Diabetes Mellitus, Dyslipidemias, Hypertension
Conditions
Keywords
Self-Management IT Program
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.
Interventions
BEHAVIORALICT programs
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).
BEHAVIORALA book about chronic disease
A Take-home book about chronic disease are provided for self-education
Sponsors
National Evidence-Based Healthcare Collaborating Agency
National Institute of Health, Korea
National Clinical Research Coordination Center, Seoul, Korea
Korea Health Industry Development Institute
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
No masking
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success in clinical outcomes of Hypertension from baseline to 3 months | Baseline, 3 months post-intervention | Change in Systolic blood pressure(mmHg) |
| Success in clinical outcomes of Dyslipidemia from baseline to 3 months | Baseline, 3 months post-intervention | Change in LDL Cholesterol (mg/dL) |
| Success in clinical outcomes of primary disease Diabetes from baseline to 3 months | Baseline, 3 months post-intervention | Change in HbA1c (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (SF-12) | Baseline, 3 months post-intervention | Improvement of quality of life (SF-12) |
| Health behavior patterns | Baseline, 3 months post-intervention | We identify health habits by dividing into five steps according to the TTM stage. We evaluate increase in maintenance rate of health behavior patterns. |
| Quality of life (Euro-QoL) | Baseline, 3 months post-intervention | Improvement of quality of life (Euro-QoL) |
| Quality of life (Mcgill QOL) | Baseline, 3 months post-intervention | Improvement of quality of life (Mcgill QOL) |
| Depression | Baseline, 3 months post-intervention | Change in depression score (PHQ-9) |
| Health Management Strategies | Baseline, 3 months post-intervention | 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. |
Countries
South Korea
Outcome results
None listed