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Effects of remote lifestyle modification and providing health data to outpatient physicians on coronary risk factors in patients with ischemic heart disease: a multicenter randomized controlled trial

Remote medical support system to improve recurrence risk factors in patie nts with ischemic heart disease

159

A total of 152 participants were analyzed, and 7 participants dropping out before the baseline evaluation. Continuous variables are shown as medians, and categorical variables are shown as frequencies or percentages. Overall, the median age was 59.5 years (58.0 in the intervention group, 61.0 in the control group), and included 137 men (68 intervention group, 69 control group). Acute coronary syndrome was present in 120 participants (59 intervention group, 61 control group), chronic coronary syndrome in 32 (16 in each group). 16 participants (9 intervention group, 7 control group), accounting for approximately 10% of the total cohort, had concomitant heart failure. Coronary risk factors included hypertension in 107 participants (54 intervention group, 53 control group), dyslipidemia in 97 (50 intervention group, 47 control group), diabetes in 44 (23 intervention group, 21 control group), and chronic kidney disease in 13 (7 intervention group, 6 control group). [Baseline data] Body mass index (BMI) was 24.98kg/m2 and 24.63kg/m2 in intervention and control groups, respectively. Morning home blood pressure (systolic / diastolic) was 121.65 / 74.95mmHg and 122.60 / 75.50mmHg in the intervention and control groups, respectively. Biochemical data were as follows: brain natriuretic peptide (BNP), 35.35pg/mL and 47.60pg/mL; N-terminal pro-brain natriuretic peptide (NT-pro BNP), 175.00pg/mL, 134.00 pg/mL; high-density lipoprotein (HLD) cholesterol, 40.80mg/dL and 42.00mg/dL; low-density lipoprotein (LDL) cholesterol, 75.0mg/dL and 76.5mg/dL; fasting triglycerides 109.5mg/dL and 109.0mg/dL; and hemoglobin A1c (HbA1c), 5.90% and 6.05% in the intervention and control groups, respectively. Echocardiographic data showed left ventricular ejection fraction of 56.45% and 57.00% in the intervention and control groups, respectively. The medications prescribed at discharge were beta blockers in 64.0% (48/75) and 64.9% (50/77), angiotensin converting enzyme inhibitors in 25.3% (19/75) and 27.3% (21/77), angiotensin II receptor blocker in 36.0% (27/75) and 31.2% (24/77), mineralocorticoid receptor antagonist in 12.0% (9/75) and 16.9% (13/77), calcium channel blocker in 21.3% (16/75) and 22.1% (17/77), sodium/glucose cotransporter 2 inhibitors in 36.0% (27/75) and 28.6% (22/77), statins in 97.3% (73/75) and 96.1% (74/77), diuretics in 1.3% (1/75) and 5.2% in the intervention and control groups, respectively. The primary and secondary outcome at baseline for the intervention and control groups were as follows: peak oxygen uptake, 19.3 ml/kg/min and 18.75 ml/kg/min; moderate to vigorous physical activity (MVPA), 114 minutes/week and 117 minutes/week; health-related quality of life (QOL) summary scores using the MOS 36-Item Short-Form Health Survey (SF-36), physical component summary (PCS), 49.15 points and 47.25 points; mental component summary (MCS), 51.85 points and 51.55 points; role/social component summary (RCS), 52.90 points and 51.75 points; and mean amplitude of glycemic excursions (MAGE), used as an indicator of blood glucose fluctuation, 55.8 and 62.7.

A total of 159 patients were enrolled in the study and randomized into the intervention group (79 patients) and the control group (80 patients). Of these, 137 patients completed the study through the final assessment as specified in the protocol. Discontinuation occurred in 12 patients in the intervention group and 10 patients in the control group. The reasons for discontinuation included withdrawal by patient request: 5 (3 intervention group, 2 control group), post-enrollment determination of ineligibility: 7 (4 intervention group, 3 control group), inability to continue trial due to patient's circumstances: 8 (5 intervention group, 3 control group), and worsening of complications: 2 (control group).

There were no adverse events.

