초록

본 연구는 최근 국내에서 지속적으로 증가세를 보이는 관상동맥질환 관련 의료비 상승에 대한 대책으로서, 직접 비용 증가의 주요 원인인 질환의 재발을 막기 위해 건강 이론 기반의 행동수정용 심장 재활 스마트폰 앱을 개발하고 현장 실증 및 그 비용 효과에 대한 검증을 실시함. 본 연구를 통해 심장 재활 및 이차 예방에 효과를 나타내고 의료비 절감에 기여할 것으로 기대됨.

(출처 : 요약서 3p)

Abstract ▼

□ Purpose&Contents
1. Background and Purpose of R & D
Recently, the prevalence and mortality rate of coronary artery disease in Korea and elsewhere is continuously increasing. As a result, coronary intervention and medical costs are rising. In particular, in the case of an intervention in whic

□ Purpose&Contents
1. Background and Purpose of R & D
Recently, the prevalence and mortality rate of coronary artery disease in Korea and elsewhere is continuously increasing. As a result, coronary intervention and medical costs are rising. In particular, in the case of an intervention in which a stent is inserted, cardiac rehabilitation after the discharge and continuous self-management are important, and the mortality rate can be greatly reduced. However, traditional hospital-based cardiac rehabilitation treatments account for less than 10% of the patients due to economic, time and geographic limitations. Therefore, it is recently reported that home-based cardiac rehabilitation is emerging as an alternative to hospital-based cardiac rehabilitation, and may have a similar effect at a lower cost than the existing cardiac rehabilitation. In the case of home-based cardiac rehabilitation, the program is delivered through phone calls, e-mail,video calls, and access to cardiac rehabilitation websites. In recent years,however, the efficiency of mobile smartphones, which are capable of calling,text, voicemail, Internet, and app programs, is getting attention. The purpose of this study is to overcome the limitations of accessibility to existing cardiac rehabilitation by utilizing the portability, mobility and convenience of smartphone with penetration rate exceeding 90% and to improve patient acceptance and satisfaction, And to make it possible. In other words, the research and development of behavior modification and self-management improvement program for the risk factors of patients with coronary artery intervention using mobile app technology were conducted and clinical effects and economic efficiency were demonstrated.

2. Contents of research and development
We developed self-management messages, algorithm for taxonomy and apps for patients undergoing coronary intervention, and conducted clinical trials. In detail, consideration is given to the ability of individuals to utilize health information, development of messages using behavioral change theories,development of mobile apps, and clinical trials to evaluate effectiveness and economics.

□ Results
1. Review of domestic and overseas literature and development of patient classification algorithm
In order to reflect the behavioral change theory for the purpose of providing patient-oriented services, we have established basic principles suitable for this study through domestic and foreign literature review. Based on this, we have developed a classification algorithm for 5 categories (cardiac health,nutrition, exercise, stress, smoking cessation) and three stages of behavior change (preplanning, planning or preparation, behavior or maintenance).

2. Message and content development and verification
Qualitative analysis of disease awareness, disease management, and the use of smartphone apps by conducting two focus group interviews on 8 patients who underwent coronary intervention to develop cardiac rehabilitation messages and contents. Based on the analysis results, a message development guide that reflects the behavior change theory is prepared, and experts in each category develop a message draft. In order to verify the draft of the message, we conducted a peer review and message review workshop centered on the medical staff and produced multimedia materials such as photos and videos for effective communication.

3. Development of mobile apps, clinical trial web, coaching web, etc.
We analyzed the requirements for web development for coaching and clinical trial managers with mobile apps (AnSim apps) that will be used by patients.
Based on this, functional range analysis, menu and information structure design, and screen planning of app and web were performed. In order to improve the completeness of the developed apps and web, we conducted unit tests and integration tests of related researchers, and completed the registration of final prototypes in the app market such as Google Play, and provided technical support for clinical trials.

4. Expert Validity Review and Application
Korean language specialist corrected and modified the self-verified message.
In addition, a total of 458 patients were subjected to an assessment of their understanding, usefulness, and so on, and we revised the category messages that earned a score of less than 3.5 on a 5-point scale. Finally, 472 messages were completed.

5. Preliminary Investigation and EQ-5D-3L Feasibility Study for Development of Economic Performance Evaluation Model
We investigated cost-effectiveness studies using smartphones to develop economic evaluation models. To verify the EQ-5D in the patients with coronary artery disease, the EQ-5D tool and the standard gambling method (SG) were used to analyze the health-related efficacy and compared each measure. As a result, the validity of the EQ-5D tool cannot be verified, and it is decided to carry out the economic evaluation using the result of SG which is the utility tool of direct utility.

6. AnSim apps clinical trial
Patients from Korea University Guro Hospital and Sejong Hospital of Bucheon were recruited to participate in clinical trials. The patients had undergone coronary intervention within the past month and gave voluntary written consent. Clinical trials were conducted in a prospective, multicenter, single-blinded study of 120 patients (60 patients in the intervention group and 60 patients in the control group). The intervention group received one customized cardiac rehabilitation message per day from Monday to Saturday(four messages from full categories and two from vulnerable categories) by algorithm for 24 weeks through the AnSim apps, and updated the behavior change step by monthly questionnaire on the app. Also, once a week, a lifestyle coach delivered a follow-up message to encourage healthy lifestyle and compliance to app use. Follow-up was conducted on Baseline, 6-month, and 9-month through Lab tests and questionnaires for participants in the clinical trial.

