Pilot Study of a Digital Health Application for Strengthening Self-Management and Adherence to Therapy Guidelines in Patients with Hypertension, Hypertension, and concomitant Chronic Ischemic Heart Disease, and/or Heart Failure

Not Applicable

• Conditions: I10; I25; I50; Essential (primary) hypertension; Chronic ischaemic heart disease; Heart failure

• Registration Number: DRKS00026136
• Lead Sponsor: apprevent GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-23
• Study Completion: 2022-01-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

the patient’s informed consent; being at least 18 years old; the ability to read and understand the
German language; at least one diagnosis of hypertension (ICD-10: I10) with antihypertensive medication; owning a smartphone and being able to use it

Exclusion Criteria

having had an acute cardiovascular event (e.g., a myocardial infarction) within the previous four weeks;
pregnancy; active psychosis or severe dementia (according to the instructions for use of reCardial app); prior use of reCardial app; simultaneous participation in another study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At baseline (pre-intervention), as well as at 12-week follow-up (post-intervention) all study participants will receive an online questionnaire. In line with the intended purpose of reCardial as a medical device, therapy guideline adherence after 12 weeks will be the primary endpoint. It will be assessed using the Self-Care of Hypertension Inventory (SC-HI) - Section A (Self-care Maintenance). The score is standardized from 0 to 100.

Secondary Outcome Measures

Name	Time	Method
All secondary endpoints will be collected with an online questionnaire completed by the patients at baseline (pre-intervention), as well as at 12-week follow-up (post-intervention). The online questionnaires include the following validated instruments for patient-reported outcomes:<br>Self-Efficacy (Self-Care of Hypertension Inventory - Section C (Self-Management)), and Physical Activity (short version of the International Physical Activity Questionnaire (IPAQ-S)).