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

Study Overview
=================
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.

Official Title
-----------------
The Effectiveness of Smart Health Management Program With Proactive Overcoming for Patients With Chronic Illness: Randomized Controlled Trial

Conditions
-----------------
Hypertension, Dyslipidemias, Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: ICT programs
* Behavioral: A book about chronic disease


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICT programs<br>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<br>* ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).<br>|
| Active Comparator: A book about chronic disease<br>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<br>* A Take-home book about chronic disease are provided for self-education<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in clinical outcomes of Hypertension from baseline to 3 months | Change in Systolic blood pressure(mmHg) | Baseline, 3 months post-intervention | 
| Success in clinical outcomes of Dyslipidemia from baseline to 3 months | Change in LDL Cholesterol (mg/dL) | Baseline, 3 months post-intervention | 
| Success in clinical outcomes of primary disease Diabetes from baseline to 3 months | Change in HbA1c (%) | Baseline, 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 3 months post-intervention | 
| Depression | Change in depression score (PHQ-9) | Baseline, 3 months post-intervention | 
| 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. | Baseline, 3 months post-intervention | 
| Quality of life (SF-12) | Improvement of quality of life (SF-12) | Baseline, 3 months post-intervention | 
| Quality of life (Mcgill QOL) | Improvement of quality of life (Mcgill QOL) | Baseline, 3 months post-intervention | 
| Quality of life (Euro-QoL) | Improvement of quality of life (Euro-QoL) | Baseline, 3 months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self-Management IT Program