Digital lifestyle intervention solution for hypertensio
- Conditions
- I10.9
- Registration Number
- DRKS00030109
- Lead Sponsor
- mementor DE GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 102
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
- 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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of actensio + care as usual versus care as usual on systolic blood pressure.<br>The mean systolic blood pressure at baseline, measured over seven days in the morning and evening at home, will be compared with the mean systolic blood pressure measured over seven days in the morning and evening at home after three months after inclusion. Data are collected via a digital blood pressure diary
- Secondary Outcome Measures
Name Time Method Comparison of actensio + care as usual versus care as usual on diastolic and mean blood pressure and pulse, and the PAM-13 patient activation questionnaire.