I10
Conditions
Interventions
Group 1: The intervention group receives the digital intervention actensio in combination with standard care according to the national care guideline (AWMF register no. nvl-009).
Group 2: The control
Sponsors
mementor DE GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Consent to participate in the clinical trial - Age over 18 years - Diagnosis of essential hypertension (practice SBP 140-179 mmHg and/or DBP 90-109 mmHg; 24-h SBP=130- mmHg and/or 24-h DBP=80) - Internet access and computer/smartphone compatible with actensio - Able to complete data collection and intervention - Ability to speak and read German - Antihypertensive medication (prescribed by a doctor) that has been stable over the last 3 months (i.e. not changed) or no antihypertensive medication - Possession of a blood pressure monitor - Patients are able to participate fully in the clinical trial and comply with the requirements for participation
Exclusion criteria
Exclusion criteria: - Taking = 4 different classes of blood pressure medication - Practice SBP = 180 and/or DBP = 110 - Life expectancy < 12 months - Cardiovascular event within the last 6 months (e.g. stroke, heart attack, cerebral haemorrhage) - Cancer diagnosis in the past 5 years or acute treatment with chemotherapy/immonosuppressants - Current or planned pregnancy during the clinical trial; breastfeeding women - cognitive impairment - Participation in another clinical drug trial or medical device trial - current or recent (within the last six months) participation in a lifestyle intervention programme (e.g. sports or diet programme) - Employees of mementor or another institution involved in the conduct/organisation/coordination/financing of the clinical trial - Relatives or life partners who have already participated in this clinical trial - Previous use of actensio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic 24h ABPM blood pressure of the patient measured with a 24-h ABMP blood pressure measurement at the baseline visit (T0) and after 6 months (T1). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Diastolic 24h ABPM blood pressure of the patient measured with a 24-h ABMP blood pressure measurement at the baseline visit (V0) and after 6 months (V2). - BMI: Weight and height are measured on a calibrated scale, which is used to calculate BMI. The measurement is taken at the baseline visit (V0) and after 6 months (V2). - Waist circumference: Waist circumference is measured with a standardised tape measure. It is recorded at the baseline visit (V0) and after 6 months (V2). - Self-management: Self-management of hypertension will be assessed using the Patient Activation Measure 13 (PAM13-D) questionnaire at the baseline visit (V0), after 3 months by televisit (V1) and after 6 months (V2). - Health-related quality of life: Health-related quality of life is assessed with the generic Short-Form Questionnaire (SF)-12 at the baseline visit (V0) and after 6 months (V2). - Medication adherence: Medication adherence will be assessed using the MMAS-8 questionnaire at the baseline visit (V0) and after 6 months (V2). - Percentage of medication users: The number and classes of blood pressure medications are recorded using a multiple-choice questionnaire at the baseline visit (V0) and after 6 months (V2). - Adverse events: If (serious) adverse events occur in the course of participation in the trial between visit times V0 and V2, subjects are encouraged to report them to their trial site. There is the possibility of an unscheduled visit to review the reported (serious) adverse event. - App usage rate and progress in the app: The collection of usage time and frequency is done by means of app-internal and patient-reported data exclusively in the intervention group at visit V2. - Lifestyle intervention measures: Other measures of recommended lifestyle intervention for hypertension will be collected using a multiple choice format. choice" format at visits V1 and V2. | — |
Countries
Germany
Contacts
Public ContactChristoph Schöbel
Universitätsklinikum Essen Schlafmedizinisches Zentrum
Outcome results
None listed