Clinical trial NCT03294044: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Dyslipidemias
Diabetes Mellitus
Keywords: Self-Management IT Program
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Evidence-Based Healthcare Collaborating Agency
name: National Institute of Health, Korea
name: National Clinical Research Coordination Center, Seoul, Korea
name: Korea Health Industry Development Institute
First posted: 2017-09-26
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

  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)

Primary outcomes:
measure: Success in clinical outcomes of Hypertension from baseline to 3 months
timeFrame: Baseline, 3 months post-intervention
measure: Success in clinical outcomes of Dyslipidemia from baseline to 3 months
timeFrame: Baseline, 3 months post-intervention
measure: Success in clinical outcomes of primary disease Diabetes from baseline to 3 months
timeFrame: Baseline, 3 months post-intervention
Secondary outcomes:
measure: Health behavior patterns
timeFrame: Baseline, 3 months post-intervention
measure: Depression
timeFrame: Baseline, 3 months post-intervention
measure: Health Management Strategies
timeFrame: Baseline, 3 months post-intervention
measure: Quality of life (SF-12)
timeFrame: Baseline, 3 months post-intervention
measure: Quality of life (Mcgill QOL)
timeFrame: Baseline, 3 months post-intervention
measure: Quality of life (Euro-QoL)
timeFrame: Baseline, 3 months post-intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
affiliation: Seoul National University Hospital
name: Young Ho Yun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.