[Effectiveness] Analysis was performed on 152 patients (75 in the intervention group, 77 in the control group) who underwent baseline evaluation. For patients with missing data at 3 months, the primary outcome was treated as having no increase, and secondary outcome was imputed with baseline data (modified intention-to-treat). Analysis of the target achievement rate for each indicator by group was compared using chi-square test. The change in each indicator by group was compared between baseline and 3 months using Wilcoxon rank sum test. The proportion of participants achieving a >=10% increase in peak oxygen uptake, the primary outcome, was 41.1% (30/73) in the intervention group (95% confidence interval (CI) [29.7%, 53.2%]) and 38.9% (28/72) in the control group (95% CI [27.6%, 51.1%]), with no significant difference between groups (p=0.786). Regarding the proportion of participants achieving a >=6% increase in peak oxygen uptake, the results were 52.1% (38/73) in the intervention group (95% CI [40.0%, 63.9%]) and 52.8% (38/72) in the control group (95% CI [40.7%, 64.7%]), with no significant difference (p=0.931). Analysis of coronary risk factors at 3 months showed the following: the proportion achieving target blood glucose levels (HbA1c) was 90.5% (67/74) in the intervention group (95% CI [81.5%, 96.1%]) and 88.2% (67/76) in the control group (95% CI [78.7%, 94.4%]) (p=0.636); the proportion achieving target lipid levels (LDL cholesterol and triglyceride) was significantly higher in the intervention group at 56.0% (42/75) (95% CI [44.1%, 67.5%]) compared to 39.5% (30/76) in the control group (95% CI [28.4%, 51.4%]) (p=0.008); the proportion achieving target blood pressure levels was 41.2% (28/68) in the intervention group (95% CI [29.4%, 53.8%]) and 34.2% (25/73) in the control group (95% CI [23.5%, 46.3%]) (p=0.396); and the proportion achieving weight management targets (>=3% weight reduction) was 69.6% (48/69) in the intervention group (95% CI [57.3%, 80.1%]) and 63.0% (46/73) in the control group (95% CI [50.9%, 74.0%]) (p=0.409). Only lipid levels showed a significant improvement in the intervention group. In a post hoc analysis of coronary risk factors at 3 months showed the following: the proportion achieving target LDL cholesterol levels was 73.3% (55/75) in the intervention group (95% CI [61.9%, 82.9%]) and 52.6% (40/76) in the control group (95% CI [40.8%, 64.2%]) (p=0.008); the proportion achieving target triglyceride was 69.3% (52/75) in the intervention group 95%CI[57.6%, 79.5%] and 73.7% (56/76) in the control group 95%CI[62.3%, 83.1%] (p=0.554); the proportion achieving target blood glucose levels in patients with diabetes was 66.7% (14/21) in the intervention group 95%CI[43.0%, 85.4%] and 60.9% (14/23) in the control group 95%CI[38.5%, 80.3%] (p=0.690); the proportion achieving weight reduction in patient with a BMI of >=25kg/m2 was 41.2% (14/34) in the intervention group 95%CI[24.6%, 59.3%] and 26.5% (9/34) in the control group 95%CI[12.9%, 44.4%] (p=0.200). In the analysis of health-related QOL using the SF-36, The baseline PCS scores were 49.15 and 47.25 in the intervention and control groups, respectively. The change in the PCS score was 0.37 (standard deviation: SD 7.61) in the intervention group and 2.94 (SD 7.11) in the control group (p=0.041). Similarly, the baseline MCS scores were 51.85 and 51.55, respectively, with change of 3.85 (SD 8.86) in the intervention group and 4.31 (SD 9.30) in the control group (p=0.738). The baseline RCS scores were 52.90 and 51.75, respectively, with changes of 3.37 (SD 11.07) in the intervention group and 4.15 (SD 16.55) in the control group (p=0.911). For MVPA, the change in MVPA was 32.5 (SD 91.5) minutes/week in the intervention group and 12.4 (SD 71.7) minutes/week in the control group (p=0.394). The proportion of participants achieving >=150 minutes/week of MVPA was 49.2% (30/61) in the intervention group (95% CI [36.1%, 62.3%]) and 42.0% (29/69) in the control group (95% CI [30.2%, 54.5%]) (p=0.414). The change in MAGE was 0.4 (SD 14.4) in the intervention group and -3.2 (SD 13.8) in the control group (p=0.107). [Safety] Device-related issues included 54 instances of "data synchronization issue" with the wristwatch pulse monitor, and one instance each of "internet connection issue" and "graph display malfunction."

Remote behavioral modification using a therapeutic application resulted in an improvement of over 10% in peak oxygen uptake in 41.1% of post-PCI patients. However, no significant difference was observed compared to the control group. Regarding the management of coronary risk factors, LDL cholesterol levels were better controlled in the intervention group, demonstrating the efficacy of providing information of risk factor modification to physicians in outpatient clinic. On the other hand, no significant diff

Dec. 31, 2025

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs042220040

Amano Tetsuya

Aichi Medical University Hospital

1-1 Yazakokarimata, Nagakute City, Aichi Prefecture

amanot@aichi-med-u.ac.jp

Amano Tetsuya

Aichi Medical University Hospital

1-1 Yazakokarimata, Nagakute City, Aichi Prefecture

+81-561-62-3311

amanot@aichi-med-u.ac.jp

Complete

Sept. 01, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

Patients underwent percutaneous coronary intervention (PCI) for acute coronary syndrome or chronic coronary syndrome; hope to participate in remote lifestyle intervention after discharge; and are 20 years old or older and provide written informed consent

Patients showing abnormal cardiovascular respons e during electrocardiogram exercise testing; with atrial fibrillation; not capable of using a tablet com puter and IoT device; receiving hemodialysis; considered unsuitable by physicians for participating in remote lifestyle intervention; participating in outpatient cardiac rehabilitation after discharge; not capable of going out alone

Both

acute coronary syndrome, chronic coronary syndrome

The intervention group receives remote lifestyle intervention using web system for 3 months after baseline lifestyle assessment.
The devices used for lifestyle assessment are list-worn pulse monitor with accelerometer, continuous glucose monitoring sensor, sphygmomanometer, weight scale, and a tablet computer. Patients record blood pressure, pulse rate, and body weight, and answer questionnaires including diet using a tablet.
Web-based lifestyle intervention is delivered after the baseline lifestyle assessment. Lifestyle intervention includes home-based exercise training using a list-worn pulse monitor and individualized diet guidance using a tablet. The data of list-worn pulse monitor and dietary information are stored in the server of the data center at Nagoya University.
Individualized feedback based on lifestyle data and educational materials are provided once every two weeks to encourage behavior change. Short-term goals for physical activity and diet are set once every two weeks.
The lifestyle data is also reported to the outpatient physicians for supporting guideline-oriented medication adjustments to controlling coronary risk factors in necessary.

acute coronary syndrome, chronic coronary syndrome

remote lifystyle modification, provide health data to outpatient physicians

C14, C23

Peak oxygen uptake

Coronary risk factors: blood pressure (systolic blood pressure, diastolic blood pressure), lipid profile (triglyceride, low-density lipoprotein cholesterol), blood glucose (HbA1c), and body weight, health-related quality of life, moderate to vigorous physical activity, and mean amplitude of glycemic excursions

+81-561-62-3311

Mar. 18, 2022

none