The Effectiveness of Smart Health Management Program for Patients With Chronic Illness

NCT ID: NCT03294044

Last Updated: 2018-10-24

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2018-07-31

Brief Summary

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This study verifies efficacy of 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 (hypertension, diabetes and dyslipidemia) 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. However, standard Chronic Care Model (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 clinical indicators in patients with hypertension, diabetes and hyperlipidemia.

Participants in this study will respond a baseline questionnaire about health habits, health behavior patterns and quality of life, diet, exercise, etc. After that, participants will be allocated randomly into the intervention group and the control group. The intervention group will receive self-management and educational program with ICT ("S Healthing") while the control group will receive basic educational material with same contents on the disease. "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 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, post-intervention) and clinical outcomes will be compiled and be compared with each other.

Conditions

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Hypertension Dyslipidemias Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

No masking

Study Groups

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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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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 (hypertension, diabetes, dyslipidemia)
* Subject with more than one Poor Disease Control Indicator

1. HbA1C 7.0% or more
2. Systolic BP 140mmHg or more
3. LDL-cholesterol 130mg/dL or more
* 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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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

Korea Health Industry Development Institute

OTHER_GOV

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

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Yun YH, Kang E, Cho YM, Park SM, Kim YJ, Lee HY, Kim KH, Lee K, Koo HY, Kim S, Rhee Y, Lee J, Min JH, Sim JA. Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial. J Med Internet Res. 2020 Jan 22;22(1):e15057. doi: 10.2196/15057.

Reference Type DERIVED
PMID: 32012053 (View on PubMed)

Other Identifiers

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HI16C0455-1

Identifier Type: -

Identifier Source: org_study_id

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