Taiwan Health Promotion Intervention Study for Elders

Cognitive Impairment Clinical Trial

— THISCE  

Official title:

Taiwan Health Promotion Intervention Study for Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056768
• Other study ID #: 14001A
• Status: Completed
• Phase: N/A
• First received: February 2, 2017
• Last updated: February 14, 2017
• Start date: August 30, 2014
• Est. completion date: July 24, 2016

Study information

• Verified date: February 2017
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1080
• Est. completion date: July 24, 2016
• Est. primary completion date: October 5, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Prefrail or frail community-dwelling people

Exclusion Criteria:

• Institutionalized or ADL dependent

• Diagnosed dementia

• Limited life expectancy

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Decline
• Cognitive Impairment
• Frail Elderly Syndrome

Intervention

Behavioral:
• Multidomain intervention
1-year multidomain health promotion (physical, cognitive, nutritional intervention)
• Active control
Health promotion activities provided by local health bureau.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline frailty score at 12 months	Measured by Cardiovascular Health Study(CHS) definition	12 months