Clinical trial NCT03294057: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Chronic Respiratory Disease
Arthritis
Osteopenia
Keywords: Self-Management IT Program
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
name: National Evidence-Based Healthcare Collaborating Agency
name: National Institute of Health, Korea
name: National Clinical Research Coordination Center, Seoul, Korea
name: Seoul National University Bundang Hospital
First posted: 2017-09-26
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Depression
timeFrame: Baseline, 3 months post-intervention
Secondary outcomes:
measure: Health behavior patterns
timeFrame: Baseline, 3 months post-intervention
measure: Health Management Strategies
timeFrame: Baseline, 3 months post-intervention
measure: Quality of life (Mcgill QoL)
timeFrame: Baseline, 3 months post-intervention
measure: Quality of life (EuroQoL)
timeFrame: Baseline, 3 months post-intervention
measure: Quality of life (SF-12)
timeFrame: Baseline, 3 months post-intervention
measure: Physical activity
timeFrame: Baseline, 3 months post-intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Ho Yun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.