Collaborative Care With Smart Health Management Program for Patients With Chronic Illness

March 15, 2021 updated by: Young Ho Yun, Seoul National University Hospital

The Effectiveness of Collaborative Care With Smart Health Management Program for Patients With Chronic Illness: Randomized Controlled Trial

This study verifies efficacy of collaborative care with Smart Health Management Program developed for patients with chronic illness. The aim of the study is to observe the changes in clinical indicators, quality of life and health related behaviors when providing self-management programs with ICT for chronic disease patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is to demonstrate that chronic disease patients receiving collaborative care with ICT-based self-management and educational program can improve clinical outcomes and overall health status, including quality of life and health habits.

In addition to the economic burden, people with chronic disease experience various psychosocial crises such as anxiety and depression, which causes the deterioration of overall quality of life and increases social burden. The collaborative care management based Chronic Care Model (CCM) have provided coaching by a medically supervised nurse, working with each patient's physician. However, standard CCM have limitations in that they do not provide self-management strategies of the patient in detail. Therefore, to improve the effectiveness of the CCM model, it is required to propose a new approach to the utilization of IT-based self-management program that is currently being developed to increase accessibility and efficiency of health care service.

Primary outcomes of this study are as follow: Improvement of depression in patients with osteoporosis, chronic respiratory disease and chronic arthritis.

Participants in this study will respond a baseline questionnaire about depressive mood, health habits, health behavior patterns and quality of life, diet, exercise, etc. After that, participants will be allocated equally into three groups - the intervention group 1, intervention group 2 and the control group. The intervention group 1 will receive S Healthing and a tele- coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. The intervention group 2 will receive S Healthing while the control group will receive basic educational material on the disease. Coaching content consists specifically of: 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice. "S Healthing" is based ICT- program and includes educational contents and self-management program based on Smart Management Strategy for Health (SMASH). The intervention group 1, 2 will conduct self-management for 3 months through smart phone application and web program. Participants will receive a questionnaire about the quality of life and health habits with the clinical examination 3 months after baseline survey was conducted. The result from two questionnaires (baseline, 3 months post-intervention) and clinical outcome of baseline and 3 months will be compiled and be compared with others.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • 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

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

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject 19 years old and more
  • Subject who understands the purpose of the study and signs with informed consent form
  • Subject with chronic disease (osteoporosis, chronic pulmonary disease, chronic arthritis)
  • Subject with METs less than 12.5 hours per week
  • Subjects who use smart phones and PCs (those who can use ICT-based health care programs)

Exclusion Criteria:

  • Inability to speak, understand, or write Korean
  • Inability to understand the contents of the provided materials due to poor eyesight and hearing
  • Medical conditions that would limit adherence to participation of the clinical trial (as confirmed by their referring physician; e.g. dyspnea, severe depression and other mental disorders)

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICT programs + Tele-coaching programs
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH) are provided. And a trained nurse provides tele-coaching programs to subjects. After that, subjects will conduct self-management health care and tele-coaching programs for 12 weeks. After 3 months, they finish self-management ICT + coaching programs, and then they fill out the questionnaire.
Behavioral: Tele-coaching programs
Tele-coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. Coaching content specifically, 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice.
Behavioral: ICT programs
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)
Experimental: ICT programs
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH) are provided. After that, subjects will conduct self-management health care for 12 weeks. After 3 months, they finish self-management ICT programs, and then they fill out the questionnaire.
Behavioral: ICT programs
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)
Active Comparator: A book about chronic disease
Subjects in the group get a book about chronic disease for patients. After 3 months, they finish reading the materials, they fill out the questionnaire.
Behavioral: A book about chronic disease
A Take-home book about chronic disease are provided for self-education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Baseline, 3 months post-intervention
Improvement of depression (PHQ-9)
Baseline, 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (SF-12)
Time Frame: Baseline, 3 months post-intervention
Improvement of quality of life (SF-12)
Baseline, 3 months post-intervention
Health behavior patterns
Time Frame: Baseline, 3 months post-intervention
We identify health habits by dividing into five steps according to the TTM stage. We evaluate Increase in maintenance rate of health behavior patterns.
Baseline, 3 months post-intervention
Health Management Strategies
Time Frame: Baseline, 3 months post-intervention
Improvement of Health Management Strategies by SAT (We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves).
Baseline, 3 months post-intervention
Quality of life (Mcgill QoL)
Time Frame: Baseline, 3 months post-intervention
Improvement of quality of life (Mcgill QoL)
Baseline, 3 months post-intervention
Quality of life (EuroQoL)
Time Frame: Baseline, 3 months post-intervention
Improvement of quality of life (EuroQoL)
Baseline, 3 months post-intervention
Physical activity
Time Frame: Baseline, 3 months post-intervention
Changes in exercise (Godin's Leisure Time Exercise Questionnaire)
Baseline, 3 months post-intervention

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital
Korea Health Industry Development Institute
National Evidence-Based Healthcare Collaborating Agency
National Clinical Research Coordination Center, Seoul, Korea
National Institute of Health, Korea

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)

October 27, 2017

Primary Completion (Actual)

June 7, 2018

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HI16C0455-2

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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