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Taiwan Health Promotion Intervention Study for Elders (THISCE)

Primary Purpose

Frail Elderly Syndrome, Cognitive Impairment, Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multidomain intervention
Active control
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frail Elderly Syndrome

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Prefrail or frail community-dwelling people

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    active control

    multidomain intervention

    Arm Description

    Health promotion provided by local health bureau.

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

    Outcomes

    Primary Outcome Measures

    Change from baseline frailty score at 12 months
    Measured by Cardiovascular Health Study(CHS) definition

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2017
    Last Updated
    February 14, 2017
    Sponsor
    Taipei Veterans General Hospital, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03056768
    Brief Title
    Taiwan Health Promotion Intervention Study for Elders
    Acronym
    THISCE
    Official Title
    Taiwan Health Promotion Intervention Study for Elders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 30, 2014 (Actual)
    Primary Completion Date
    October 5, 2015 (Actual)
    Study Completion Date
    July 24, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Veterans General Hospital, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frail Elderly Syndrome, Cognitive Impairment, Cognitive Decline

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    1080 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    active control
    Arm Type
    Active Comparator
    Arm Description
    Health promotion provided by local health bureau.
    Arm Title
    multidomain intervention
    Arm Type
    Experimental
    Arm Description
    1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multidomain intervention
    Intervention Description
    1-year multidomain health promotion (physical, cognitive, nutritional intervention)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active control
    Intervention Description
    Health promotion activities provided by local health bureau.
    Primary Outcome Measure Information:
    Title
    Change from baseline frailty score at 12 months
    Description
    Measured by Cardiovascular Health Study(CHS) definition
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Prefrail or frail community-dwelling people Exclusion Criteria: Institutionalized or ADL dependent Diagnosed dementia Limited life expectancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liang-Kung Chen, MD, PhD
    Organizational Affiliation
    Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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