Download presentation
Presentation is loading. Please wait.
Published byAugustus Fleming Modified over 6 years ago
1
MyHealthKeeper: Clinical Trial study based on Personal Health Record Healthcare Management
Borim Ryu1,2, Nari Kim1, Eun-Young Heo1, Sooyoung Yoo1 , Se Young Jung1, Yoojung Kim2, Joongsik Lee2 and Jeong-Whun Kim1,2 1 Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, KOREA 2 Seoul National University, Seoul, KOREA Introduction Methods Results & Discussion Clinical trial study results Clinical trial study results A total of 68 participants (44 interventions and 24 controls) completed the study. The PHR intervention group showed significantly higher weight loss than the control group (average: 1.4 kg, 95% confidence interval (CI): ; P<.001) at the final week (week 4). In addition, triglyceride (TG) levels were significantly lower by the end of the study period. (average: 46.7 mg/dL, 95% CI: ; P<.05) Research objective The purpose of this study was to demonstrate the design of a clinical trial to assess the effectiveness of a PHR-based mobile health application given the name MyHealthKeeper, which can help patients with obesity to manage their individual daily routine and improve lifestyle behaviors. Main research topic: Clinical trial study to examine the effectiveness of PHR based clinical intervention using wearable device and mobile user application MyHealthKeeper: PHR application In this study, we aimed to demonstrate the clinician evaluations of PHDs, as well as clinical usability on behalf of personal health record point of view, using wearable devices in lifestyle related disease patients who has obesity. We utilized an activity tracker (Misfit) to collect individual physical activity data and developed a smartphone application to record every meal and daily logs. All participants took a paper-based survey, laboratory test, physical examination, and interview on their opinions. Clinical workflow observations were also processed to monitor and evaluate the study design. Figure 4. Changes in weight, BMI, TG in the two groups Table 1. Baseline clinical profiles of study participants Table 2. Clinical profile changes in participants from each group Characteristics, mean (aSD) Intervention group(N=44) Control group(N=24) P-value Weight (kg) 78.3 (11.8) 82.6 (8.4) 0.126 Height (cm) 168.0(8.7) 174.0 (8.0) 0.012 BMI (kg/m2) 27.6(3.0) 27.3 (2.4) 0.724 Cholesterol (mg/dL) 188.8(32.9) 202.3 (34.6) 0.116 HDL-Cholesterol (mg/dL) 50.6 (8.8) 51.2 (9.9) 0.840 LDL-Cholesterol (mg/dL) 111.5 (24.1) 123.3 (27.9) 0.073 Triglyceride (mg/dL) 152.9 (117.2) 149.5 (68.0) 0.895 Characteristics Pre-intervention (mean±aSD) Post-intervention (mean±aSD) P-value Weight (kg) Intervention group (n=44) 78.3±11.9 76.9±11.2 <0.001 Control group (n=24) 82.5±8.41 82.0±8.3 <0.05 BMI (kg/m2) 27.6±3.0 27.1±2.8 27.2±2.4 27.1±2.4 0.069 Cholesterol (mg/dL) 188.8±32.9 186.7±31.1 0.611 202.3±34.6 203.6±38.9 0.787 HDL-Cholesterol (mg/dL) 50.6±8.8 51.7±9.7 0.203 51.1±12.6 50.3±9.9 0.585 LDL-Cholesterol (mg/dL) 111.5±24.1 112.7±25.4 0.674 123.3±27.9 123.7±28.6 0.918 Triglyceride (mg/dL) 152.9±117.2 106.1±53.9 149.4±68.0 137.8±69.3 0.349 Figure 2. Overall clinical trial process Clinical trial study design We conducted a prospective randomized clinical trial in 80 patients who visited the Seoul National University Bundang Hospital (SNUBH) outpatient clinic between the months of July and September of 2016. We set the following inclusion criteria for enrollment in the trial: 1) Patients who provided prior consent to complying with self-management, 2) Patients without cardiopulmonary disease, cancer, or other acute diseases, and 3) Patients with a body mass index (BMI) of over 23 kg/m2. Enrollees were randomized into two groups: a PHR-based mobile application and clinical intervention group, and a conventional treatment control group. Written informed consent was obtained from all participants. All study participants completed a paper based survey, a laboratory blood test, a physical examination, and an opinion interview. The PHR intervention group received the wearable device, the mobile application software, personal coaching and intervention based on the PHR module to encourage a healthy lifestyle. The participants were educated about lifestyle modifications needed to lose weight, and trained in the use of the Android OS-based smartphone application (designed to collect lifestyle data). Our clinical trial study results revealed a significant change in participant clinical profiles upon PHR-based clinical intervention as guided by the physician. The PHR-intervention group participants who used the MyHealthKeeper mobile application every day and received lifestyle feedback counseling from the clinician showed significantly larger changes in weight, BMI, and triglyceride (TG) values than those in the control group. Summary of conclusion We have developed an innovative testing approach to integrate PHR data into the clinical workflow in order to support lifestyle interventions. The results of this study suggest that PHR-based intervention is successful in preventing weight gain with modest weight loss and improvement in lifestyle behaviors. Lifestyle counseling Lifestyle coaching feedback Acknowledgements This study was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute , funded by the Ministry of Health &Welfare, Republic of Korea (grant number : HI14C3213). This study was also supported by the Creative Industrial Technology Development Program ( , Development of Personalized Healthcare System exploiting User Life-Log and Open Government Data for Business Service Model Proof on Whole Life Cycle Care) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea). Figure 3. PHR based clinical intervention Figure 1. MyHealthKeeper: Mobile application design References Vandelanotte C, Spathonis KM, Eakin EG, Owen N. Website-delivered physical activity interventions a review of the literature. Am J Prev Med 2007 Jul;33(1):54-64. Emani S, Yamin CK, Peters E, Karson AS, Lipsitz SR, Wald JS, et al. Patient perceptions of a personal health record: a test of the diffusion of innovation model. J Med Internet Res. 2012;14(6):e150 This study was approved by the SNUBH Institutional Review Board (B ) and was registered at the United States National Institutes of Health clinical trial registry (ClinicalTrails.gov registration number: NCT ).
Similar presentations
© 2025 SlidePlayer.com. Inc.
All rights reserved.