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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03294057
Enrollment
54
Registered
2017-09-26
Start date
2017-10-27
Completion date
2019-06-30
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Chronic Respiratory Disease, Osteopenia, Osteoporosis

Keywords

Self-Management IT Program

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.

Interventions

BEHAVIORALTele-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.

BEHAVIORALICT programs

ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)

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

Sponsors

Korea Health Industry Development Institute
CollaboratorOTHER_GOV
National Evidence-Based Healthcare Collaborating Agency
CollaboratorOTHER_GOV
National Institute of Health, Korea
CollaboratorOTHER_GOV
National Clinical Research Coordination Center, Seoul, Korea
CollaboratorOTHER_GOV
Seoul National University Bundang Hospital
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
DepressionBaseline, 3 months post-interventionImprovement of depression (PHQ-9)

Secondary

MeasureTime frameDescription
Health Management StrategiesBaseline, 3 months post-interventionImprovement 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)Baseline, 3 months post-interventionImprovement of quality of life (Mcgill QoL)
Health behavior patternsBaseline, 3 months post-interventionWe identify health habits by dividing into five steps according to the TTM stage. We evaluate Increase in maintenance rate of health behavior patterns.
Quality of life (SF-12)Baseline, 3 months post-interventionImprovement of quality of life (SF-12)
Physical activityBaseline, 3 months post-interventionChanges in exercise (Godin's Leisure Time Exercise Questionnaire)
Quality of life (EuroQoL)Baseline, 3 months post-interventionImprovement of quality of life (EuroQoL)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026