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 ).