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

Primary Purpose

Hypertension, Dyslipidemias, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ICT programs
A book about chronic disease
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Self-Management IT Program

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICT programs

A book about chronic disease

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Success in clinical outcomes of Hypertension from baseline to 3 months
Change in Systolic blood pressure(mmHg)
Success in clinical outcomes of Dyslipidemia from baseline to 3 months
Change in LDL Cholesterol (mg/dL)
Success in clinical outcomes of primary disease Diabetes from baseline to 3 months
Change in HbA1c (%)

Secondary Outcome Measures

Health behavior patterns
We identify health habits by dividing into five steps according to the TTM stage. We evaluate increase in maintenance rate of health behavior patterns.
Depression
Change in depression score (PHQ-9)
Health Management Strategies
We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves. We evaluate improvement of Health Management Strategies.
Quality of life (SF-12)
Improvement of quality of life (SF-12)
Quality of life (Mcgill QOL)
Improvement of quality of life (Mcgill QOL)
Quality of life (Euro-QoL)
Improvement of quality of life (Euro-QoL)

Full Information

First Posted
September 19, 2017
Last Updated
October 22, 2018
Sponsor
Seoul National University Hospital
Collaborators
National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03294044
Brief Title
The Effectiveness of Smart Health Management Program for Patients With Chronic Illness
Official Title
The Effectiveness of Smart Health Management Program With Proactive Overcoming for Patients With Chronic Illness: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Korea Health Industry Development Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias, Diabetes Mellitus
Keywords
Self-Management IT Program

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICT programs
Arm Type
Experimental
Arm Description
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.
Arm Title
A book about chronic disease
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ICT programs
Intervention Description
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).
Intervention Type
Behavioral
Intervention Name(s)
A book about chronic disease
Intervention Description
A Take-home book about chronic disease are provided for self-education
Primary Outcome Measure Information:
Title
Success in clinical outcomes of Hypertension from baseline to 3 months
Description
Change in Systolic blood pressure(mmHg)
Time Frame
Baseline, 3 months post-intervention
Title
Success in clinical outcomes of Dyslipidemia from baseline to 3 months
Description
Change in LDL Cholesterol (mg/dL)
Time Frame
Baseline, 3 months post-intervention
Title
Success in clinical outcomes of primary disease Diabetes from baseline to 3 months
Description
Change in HbA1c (%)
Time Frame
Baseline, 3 months post-intervention
Secondary Outcome Measure Information:
Title
Health behavior patterns
Description
We identify health habits by dividing into five steps according to the TTM stage. We evaluate increase in maintenance rate of health behavior patterns.
Time Frame
Baseline, 3 months post-intervention
Title
Depression
Description
Change in depression score (PHQ-9)
Time Frame
Baseline, 3 months post-intervention
Title
Health Management Strategies
Description
We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves. We evaluate improvement of Health Management Strategies.
Time Frame
Baseline, 3 months post-intervention
Title
Quality of life (SF-12)
Description
Improvement of quality of life (SF-12)
Time Frame
Baseline, 3 months post-intervention
Title
Quality of life (Mcgill QOL)
Description
Improvement of quality of life (Mcgill QOL)
Time Frame
Baseline, 3 months post-intervention
Title
Quality of life (Euro-QoL)
Description
Improvement of quality of life (Euro-QoL)
Time Frame
Baseline, 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 HbA1C 7.0% or more Systolic BP 140mmHg or more 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Ho Yun, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32012053
Citation
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.
Results Reference
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The Effectiveness of Smart Health Management Program for Patients With Chronic Illness

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