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

NCT ID: NCT03294057

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoporosis Chronic Respiratory Disease Arthritis Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tele-coaching programs

Intervention Type BEHAVIORAL

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.

ICT programs

Intervention Type BEHAVIORAL

ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)

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.

Group Type EXPERIMENTAL

ICT programs

Intervention Type BEHAVIORAL

ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)

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.

Group Type ACTIVE_COMPARATOR

A book about chronic disease

Intervention Type BEHAVIORAL

A Take-home book about chronic disease are provided for self-education

Interventions

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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.

Intervention Type BEHAVIORAL

ICT programs

ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)

Intervention Type BEHAVIORAL

A book about chronic disease

A Take-home book about chronic disease are provided for self-education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role collaborator

National Evidence-Based Healthcare Collaborating Agency

OTHER_GOV

Sponsor Role collaborator

National Institute of Health, Korea

OTHER_GOV

Sponsor Role collaborator

National Clinical Research Coordination Center, Seoul, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Ho Yun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Ho Yun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kang E, Park SM, Lee K, Lee EB, Yim JJ, Lee J, Kim S, Rhee YE, Yun YH. Efficacy of Health Coaching and an Electronic Health Management Program: Randomized Controlled Trial. J Gen Intern Med. 2021 Sep;36(9):2692-2699. doi: 10.1007/s11606-021-06671-2. Epub 2021 Mar 5.

Reference Type DERIVED
PMID: 33674921 (View on PubMed)

Other Identifiers

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HI16C0455-2

Identifier Type: -

Identifier Source: org_study_id

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