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Investigation of the positive care effect of the Tony app, a digital health application for the self-management of hypertension (hyperTONY)

Investigation of the positive care effect of the Tony app, a digital health application for the self-management of hypertension (hyperTONY) - hyperTONY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037321
Enrollment
686
Registered
2025-07-02
Start date
2025-08-08
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I10

Interventions

Group 1: Intervention group (IG). Participants use the Tony app for a total of 6 months in addition to care as usual. Group 2: Control group (CG). Participants receive an information brochure on the t

Sponsors

Sanero Medical GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosed hypertension (= 135/85 to < 180/110 mmHg) - Motivation to deal with the disease / make lifestyle changes - Use of the provided Beurer upper arm blood pressure monitor - Age = 18 Jahre - Device with internet access for using the Tony app - Possession of a valid private e-mail address

Exclusion criteria

Exclusion criteria: - Severe hypertension (SBP =180mmHg) - Confirmed sleep apnoea - Safety of the patient when using the Tony app not given in the opinion of the doctor (e.g. presence of contraindications, illnesses treated with medication such as cancer or mental problems, planned hospital stays during the study period) - Cardiovascular event within the last 6 months (e.g. stroke, heart attack, cerebral hemorrhage) - Planned hospitalization or currently ongoing medication adjustment of antihypertensives at/during the study baseline (t0) - Lack of German language skills - Work in 24-hour shifts (e.g. rescue service, fire department) - Participation in another program or use of another app to lower blood pressure or previous use of the Tony app - Another person in the household uses the app

Design outcomes

Primary

MeasureTime frame
Difference in the reduction of systolic blood pressure between baseline (t0) and after six months (t2) in the intervention group compared to the control group. Measured using home blood pressure monitoring (HBPM) over a seven-day measurement week (morning + evening blood pressure measurements) at t0 and t2.

Secondary

MeasureTime frame
- Difference in patient adherence to medication from t0 to t2 between intervention and control group using the A14 scale - Difference in patient activation from t0 to t2 between intervention and control group using the PAM-13-D questionnaire - Difference in physical quality of life (SF-12 PCS) of patients from t0 to t2 between intervention and control group

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026