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Accepted for/Published in: JMIR Cardio

Date Submitted: Dec 22, 2022
Date Accepted: May 9, 2023
Date Submitted to PubMed: May 10, 2023

The final, peer-reviewed published version of this preprint can be found here:

Determining Optimal Intervals for In-Person Visits During Video-Based Telemedicine Among Patients With Hypertension: Cluster Randomized Controlled Trial

Nishizaki Y, Kuroki H, Ishii S, Ohtsu S, Watanabe C, Nishizawa H, Nagao M, Nojima M, Watanabe R, Sato D, Sato K, Kawata Y, Wada H, Toyoda G, Ohbayashi K

Determining Optimal Intervals for In-Person Visits During Video-Based Telemedicine Among Patients With Hypertension: Cluster Randomized Controlled Trial

JMIR Cardio 2023;7:e45230

DOI: 10.2196/45230

PMID: 37161483

PMCID: 10288346

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Determining Optimal Intervals for In-Person Visits during Video-based Telemedicine in Patients with Hypertension: A Cluster Randomized Controlled Trial

  • Yuji Nishizaki; 
  • Haruo Kuroki; 
  • So Ishii; 
  • Shigeyuki Ohtsu; 
  • Chizuru Watanabe; 
  • Hiroto Nishizawa; 
  • Masashi Nagao; 
  • Masanori Nojima; 
  • Ryo Watanabe; 
  • Daisuke Sato; 
  • Kensuke Sato; 
  • Yumi Kawata; 
  • Hiroo Wada; 
  • Goichiro Toyoda; 
  • Katsumi Ohbayashi

ABSTRACT

Background:

The introduction of telemedicine as part of outpatient treatment may improve patient satisfaction and convenience. However, the optimal in-person visit interval during video-based telemedicine in patients with hypertension has not yet been reported in Japan.

Objective:

To determine the optimal in-person visit interval during video-based telemedicine in patients with hypertension.

Methods:

This cluster randomized controlled trial was conducted as a noninferiority trial. The target sites were eight clinics in Japan that had a telemedicine system, and the target patients were patients with essential hypertension. In patients receiving video-based telemedicine, those who underwent in-person visit at 6-month intervals were designated as the intervention group, and the regular patients who underwent in-person visit at 3-month intervals were the control group. The follow-up period was 6 months, and the primary endpoint was the change in systolic blood pressure. Secondary endpoints were the rate of treatment continuation after 6 months, patient satisfaction, health economic evaluation, and safety evaluation.

Results:

Sixty-four patients were enrolled (31 in the intervention group and 33 in the control group). The mean age was 54.5 ± 10.3 years, and 39 (60.9%) patients were male. Patients’ characteristics such as diabetes, dyslipidemia, smoking, alcohol drinking, and family history of hypertension were not different between the intervention and control groups. For the primary endpoint, the estimated difference in the change in systolic blood pressure between the two groups was 1.18 (90% confidence interval −3.68 to 6.04). The criteria for non-inferiority in this study were met. Patient satisfaction was higher in the intervention group than in the control group, particularly the “satisfaction with consultation time” and “satisfaction with the conversation with the physician.” Furthermore, the health economic evaluation results showed no significant difference in the 3-month average direct medical costs between the two groups. The indirect costs, calculated by converting lost productivity hours into yen, showed that lost productivity was significantly less in the intervention group than in the control group. The treatment continuation rate at the 6-month follow-up also did not differ between the intervention group (100%, 31/31) and the control group (97.0%, 32/33) (P = 0.51), with no adverse events in either group.

Conclusions:

Blood pressure control status and safety did not differ between patients with stable essential hypertension receiving telemedicine at 3-month intervals and those at 6-month intervals. The 6-month interval may cause a societal cost-reduction effect and improve patient satisfaction. Clinical Trial: UMIN000040953


 Citation

Please cite as:

Nishizaki Y, Kuroki H, Ishii S, Ohtsu S, Watanabe C, Nishizawa H, Nagao M, Nojima M, Watanabe R, Sato D, Sato K, Kawata Y, Wada H, Toyoda G, Ohbayashi K

Determining Optimal Intervals for In-Person Visits During Video-Based Telemedicine Among Patients With Hypertension: Cluster Randomized Controlled Trial

JMIR Cardio 2023;7:e45230

DOI: 10.2196/45230

PMID: 37161483

PMCID: 10288346

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