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Effectiveness of Integrated Care Network

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: NCT03528005
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Liang-Kung Chen, National Yang Ming University

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.

Condition or disease Intervention/treatment Phase
Fragility Multimorbidity Behavioral: Multi-domain intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Integrated Care Network for Community-living Older Adults: a Randomized-Controlled Trial
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : March 14, 2020
Actual Study Completion Date : March 14, 2020

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




Primary Outcome Measures :
  1. Changes from baseline life quality at 3, 6, 9, 12 month [ Time Frame: baseline, 3, 6, 9, 12 month ]
    measured by the 36-Item Short Form Health Survey (SF-36).


Secondary Outcome Measures :
  1. Changes from baseline standard set of health outcome measures for older persons at 3, 6, 9, 12 month [ Time Frame: baseline, 3, 6, 9, 12 month ]
    a standard health care set proposed by the International Consortium for Health Outcomes Measurement (ICHOM)


Other Outcome Measures:
  1. Changes from baseline high sensitive C-Reactive Protein in mg/dl at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline high sensitive C-Reactive Protein in mg/dl at sixth and twelfth month

  2. Changes from baseline total cholesterol in mg/dl at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline total cholesterol in mg/dl at sixth and twelfth month

  3. Changes from baseline triglycerides in mg/dl at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline triglycerides in mg/dl at sixth and twelfth month

  4. Changes from baseline HDL-C in mg/dl at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline High-density lipoproteins (HDL) in mg/dl at sixth and twelfth month

  5. Changes from baseline LDL-C in mg/dl at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline Low-density lipoproteins (LDL) in mg/dl at sixth and twelfth month

  6. Changes from baseline fasting glucose in mg/dl at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline fasting glucose in mg/dl at sixth and twelfth month

  7. Changes from baseline HbA1c in % at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline Hemoglobin A1c in % at sixth and twelfth month

  8. Changes from baseline insulin in mIU/L at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline insulin in mIU/L at sixth and twelfth month

  9. Changes from baseline uric acid in mg/dl at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline uric acid in mg/dl at sixth and twelfth month

  10. Changes from baseline body mass index in kg/m^2 at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline body mass index in kg/m^2 at sixth and twelfth month

  11. Changes from baseline albumin in g/dl at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline albumin in g/dl at sixth and twelfth month

  12. Changes from baseline Vitamin D in ng/ml at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline Vitamin D in ng/ml at sixth and twelfth month

  13. Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month

  14. Changes from baseline homocysteine in micromol/l at sixth and twelfth month [ Time Frame: baseline, 6,12 month ]
    Changes from baseline homocysteine in micromol/l at sixth and twelfth month



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

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): NCT03528005


Locations
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Taiwan
Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan, 970
Shulin Primary Care center
New Taipei City, Taiwan, 238
Yingge Primary Health Care center
New Taipei City, Taiwan, 239
Cheng's primary care clinic
New Taipei City, Taiwan, 241
National Yang-Ming University Hospital
Yilan, Taiwan, 264
Taipei Veterans General Hospital Yuanshan Branch
Yilan, Taiwan, 264
Sponsors and Collaborators
National Yang Ming University
Investigators
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Study Director: Liang-Kung Chen, MD.PhD. Aging and Health Research Center, National Yang Ming University
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Responsible Party: Liang-Kung Chen, Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT03528005    
Other Study ID Numbers: YM107042F
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liang-Kung Chen, National Yang Ming University:
Integrated Health Care Systems
Multimorbid
Multi-domain intervention
Clinical Trials, Randomized