Effectiveness of Integrated Care Network

Effectiveness of Integrated Care Network for Community-living Older Adults: a Randomized-Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Multimorbidity; Fragility
• Intervention / Treatment: Behavioral: Multi-domain intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline, 3, 6, 9, 12 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, 6,12 month
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	baseline, 6,12 month
Changes from baseline triglycerides in mg/dl at sixth and twelfth month	Changes from baseline triglycerides in mg/dl at sixth and twelfth month	baseline, 6,12 month
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	baseline, 6,12 month
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	baseline, 6,12 month
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	baseline, 6,12 month
Changes from baseline HbA1c in % at sixth and twelfth month	Changes from baseline Hemoglobin A1c in % at sixth and twelfth month	baseline, 6,12 month
Changes from baseline insulin in mIU/L at sixth and twelfth month	Changes from baseline insulin in mIU/L at sixth and twelfth month	baseline, 6,12 month
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	baseline, 6,12 month
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	baseline, 6,12 month
Changes from baseline albumin in g/dl at sixth and twelfth month	Changes from baseline albumin in g/dl at sixth and twelfth month	baseline, 6,12 month
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	baseline, 6,12 month
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	baseline, 6,12 month
Changes from baseline homocysteine in micromol/l at sixth and twelfth month	Changes from baseline homocysteine in micromol/l at sixth and twelfth month	baseline, 6,12 month

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Study Director: Liang-Kung Chen, MD.PhD., Aging and Health Research Center, National Yang Ming University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): March 14, 2020
• Study Completion (Actual): March 14, 2020

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 5, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Integrated Health Care Systems; Multimorbid; Multi-domain intervention; Clinical Trials, Randomized
• Other Study ID Numbers: YM107042F

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No