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临床试验/DRKS00030109
DRKS00030109已完成3 期

Digital lifestyle intervention solution for hypertension

mementor DE GmbH0 个研究点目标入组 102 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
102

研究概览

简要总结

In this pilot study, the authors investigated the preliminary effectiveness of the digital lifestyle intervention, actensio (mementor DE GmbH), in treating arterial hypertension. Adults with arterial hypertension were randomly assigned to an intervention group (actensio + standard care) or a control group (waiting list + standard care) in a 1:1 ratio. Primary and secondary endpoints were assessed at baseline (t0) and 3 months post-randomization (t1). The primary endpoint was average systolic blood pressure, measured at home for 1 week. Secondary endpoints included patient engagement (measured using the “patient activation measure”; PAM-13), average diastolic blood pressure, and heart rate. All endpoints were analyzed using ANCOVA models, following an intention-to-treat approach, while adjusting for baseline values. Missing data were estimated using multiple imputation models. A total of N = 102 participants (f = 59, age = 52.94 ± 9.01) were randomized to either the intervention (IG; N = 52) or the control group (CG; N = 50), of which N = 80 completed the blood pressure diary, and N = 81 the PAM-13 at t1. Between-group comparisons showed an average group difference in systolic blood pressure of -5.06 mm Hg (95% CI = -8.71 to -1.41, p = .013) between the intervention group (M = 137.37 ± 10.13) and the control group (M = 142.35 ± 11.23). Average group difference for patient engagement was 3.35 points with a trend towards statistical significance (95% CI = -018 to 6.89, p = .064), favoring the intervention group (MIG = 79.38 ± 9.44 vs. MCG = 75.45 ± 10.62). There were no group differences in diastolic blood pressure (-1.78 mm Hg; 95% CI = -4.50 to 0.95, p = .402) and heart rate (-0.684; 95% CI = -3.73 to 2.36, p = 0.683). The results of the present pilot study confirm the preliminary effectiveness of the digital lifestyle intervention, actensio, in reducing high blood pressure in patients with hypertension.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Consent to participate in the study
  • - Age >= 18 years
  • - Meet criteria for hypertension (=135/90mmHg & )
  • - Internet access
  • - Able to complete data collection and intervention
  • - Motivated to make lifestyle changes
  • - No or stable antihypertensive medication (i.e. no change in the last 3 months)
  • - Possession of a blood pressure monitor

排除标准

  • - Resistant hypertension (home BP =175mmHg or =4 different classes of blood pressure medication).
  • - Reasons of safety (e.g. pregnancy, diabetes requiring insulin)
  • - Life expectancy <12 months
  • - One person per household (contamination)
  • - Cardiovascular event within the last 6 months (e.g. stroke, heart attack, cerebral haemorrhage)
  • - Cancer diagnosis or acute treatment with chemotherapy/immunosuppressants
  • - Planned health/medication plan change (in the next 3 months)
  • - Planned hospitalisation (in the next 3 months)

研究者

发起方
mementor DE GmbH

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