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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294057
• Other study ID #: HI16C0455-2
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 30, 2019
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Bone Diseases, Metabolic
• Chronic Disease
• Chronic Respiratory Disease
• Osteopenia
• Osteoporosis
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Behavioral:
• Tele-coaching programs
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
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
A Take-home book about chronic disease are provided for self-education

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Seoul National University Hospital	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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Improvement of depression (PHQ-9)	Baseline, 3 months post-intervention
Secondary	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.	Baseline, 3 months post-intervention
Secondary	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).	Baseline, 3 months post-intervention
Secondary	Quality of life (Mcgill QoL)	Improvement of quality of life (Mcgill QoL)	Baseline, 3 months post-intervention
Secondary	Quality of life (EuroQoL)	Improvement of quality of life (EuroQoL)	Baseline, 3 months post-intervention
Secondary	Quality of life (SF-12)	Improvement of quality of life (SF-12)	Baseline, 3 months post-intervention
Secondary	Physical activity	Changes in exercise (Godin's Leisure Time Exercise Questionnaire)	Baseline, 3 months post-intervention