NCT03528005

Brief Summary

This project aims to examine the effectiveness of the community-based integrated care service model , based on a multi-domain intervention program, among community-dwelling older adults. Moreover, the investigators use the value-based healthcare standard set as well as comprehensive geriatric assessment as outcome measures and to use the randomized controlled trial design to validate the clinical effectiveness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

April 24, 2018

Last Update Submit

April 20, 2020

Conditions

FragilityMultimorbidity

Keywords

Integrated Health Care SystemsMultimorbidMulti-domain interventionClinical Trials, Randomized

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline life quality at 3, 6, 9, 12 month

    measured by the 36-Item Short Form Health Survey (SF-36).

    baseline, 3, 6, 9, 12 month

Secondary Outcomes (1)

  • Changes from baseline standard set of health outcome measures for older persons at 3, 6, 9, 12 month

    baseline, 3, 6, 9, 12 month

Other Outcomes (14)

  • Changes from baseline high sensitive C-Reactive Protein in mg/dl at sixth and twelfth month

    baseline, 6,12 month

  • Changes from baseline total cholesterol in mg/dl at sixth and twelfth month

    baseline, 6,12 month

  • Changes from baseline triglycerides in mg/dl at sixth and twelfth month

    baseline, 6,12 month

  • +11 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

A regular health education program was provided by case managers only.

Intervention

EXPERIMENTAL

Multi-domain intervention included exercise,cognitive training, diet education, and disease consultation was conducted for two hours twice per week in the first month, once per week in the second month, and once per month since third month.

Behavioral: Multi-domain intervention

Interventions

Multi-domain interventionBEHAVIORAL

60 minutes cognitive training, 45 minutes physical exercise, 15 diet nutrition and intermittent disease management consultation

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age ≧ 65 years
  • three or more chronic conditions, defined by National Health Insurance list of chronic conditions
  • covered by National Health Insurance

You may not qualify if:

  • could not understanding protocol or communication with research nurses
  • malignant diseases under active treatments
  • life expectancy less than twelve months
  • admitted in the long term facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation

Hualien City, 970, Taiwan

Location

Shulin Primary Care center

New Taipei City, 238, Taiwan

Location

Yingge Primary Health Care center

New Taipei City, 239, Taiwan

Location

Cheng's primary care clinic

New Taipei City, 241, Taiwan

Location

National Yang-Ming University Hospital

Yilan, 264, Taiwan

Location

Taipei Veterans General Hospital Yuanshan Branch

Yilan, 264, Taiwan

Location

Related Publications (2)

  • Lee WJ, Peng LN, Lin MH, Kim S, Hsiao FY, Chen LK. Enhancing Intrinsic Capacity and Related Biomarkers in Community-Dwelling Multimorbid Older Adults Through Integrated Multidomain Interventions: Ancillary Findings From the Taiwan Integrated Geriatric (TIGER) Trial. J Am Med Dir Assoc. 2024 May;25(5):757-763.e4. doi: 10.1016/j.jamda.2023.10.006. Epub 2023 Nov 7.

    PMID: 37949432DERIVED

  • Lee WJ, Peng LN, Lin CH, Chen RC, Lin SZ, Loh CH, Kao SL, Hung TS, Chang CY, Huang CF, Tang TC, Huang ST, Wen YW, Hsiao FY, Chen LK; Taiwan Integrated Geriatric Care Study Group. Effects of incorporating multidomain interventions into integrated primary care on quality of life: a randomised controlled trial. Lancet Healthy Longev. 2021 Nov;2(11):e712-e723. doi: 10.1016/S2666-7568(21)00248-8. Epub 2021 Oct 22.

    PMID: 36098028DERIVED

Study Officials

  • Liang-Kung Chen, MD.PhD.

    Aging and Health Research Center, National Yang Ming University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 17, 2018

Study Start

June 25, 2018

Primary Completion

March 14, 2020

Study Completion

March 14, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations

TW(6)