7. Self-care enhancement effect of AnSim apps
Based on self-report questionnaires of patients participating in clinical trials, we analyzed the effect of self-care enhancement and the influencing factors. The results showed some significant differences in health information literacy, self-efficacy, social support, physical activity, dietary control, drug compliance, perceived stress level, symptom experience, knowledge of coronary artery disease,

8. Estimation of the risk factor improvement effect of AnSim apps
Baseline characteristics, the first and second endpoints and the achieving rate of guideline levels of risk factors at the 6th and 9th months of the clinical trial were compared between two groups. The comparison of the first and second endpoints according to the frequency of app use and age, message usage in the intervention group, and the comparison of the first and second endpoints according to the use of the health diary among the intervention groups were performed. Although there was no significant difference between the two groups in terms of overall patient satisfaction, there was a significant difference in the top 50% of the patients who had a high level of use of AnSim apps such as message use and health diary use. In the control group, the emergency room visit event occurred twice but not in the intervention group.

9. Economic evaluation of AnSim apps
Cost efficiency analysis and sensitivity analysis are performed for economic evaluation compared to the control group. The results of the analysis showed that the medical cost reduction effect of the intervention group was significant. The cause of the difference in the medical cost difference was the cost of treatment with large difference, the cost of treatment materials, unexpected emergency room visit. The result shows that the cost-saving of medical care per patient is KRW 1,184,178. The OCS analysis of the participating hospitals showed that there was no significant difference in the number of hospital visits, the number of medication days, and the average number of medication compliance between the intervention group and the control group.

10. Application for AnSim app trademark and patent
We have established a trademark right strategy for spreading and commercialization of AnSim apps, and have applied for two patents related to customized algorithm and information delivery method for individual patient.

11. AnSim app commercialization model and proliferation plan establishment
As a commercialization model in the future, we plan to provide patients and private insurers with cardiac rehabilitation solutions. In addition, we plan to spread the digital healthcare platform, register medical devices, and advance into overseas markets.

12. Presentations at the relevant academic societies and dissertation
Several abstracts were presented at the annual academic meeting of Korean Society of Cardiology, Hong Kong Asian Cardiac Rehabilitation Society, etc. In addition, a total of six papers were completed, three were published, and three were submitted.

13. Final data analysis and report preparation
We Collected and analyzed general data such as AnSim app message usage and health diary input from patients participating in clinical trials. As a result, more than 50% of the patients read 76% of the messages without significant changes in the app usage for 24 weeks, but most of the patients did not enter their health life log. Satisfaction survey of AnSim app services and messages showed that more than 60% of patients were positive or very positive. However, some opinions on the improvement of eating habits are somehow negative.

□ Expected Contribution
1. Economic evaluation of ICT-based healthcare intervention technology
The economic evaluation model reviewed in this study is the first case applied to domestic ICT-based healthcare intervention technology and can be used in future medical evaluation studies.

2. Heart rehabilitation alternative technique of cardiovascular center
Based on the results of this study, it is possible to apply Ansim app to 21 cardiac rehabilitation centers nationwide, and then to spread the technology as an alternative or substitution to cardiac rehabilitation treatment to other cardiac care hospitals not equipped with cardiac rehabilitation facilities.

3. Expansion studies into other diseases
In addition to coronary artery disease, it can also extend mobile app technology to other cardiac diseases such as heart failure, peripheral vascular disease, and other chronic diseases that long-term and preventive self-management matter. In addition, it can be used as an extension of research on medical diagnosis support system with high safety and effectiveness, research on artificial intelligence and big data utilizing various personal health information.

(출처 : SUMMARY 7p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 7
• Table of Contents ... 12
• 목차 ... 13
• 1. 연구개발과제의 개요 ... 14
• 1-1. 연구개발 목적 ... 14
• 1-2. 연구개발의 필요성 ... 19
• 1-3. 연구개발 범위 ... 21
• 2. 국내외 기술개발 현황 ... 26
• 3. 연구수행 내용 및 결과 ... 34
• 3-1. 국내외 문헌 리뷰 및 환자 분류 알고리즘 개발 ... 34
• 3-2. 메시지 및 콘텐츠 개발 · 검증 ... 39
• 3-3. App 및 Web 기획 · 개발 ... 62
• 3-4. App 및 Web 테스트 · 검증 ... 66
• 3-5. App 및 Web 수정 · 보완 ... 67
• 3-6. 전문가 타당도 검토 및 적용 ... 68
• 3-7. 경제성 평가 모형 개발을 위한 사전 조사 및 EQ-5D-3L적용 타당성 조사 ... 72
• 3-8. 안심앱 임상시험 대상자 선정 및 등록 ... 79
• 3-9. 안심앱 중재 적용 (임상시험 진행) ... 80
• 3-10. 안심앱의 자가관리 증진효과 · 영향요인 분석 ... 84
• 3-11. 안심앱의 위험인자 개선효과 산출 ... 100
• 3-12. 안심앱의 경제성 평가 ... 109
• 3-13. 안심앱 상표권 및 특허권 출원 · 등록 ... 128
• 3-14. 안심앱 상용화 모델 및 확산 계획 수립 ... 129
• 3-15. 관련 학회 발표 및 논문 작성 ... 134
• 3-16. 최종 보고서 준비 ... 135
• 4. 목표달성도 및 관련분야 기여도 ... 142
• 4-1. 목표달성도 ... 142
• 4-2. 관련분야 기여도 ... 143
• 5. 연구결과의 활용계획 ... 147
• 6. 연구과정에서 수집한 해외과학기술정보 ... 148
• 7. 연구개발성과의 보안등급 ... 150
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 150
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 150
• 10. 연구개발과제의 대표적 연구실적 ... 151
• 11. 기타사항 ... 151
• 12. 참고문헌 ... 152
• 별첨: 실적 증빙자료 ... 155
• 별첨: 증례기록서 및 설문지 ... 176
• 끝페이지 ... 204