Clinical trial NCT03528005: Effectiveness of Integrated Care Network
Official title: Effectiveness of Integrated Care Network for Community-living Older Adults: a Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fragility
Multimorbidity
Keywords: Integrated Health Care Systems
Multimorbid
Multi-domain intervention
Clinical Trials, Randomized
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 398
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes from baseline life quality at 3, 6, 9, 12 month
timeFrame: baseline, 3, 6, 9, 12 month
Secondary outcomes:
measure: Changes from baseline standard set of health outcome measures for older persons at 3, 6, 9, 12 month
timeFrame: baseline, 3, 6, 9, 12 month
Other outcomes:
measure: Changes from baseline high sensitive C-Reactive Protein in mg/dl at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline total cholesterol in mg/dl at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline triglycerides in mg/dl at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline HDL-C in mg/dl at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline LDL-C in mg/dl at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline fasting glucose in mg/dl at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline HbA1c in % at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline insulin in mIU/L at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline uric acid in mg/dl at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline body mass index in kg/m^2 at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline albumin in g/dl at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline Vitamin D in ng/ml at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month
timeFrame: baseline, 6,12 month
measure: Changes from baseline homocysteine in micromol/l at sixth and twelfth month
timeFrame: baseline, 6,12 month
Locations:
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
city: New Taipei City
country: Taiwan
facility: Shulin Primary Care center
city: New Taipei City
country: Taiwan
facility: Yingge Primary Health Care center
city: New Taipei City
country: Taiwan
facility: Cheng's primary care clinic
city: Yilan
country: Taiwan
facility: National Yang-Ming University Hospital
city: Yilan
country: Taiwan
facility: Taipei Veterans General Hospital Yuanshan Branch
Study officials:
affiliation: Aging and Health Research Center, National Yang Ming University
name: Liang-Kung Chen, MD.PhD.
role: STUDY_DIRECTOR
References:
citation: 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.