OsteoporosisNCT03294057
Collaborative Care With Smart Health Management Program for Patients With Chronic Illness
A study testing Tele-coaching programs, ICT programs and A book about chronic disease in people with Osteoporosis and Chronic Respiratory Disease, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoporosis, Chronic Respiratory Disease, Arthritis
- What is being tested?
- Tele-coaching programs, ICT programs and A book about chronic disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Collaborative Care With Smart Health Management Program for Patients With Chronic Illness: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoporosis, Chronic Respiratory Disease, Arthritis, Osteopenia
- Being tested
- Tele-coaching programs, ICT programs, A book about chronic disease
- Keywords
- Self-Management IT Program
- Medical subject headings
- Osteoporosis, Arthritis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-coaching programsBehavioural
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 programsBehavioural
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)
A book about chronic diseaseBehavioural
A Take-home book about chronic disease are provided for self-education
| Study group | Role | What they receive |
|---|---|---|
| ICT programs + Tele-coaching programs | Experimental | 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. Receives: Behavioral: Tele-coaching programs; Behavioral: ICT programs |
| ICT programs | Experimental | 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. Receives: Behavioral: ICT programs |
| A book about chronic disease | Active comparator | 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. Receives: Behavioral: A book about chronic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Improvement of depression (PHQ-9)
Measured: Baseline, 3 months post-intervention
Secondary outcomes (6)
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.
Measured: Baseline, 3 months post-intervention
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).
Measured: Baseline, 3 months post-intervention
Quality of life (Mcgill QoL)
Improvement of quality of life (Mcgill QoL)
Measured: Baseline, 3 months post-intervention
Quality of life (EuroQoL)
Improvement of quality of life (EuroQoL)
Measured: Baseline, 3 months post-intervention
Quality of life (SF-12)
Improvement of quality of life (SF-12)
Measured: Baseline, 3 months post-intervention
Physical activity
Changes in exercise (Godin's Leisure Time Exercise Questionnaire)
Measured: Baseline, 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start27 Oct 2017
- Primary completion7 Jun 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Young Ho Yun, Seoul National University Hospital
- Investigators
- Young Ho Yun, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294057
- Sponsor's protocol ID
- HI16C0455-2
- Status last verified
- Mar 2021
- First submitted
- 19 Sep 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33674921
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Collaborative Care With Smart Health Management Program for Patients With Chronic Illness: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03294057
- Acronym / sponsor ID
- HI16C0455-2
- Conditions
- Osteoporosis, Chronic Respiratory Disease, Arthritis, Osteopenia
- Keywords
- Self-Management IT Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- 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
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| ICT programs + Tele-coaching programs | Experimental | Behavioral: Tele-coaching programs, Behavioral: ICT programsICT 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 | Experimental | Behavioral: ICT programsICT 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. |
| A book about chronic disease | Active comparator | Behavioral: A book about chronic diseaseSubjects in the group get a book about chronic disease for patients. After 3 months, they finish reading the materials, they fill out the questionnaire. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-coaching programsTele-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. | Behavioural | ICT programs + Tele-coaching programs |
| ICT programsICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH) | Behavioural | ICT programs, ICT programs + Tele-coaching programs |
| A book about chronic diseaseA Take-home book about chronic disease are provided for self-education | Behavioural | A book about chronic disease |
Primary outcome
Depression
Time frame: Baseline, 3 months post-intervention
Improvement of depression (PHQ-9)
6 secondary outcomes
Health behavior patterns
Time frame: Baseline, 3 months post-intervention
Health Management Strategies
Time frame: Baseline, 3 months post-intervention
Quality of life (Mcgill QoL)
Time frame: Baseline, 3 months post-intervention
Quality of life (EuroQoL)
Time frame: Baseline, 3 months post-intervention
Quality of life (SF-12)
Time frame: Baseline, 3 months post-intervention
Physical activity
Time frame: Baseline, 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 33674921Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Ho Yun, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-coaching programs, ICT programs and A book about chronic disease in people with Osteoporosis and Chronic Respiratory Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Baseline, 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.