Taiwan Health Promotion Intervention Study for Elders (THISCE)

February 14, 2017 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1080

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prefrail or frail community-dwelling people

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Liang-Kung Chen, MD, PhD, Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2014

Primary Completion (Actual)

October 5, 2015

Study Completion (Actual)

July 24, 2016

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14001A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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