- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056768
Taiwan Health Promotion Intervention Study for Elders (THISCE)
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
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Prefrail or frail community-dwelling people
Exclusion Criteria:
- Institutionalized or ADL dependent
- Diagnosed dementia
- Limited life expectancy
Study Plan
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.
|
Health promotion activities provided by local health bureau.
|
Experimental: multidomain intervention
1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions)
|
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
Investigators
- Principal Investigator: Liang-Kung Chen, MD, PhD, Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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