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

Seoul National University

Status: Completed

Conditions: Hypertension; Dyslipidemias; Diabetes Mellitus

Treatments: Behavioral: ICT programs; Behavioral: A book about chronic disease

Study type: Interventional

Funder types: Other

Identifiers

NCT03294044

HI16C0455-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

ICT programs

Experimental group

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.

Treatment:

Behavioral: ICT programs

A book about chronic disease

Active Comparator group

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.

Treatment:

Behavioral: A book about chronic disease