Effectiveness of Integrated Care Network

April 20, 2020 updated by: Liang-Kung Chen, National Yang Ming University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
398

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
baseline, 3, 6, 9, 12 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
baseline, 3, 6, 9, 12 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month
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
baseline, 6,12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Liang-Kung Chen, MD.PhD., Aging and Health Research Center, National Yang Ming University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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