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Clinical Trials/NCT03294057
NCT03294057
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country54 target enrollmentOctober 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Seoul National University Hospital
Enrollment
54
Locations
1
Primary Endpoint
Depression
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 27, 2017
End Date
June 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Ho Yun

Principal Investigator

Seoul National University Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Depression

Time Frame: Baseline, 3 months post-intervention

Improvement of depression (PHQ-9)

Secondary Outcomes

  • Physical activity(Baseline, 3 months post-intervention)
  • Health Management Strategies(Baseline, 3 months post-intervention)
  • Quality of life (Mcgill QoL)(Baseline, 3 months post-intervention)
  • Health behavior patterns(Baseline, 3 months post-intervention)
  • Quality of life (EuroQoL)(Baseline, 3 months post-intervention)
  • Quality of life (SF-12)(Baseline, 3 months post-intervention)

Study Sites (1)

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