Taiwan Health Promotion Intervention Study for Elders (THISCE)

Taipei Veterans General Hospital

Status: Completed

Conditions: Cognitive Impairment; Cognitive Decline; Frail Elderly Syndrome

Treatments: Behavioral: Multidomain intervention; Behavioral: Active control

Study type: Interventional

Funder types: Other

Identifiers

NCT03056768

14001A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,080 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Prefrail or frail community-dwelling people

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,080 participants in 2 patient groups

active control

Active Comparator group

Description:

Health promotion provided by local health bureau.

Treatment:

Behavioral: Active control

multidomain intervention

Experimental group

Description:

1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions)

Treatment:

Behavioral: Multidomain intervention