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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294044
• Other study ID #: HI16C0455-1
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 31, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus
• Dyslipidemias
• Hypertension

Intervention

Behavioral:
• ICT programs
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).
• A book about chronic disease
A Take-home book about chronic disease are provided for self-education

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea Health Industry Development Institute, National Clinical Research Coordination Center, Seoul, Korea, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success in clinical outcomes of Hypertension from baseline to 3 months	Change in Systolic blood pressure(mmHg)	Baseline, 3 months post-intervention
Primary	Success in clinical outcomes of Dyslipidemia from baseline to 3 months	Change in LDL Cholesterol (mg/dL)	Baseline, 3 months post-intervention
Primary	Success in clinical outcomes of primary disease Diabetes from baseline to 3 months	Change in HbA1c (%)	Baseline, 3 months post-intervention
Secondary	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
Secondary	Depression	Change in depression score (PHQ-9)	Baseline, 3 months post-intervention
Secondary	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
Secondary	Quality of life (SF-12)	Improvement of quality of life (SF-12)	Baseline, 3 months post-intervention
Secondary	Quality of life (Mcgill QOL)	Improvement of quality of life (Mcgill QOL)	Baseline, 3 months post-intervention
Secondary	Quality of life (Euro-QoL)	Improvement of quality of life (Euro-QoL)	Baseline, 3 months post-intervention