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

Primary Purpose

Osteoporosis, Chronic Respiratory Disease, Arthritis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tele-coaching programs
ICT programs
A book about chronic disease
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoporosis focused on measuring Self-Management IT Program

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ICT programs + Tele-coaching programs

ICT programs

A book about chronic disease

Arm Description

ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH) are provided. And a trained nurse provides tele-coaching programs to subjects. After that, subjects will conduct self-management health care and tele-coaching programs for 12 weeks. After 3 months, they finish self-management ICT + coaching programs, and then they fill out the questionnaire.

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.

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.

Outcomes

Primary Outcome Measures

Depression
Improvement of depression (PHQ-9)

Secondary Outcome Measures

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.
Health Management Strategies
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).
Quality of life (Mcgill QoL)
Improvement of quality of life (Mcgill QoL)
Quality of life (EuroQoL)
Improvement of quality of life (EuroQoL)
Quality of life (SF-12)
Improvement of quality of life (SF-12)
Physical activity
Changes in exercise (Godin's Leisure Time Exercise Questionnaire)

Full Information

First Posted
September 19, 2017
Last Updated
March 15, 2021
Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03294057
Brief Title
Collaborative Care With Smart Health Management Program for Patients With Chronic Illness
Official Title
The Effectiveness of Collaborative Care With Smart Health Management Program for Patients With Chronic Illness: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Chronic Respiratory Disease, Arthritis, Osteopenia
Keywords
Self-Management IT Program

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICT programs + Tele-coaching programs
Arm Type
Experimental
Arm Description
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH) are provided. And a trained nurse provides tele-coaching programs to subjects. After that, subjects will conduct self-management health care and tele-coaching programs for 12 weeks. After 3 months, they finish self-management ICT + coaching programs, and then they fill out the questionnaire.
Arm Title
ICT programs
Arm Type
Experimental
Arm Description
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.
Arm Title
A book about chronic disease
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tele-coaching programs
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ICT programs
Intervention Description
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)
Intervention Type
Behavioral
Intervention Name(s)
A book about chronic disease
Intervention Description
A Take-home book about chronic disease are provided for self-education
Primary Outcome Measure Information:
Title
Depression
Description
Improvement of depression (PHQ-9)
Time Frame
Baseline, 3 months post-intervention
Secondary Outcome Measure Information:
Title
Health behavior patterns
Description
We identify health habits by dividing into five steps according to the TTM stage. We evaluate Increase in maintenance rate of health behavior patterns.
Time Frame
Baseline, 3 months post-intervention
Title
Health Management Strategies
Description
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).
Time Frame
Baseline, 3 months post-intervention
Title
Quality of life (Mcgill QoL)
Description
Improvement of quality of life (Mcgill QoL)
Time Frame
Baseline, 3 months post-intervention
Title
Quality of life (EuroQoL)
Description
Improvement of quality of life (EuroQoL)
Time Frame
Baseline, 3 months post-intervention
Title
Quality of life (SF-12)
Description
Improvement of quality of life (SF-12)
Time Frame
Baseline, 3 months post-intervention
Title
Physical activity
Description
Changes in exercise (Godin's Leisure Time Exercise Questionnaire)
Time Frame
Baseline, 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Ho Yun, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33674921
Citation
Kang E, Park SM, Lee K, Lee EB, Yim JJ, Lee J, Kim S, Rhee YE, Yun YH. Efficacy of Health Coaching and an Electronic Health Management Program: Randomized Controlled Trial. J Gen Intern Med. 2021 Sep;36(9):2692-2699. doi: 10.1007/s11606-021-06671-2. Epub 2021 Mar 5.
Results Reference
derived

Learn more about this trial

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

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