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

NCT03294044 | Completed DMC

• 1 other identifier: HI16C0455-1
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Dyslipidemias; Diabetes Mellitus

Keywords

Self-Management IT Program

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Health behavior patterns

  Baseline, 3 months post-intervention

• Depression

  Baseline, 3 months post-intervention

• Health Management Strategies

  Baseline, 3 months post-intervention

• Quality of life (SF-12)

  Baseline, 3 months post-intervention

• Quality of life (Mcgill QOL)

  Baseline, 3 months post-intervention

Study Arms (2)

ICT programs

EXPERIMENTAL

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

A book about chronic disease

ACTIVE COMPARATOR

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

Interventions

ICT programs BEHAVIORAL

ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).

ICT programs

A book about chronic disease BEHAVIORAL

A Take-home book about chronic disease are provided for self-education

A book about chronic disease

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• HbA1C 7.0% or more
• Systolic BP 140mmHg or more
• LDL-cholesterol 130mg/dL or more
• Subjects who use smart phones and PCs (those who can use ICT-based health care programs)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Seoul National University

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32012053 DERIVED

MeSH Terms

Conditions

Hypertension; Dyslipidemias; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Young Ho Yun, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 26, 2017
• Study Start: October 27, 2017
• Primary Completion: March 26, 2018
• Study Completion: July 31, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

KR (1)