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Taiwan Health Promotion Intervention Study for Elders (THISCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056768
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

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.


Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Cognitive Impairment Cognitive Decline Behavioral: Multidomain intervention Behavioral: Active control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Taiwan Health Promotion Intervention Study for Elders
Actual Study Start Date : August 30, 2014
Actual Primary Completion Date : October 5, 2015
Actual Study Completion Date : July 24, 2016

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)




Primary Outcome Measures :
  1. Change from baseline frailty score at 12 months [ Time Frame: 12 months ]
    Measured by Cardiovascular Health Study(CHS) definition



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prefrail or frail community-dwelling people

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056768


Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Liang-Kung Chen, MD, PhD Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
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Responsible Party: vghtpe user, Principal investigator, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03056768    
Other Study ID Numbers: 14001A
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders