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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus; Dyslipidemias
• Intervention / Treatment: Behavioral: ICT programs; Behavioral: A book about chronic disease

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: ICT programs; ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).
ACTIVE_COMPARATOR: 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.	Behavioral: A book about chronic disease; A Take-home book about chronic disease are provided for self-education

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Korea Health Industry Development Institute; National Evidence-Based Healthcare Collaborating Agency; National Clinical Research Coordination Center, Seoul, Korea; National Institute of Health, Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2017
• Primary Completion (ACTUAL): March 26, 2018
• Study Completion (ACTUAL): July 31, 2018

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Self-Management IT Program
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Lipid Metabolism Disorders; Dyslipidemias; Chronic Disease
• Other Study ID Numbers: HI16C0455-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No