multidomain intervention<br>* 1-year multidomain health promotion (physical, cognitive, nutritional intervention)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline frailty score at 12 months | Measured by Cardiovascular Health Study(CHS) definition | 12 months |