HypertensionNCT03294044
The Effectiveness of Smart Health Management Program for Patients With Chronic Illness
A study testing ICT programs and A book about chronic disease in people with Hypertension and Dyslipidemias, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study verifies efficacy of 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 more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Dyslipidemias, Diabetes Mellitus
- What is being tested?
- 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
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 2017to 31 Jul 2018
- 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 (hypertension, diabetes, dyslipidemia)
- Subject with more than one Poor Disease Control Indicator
- HbA1C 7.0% or more
- Systolic BP 140mmHg or more
- LDL-cholesterol 130mg/dL or more
- 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 Smart Health Management Program With Proactive Overcoming for Patients With Chronic Illness: Randomized Controlled Trial
This study verifies efficacy of 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 (hypertension, diabetes and dyslipidemia) 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. However, standard Chronic Care Model (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 clinical indicators in patients with hypertension, diabetes and hyperlipidemia.
Participants in this study will respond a baseline questionnaire about health habits, health behavior patterns and quality of life, diet, exercise, etc. After that, participants will be allocated randomly into the intervention group and the control group. The intervention group will receive self-management and educational program with ICT ("S Healthing") while the control group will receive basic educational material with same contents on the disease. "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 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, post-intervention) and clinical outcomes will be compiled and be compared with each other.
- Conditions
- Hypertension, Dyslipidemias, Diabetes Mellitus
- Being tested
- ICT programs, A book about chronic disease
- Keywords
- Self-Management IT Program
- Medical subject headings
- Hypertension, Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | 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.
Success in clinical outcomes of Hypertension from baseline to 3 months
Change in Systolic blood pressure(mmHg)
Measured: Baseline, 3 months post-intervention
Success in clinical outcomes of Dyslipidemia from baseline to 3 months
Change in LDL Cholesterol (mg/dL)
Measured: Baseline, 3 months post-intervention
Success in clinical outcomes of primary disease Diabetes from baseline to 3 months
Change in HbA1c (%)
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
Depression
Change in depression score (PHQ-9)
Measured: Baseline, 3 months post-intervention
Health Management Strategies
We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves. We evaluate improvement of Health Management Strategies.
Measured: Baseline, 3 months post-intervention
Quality of life (SF-12)
Improvement of quality of life (SF-12)
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 (Euro-QoL)
Improvement of quality of life (Euro-QoL)
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 completion26 Mar 2018
- Study completion31 Jul 2018
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 HypertensionStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Korea Health Industry Development Institute
- 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
- NCT03294044
- Sponsor's protocol ID
- HI16C0455-1
- Status last verified
- Oct 2018
- First submitted
- 19 Sep 2017
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yun YH, Kang E, Cho YM, Park SM, Kim YJ, Lee HY, Kim KH, Lee K, Koo HY, Kim S, Rhee Y, Lee J, Min JH, Sim JA. Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial. J Med Internet Res. 2020 Jan 22;22(1):e15057. doi: 10.2196/15057.
PubMed 32012053
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Smart Health Management Program With Proactive Overcoming for Patients With Chronic Illness: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03294044
- Acronym / sponsor ID
- HI16C0455-1
- Conditions
- Hypertension, Dyslipidemias, Diabetes Mellitus
- Keywords
- Self-Management IT Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Korea Health Industry Development Institute
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 31 Jul 2018 (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 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 (hypertension, diabetes and dyslipidemia) 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. However, standard Chronic Care Model (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 clinical indicators in patients with hypertension, diabetes and hyperlipidemia.
Participants in this study will respond a baseline questionnaire about health habits, health behavior patterns and quality of life, diet, exercise, etc. After that, participants will be allocated randomly into the intervention group and the control group. The intervention group will receive self-management and educational program with ICT ("S Healthing") while the control group will receive basic educational material with same contents on the disease. "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 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, post-intervention) and clinical outcomes will be compiled and be compared with each other.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| 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 (8 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 (hypertension, diabetes, dyslipidemia)
- Subject with more than one Poor Disease Control Indicator
- 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 |
|---|---|---|
| ICT programsICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH). | Behavioural | ICT 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
Success in clinical outcomes of Hypertension from baseline to 3 months
Time frame: Baseline, 3 months post-intervention
Change in Systolic blood pressure(mmHg)
Success in clinical outcomes of Dyslipidemia from baseline to 3 months
Time frame: Baseline, 3 months post-intervention
Change in LDL Cholesterol (mg/dL)
Success in clinical outcomes of primary disease Diabetes from baseline to 3 months
Time frame: Baseline, 3 months post-intervention
Change in HbA1c (%)
6 secondary outcomes
Health behavior patterns
Time frame: Baseline, 3 months post-intervention
Depression
Time frame: Baseline, 3 months post-intervention
Health Management Strategies
Time frame: Baseline, 3 months post-intervention
Quality of life (SF-12)
Time frame: Baseline, 3 months post-intervention
Quality of life (Mcgill QOL)
Time frame: Baseline, 3 months post-intervention
Quality of life (Euro-QoL)
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 24 Oct 2018.
- Derived from this study: PubMed 32012053Yun YH, Kang E, Cho YM, Park SM, Kim YJ, Lee HY, Kim KH, Lee K, Koo HY, Kim S, Rhee Y, Lee J, Min JH, Sim JA. Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial. J Med Internet Res. 2020 Jan 22;22(1):e15057. doi: 10.2196/15057.
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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 ICT programs and A book about chronic disease in people with Hypertension and Dyslipidemias, 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 8 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 24 Oct 2018. 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?
Success in clinical outcomes of Hypertension from baseline to 3 months (time frame: Baseline, 3 months post-intervention). The study lists 3 primary outcomes in all. 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 NCT03294044, 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 24 Oct 2018.