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CompletedNCT03528005Updated Apr 21, 2020

Effectiveness of Integrated Care Network

An interventional study of Multi-domain intervention in Fragility and Multimorbidity, sponsored by National Yang Ming Chiao Tung University. Completed at 6 sites in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
398
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

Population aging and the progress of medical technology are two main causes for the increase of healthcare expenditure. Effective management of medical expenditure and maintenance of health care quality have become the most important task for the public health and clinical care services. Both United Kingdom and the World Health Organization proposed introducing interdisciplinary team care to improve health of older people and to maximize their independence. Prof Michael Porter has addressed the current difficulty of healthcare system, and proposed that healthcare system should pursuit long-term outcome to promote the value of health care. This project aims to echo the international trends, using Taiwan healthcare system as the basis to establish the community-based integrated care service model, and to use the randomized controlled trial design to validate the clinical effectiveness.

02

Conditions studied

  • Fragility
  • Multimorbidity

Keywords

  • Integrated Health Care Systems
  • Multimorbid
  • Multi-domain intervention
  • Clinical Trials, Randomized
03

In context

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
398 participants (actual)

Study arms

  • No intervention
    Control

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

  • Experimental
    Intervention

    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

  • BehavioralMulti-domain intervention

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

06

What researchers measure

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).

    Time frame: 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

    a standard health care set proposed by the International Consortium for Health Outcomes Measurement (ICHOM)

    Time frame: baseline, 3, 6, 9, 12 month

Other outcomes

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

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

    Time frame: baseline, 6,12 month

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

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

    Time frame: baseline, 6,12 month

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

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

    Time frame: baseline, 6,12 month

  4. Changes from baseline HDL-C in mg/dl at sixth and twelfth month

    Changes from baseline High-density lipoproteins (HDL) in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

  5. Changes from baseline LDL-C in mg/dl at sixth and twelfth month

    Changes from baseline Low-density lipoproteins (LDL) in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

  6. Changes from baseline fasting glucose in mg/dl at sixth and twelfth month

    Changes from baseline fasting glucose in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

  7. Changes from baseline HbA1c in % at sixth and twelfth month

    Changes from baseline Hemoglobin A1c in % at sixth and twelfth month

    Time frame: baseline, 6,12 month

  8. Changes from baseline insulin in mIU/L at sixth and twelfth month

    Changes from baseline insulin in mIU/L at sixth and twelfth month

    Time frame: baseline, 6,12 month

  9. Changes from baseline uric acid in mg/dl at sixth and twelfth month

    Changes from baseline uric acid in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

  10. Changes from baseline body mass index in kg/m^2 at sixth and twelfth month

    Changes from baseline body mass index in kg/m\^2 at sixth and twelfth month

    Time frame: baseline, 6,12 month

  11. Changes from baseline albumin in g/dl at sixth and twelfth month

    Changes from baseline albumin in g/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

  12. Changes from baseline Vitamin D in ng/ml at sixth and twelfth month

    Changes from baseline Vitamin D in ng/ml at sixth and twelfth month

    Time frame: baseline, 6,12 month

  13. Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month

    Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month

    Time frame: baseline, 6,12 month

  14. Changes from baseline homocysteine in micromol/l at sixth and twelfth month

    Changes from baseline homocysteine in micromol/l at sixth and twelfth month

    Time frame: baseline, 6,12 month

07

Study locations

6 sites
  • Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
    Hualien City, 970, Taiwan
  • Shulin Primary Care center
    New Taipei City, 238, Taiwan
  • Yingge Primary Health Care center
    New Taipei City, 239, Taiwan
  • Cheng's primary care clinic
    New Taipei City, 241, Taiwan
  • National Yang-Ming University Hospital
    Yilan, 264, Taiwan
  • Taipei Veterans General Hospital Yuanshan Branch
    Yilan, 264, Taiwan
08

References and documents

Publications

  • 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. PubMed 36098028 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03528005
Lead sponsor
National Yang Ming Chiao Tung University
Responsible party
Liang-Kung Chen (Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
May 17, 2018
Start date
Jun 25, 2018
Primary completion
Mar 14, 2020
Completion
Mar 14, 2020
Last update
Apr 21, 2020

Study contacts

Liang-Kung Chen, MD.PhD.
study director · Aging and Health Research Center, National Yang Ming University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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