Exploratory study (pilot study) on the feasibility of a large-scale RCT to demonstrate a positive health care effect of a digital health application for self-management of high blood pressure (TONY app)

Exploratory study (pilot study) on the feasibility of a large-scale RCT to demonstrate a positive health care effect of a digital health application for self-management of high blood pressure (TONY app) - TONY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037318

Enrollment

150

Registered

2025-07-02

Start date

2025-04-11

Completion date

Unknown

Last updated

2025-10-06

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). Care as usual + Tony app for 90 days for use. Group 2: Control group (CG). Care as usual + information brochure. Optional, at the end of the study period: Tony app fo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Fulfillment of the criteria for high blood pressure (=140/90 to <180/110 mmHg) Motivation to deal with the disease / change lifestyle Possession of a functioning upper arm blood pressure monitor that bears the German Hypertension League's seal of approval for measurement accuracy Age = 18 years Terminal device for using the Tony app with Internet access Valid private e-mail address

Exclusion criteria

Exclusion criteria: Severe hypertension (SBP =180 mmHg) Confirmed sleep apnea Cardiovascular event within the last 6 months (e.g. stroke, heart attack, cerebral hemorrhage) Current medication adjustment of antihypertensives during the study baseline (V1) Lack of German language skills Work in 24-hour shifts (e.g. rescue service, fire department) Use of another program to lower blood pressure (DiGA, app, etc.) Another person in the household uses the Tony app.

Design outcomes

Primary

Measure	Time frame
Comparison of the reduction in systolic blood pressure (SBP; home self-measurement) between visit 1 (V1) and visit 5 (V5; study baseline and after 12 weeks) in the intervention group compared to the control group.	—

Secondary

Measure	Time frame
- Difference in patient adherence to medication between V1 and V5 using the A14 scale - Difference in patient activation between V1 and V5 using the PAM-13-D questionnaire - Difference in patients' physical quality of life (SF-12 PCS) between V1 and V5	—

Countries

Germany

Contacts

Public ContactVedat Schwenger

Klinikum der Landeshauptstadt Stuttgart gKAöR

buero.schwenger@klinikum-stuttgart.de+49 711 278 35301

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026