Effectiveness of Integrated Care Network

Multimorbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528005
• Other study ID #: YM107042F
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: March 14, 2020

Study information

• Verified date: April 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: March 14, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fragility
• Multimorbidity

Intervention

Behavioral:
• Multi-domain intervention
60 minutes cognitive training, 45 minutes physical exercise, 15 diet nutrition and intermittent disease management consultation

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation	Hualien City
Taiwan	Cheng's primary care clinic	New Taipei City
Taiwan	Shulin Primary Care center	New Taipei City
Taiwan	Yingge Primary Health Care center	New Taipei City
Taiwan	National Yang-Ming University Hospital	Yilan
Taiwan	Taipei Veterans General Hospital Yuanshan Branch	Yilan

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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