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Completed

NCT Number: NCT03294044

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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)

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)

Treatment and study plan

ICT programs

Behavioral

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

Behavioral

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

Primary outcomes

  1. Success in clinical outcomes of Hypertension from baseline to 3 months

    Time frame: Baseline, 3 months post-intervention

    Change in Systolic blood pressure(mmHg)

  2. Success in clinical outcomes of Dyslipidemia from baseline to 3 months

    Time frame: Baseline, 3 months post-intervention

    Change in LDL Cholesterol (mg/dL)

  3. Success in clinical outcomes of primary disease Diabetes from baseline to 3 months

    Time frame: Baseline, 3 months post-intervention

    Change in HbA1c (%)

Secondary outcomes

  1. Health behavior patterns

    Time frame: Baseline, 3 months post-intervention

    We identify health habits by dividing into five steps according to the TTM stage. We evaluate increase in maintenance rate of health behavior patterns.

  2. Depression

    Time frame: Baseline, 3 months post-intervention

    Change in depression score (PHQ-9)

  3. Health Management Strategies

    Time frame: Baseline, 3 months post-intervention

    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.

  4. Quality of life (SF-12)

    Time frame: Baseline, 3 months post-intervention

    Improvement of quality of life (SF-12)

  5. Quality of life (Mcgill QOL)

    Time frame: Baseline, 3 months post-intervention

    Improvement of quality of life (Mcgill QOL)

  6. Quality of life (Euro-QoL)

    Time frame: Baseline, 3 months post-intervention

    Improvement of quality of life (Euro-QoL)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2017
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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