The Effectiveness of Smart Health Management Program With Proactive Overcoming for Patients With Chronic Illness: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Success in clinical outcomes of Hypertension from baseline to 3 months
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
No masking
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: ICT programs (Behavioral)
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.
Intervention: A book about chronic disease (Behavioral)
Outcomes
Primary Outcomes
Success in clinical outcomes of Hypertension from baseline to 3 months
Time Frame: Baseline, 3 months post-intervention
Change in Systolic blood pressure(mmHg)
Success in clinical outcomes of Dyslipidemia from baseline to 3 months
Time Frame: Baseline, 3 months post-intervention
Change in LDL Cholesterol (mg/dL)
Success in clinical outcomes of primary disease Diabetes from baseline to 3 months
Time Frame: Baseline, 3 months post-intervention
Change in HbA1c (%)
Secondary Outcomes
- Health behavior patterns(Baseline, 3 months post-intervention)
- Depression(Baseline, 3 months post-intervention)
- Health Management Strategies(Baseline, 3 months post-intervention)
- Quality of life (SF-12)(Baseline, 3 months post-intervention)
- Quality of life (Mcgill QOL)(Baseline, 3 months post-intervention)
- Quality of life (Euro-QoL)(Baseline, 3 months post-intervention)
Investigators
Young Ho Yun
Principal Investigator
Seoul National University Hospital