Skip to main content
OpenTrials
Completed

NCT Number: NCT03294057

Collaborative Care With Smart Health Management Program for Patients With Chronic Illness

This study verifies efficacy of collaborative care with 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

This study is to demonstrate that chronic disease patients receiving collaborative care 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. The collaborative care management based Chronic Care Model (CCM) have provided coaching by a medically supervised nurse, working with each patient's physician. However, standard 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 depression in patients with osteoporosis, chronic respiratory disease and chronic arthritis.

Participants in this study will respond a baseline questionnaire about depressive mood, health habits, health behavior patterns and quality of life, diet, exercise, etc. After that, participants will be allocated equally into three groups - the intervention group 1, intervention group 2 and the control group. The intervention group 1 will receive S Healthing and a tele- coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. The intervention group 2 will receive S Healthing while the control group will receive basic educational material on the disease. Coaching content consists specifically of: 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice. "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 1, 2 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, 3 months post-intervention) and clinical outcome of baseline and 3 months will be compiled and be compared with others.

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 (osteoporosis, chronic pulmonary disease, chronic arthritis)
  • Subject with METs less than 12.5 hours per week
  • 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

Tele-coaching programs

Behavioral

Tele-coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. Coaching content specifically, 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice.

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. Depression

    Time frame: Baseline, 3 months post-intervention

    Improvement of depression (PHQ-9)

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. Health Management Strategies

    Time frame: Baseline, 3 months post-intervention

    Improvement of Health Management Strategies by SAT (We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves).

  3. Quality of life (Mcgill QoL)

    Time frame: Baseline, 3 months post-intervention

    Improvement of quality of life (Mcgill QoL)

  4. Quality of life (EuroQoL)

    Time frame: Baseline, 3 months post-intervention

    Improvement of quality of life (EuroQoL)

  5. Quality of life (SF-12)

    Time frame: Baseline, 3 months post-intervention

    Improvement of quality of life (SF-12)

  6. Physical activity

    Time frame: Baseline, 3 months post-intervention

    Changes in exercise (Godin's Leisure Time Exercise Questionnaire)

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
  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 26, 2017
Registry last updated
Mar 17, 2021

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.

Published trials that share one or more normalized conditions with this study.