Health Behaviour and Readiness to Change After Myocardial Infarction: A Cross-sectional Survey (HerzAktiv)

August 26, 2026 updated by: Kohl, Wiebke, Kliniken Essen-Mitte

Cardiovascular Risk Behavior and Readiness for Lifestyle Change After Myocardial Infarction: A Cross-sectional Questionnaire Study (HERZ-AKTIV)

This study investigates health behaviour and readiness for lifestyle change in patients who recently had a heart attack (myocardical infarction) treated with stenting (PTCA). Despite successful acute treatment, many patients remain at increased risk of a second heart atttack because lifestyle changes are not consistently maintained. Participants who had a heart attack within the past 6 months will complete standardized questionnaires on readiness to change, quality of life, anxiety/depression, and physical functioning, plus a free-text section on personal barriers to change. Findings will characterize this population and inform a future lifestyle intervention trial

Study Overview

Status

Not yet recruiting

Detailed Description

Cardiovascular diseses are the leading cause of deaths in Germany and worldwide. Even after successfull PTCA, reinfarction rates remain elevated, partly because patients often underestimate their ongoing risk, have limited knowledge of secondary prevention targets and show low self-efficacy for behavior change; anxiety and depression are also common after myocardial infarction.

This single-center, cross-sectional study enrolls patients treated with PTCA within the past 6 months, recruited during their routine follow-up visit at the Lipidambulanz, Westdeutsches Herz- und Gefäßzentrum, University Hospital Essen. Participants complete validated questionnaires: PIAC (primary outcome; rediness to change), SF-36 (quality of life); HADS (anxiety/depression), and KCCQ-23 (physical functioning), plus sociodemographic data and free-text section on perceived barriers.

This study is purely observational, involves no interventions or biospecimens and takes about 30 minutes. A sample of 143 participants was calculated for adequate precision in estimating the PIAC meand and supporting exploratory regression analyses, accounting for 10% dropout. Data collection runs 6 months, followed by 18 months of analysus. Results wull inform a planned randomized controlled trial.

Study Type

Observational

Enrollment (Estimated)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from the catchment area of the Westdeutsches Herz- und Gefäßzentrum, University Hospital Essen, treated for acute myocardial infarction with PTCA. Recruitment and eligibility screening take place during the routine post-discharge follow-up visit at the Lipidambulanz, within approx. 3 months. after the index event. creening is performed by the treating physician within the existing doctor-patient relationshop, without recording study-specifix personal data. Eligible patients are approached in person by a stdy physician and enrolled only after written informed consent.

Description

Inclusion Criteria:

  • age over 18 years
  • myocardial infarction within past 6 months
  • PTCA treatment

Exclusion Criteria:

  • Age under 18
  • history of multiple myocardial infactionrs
  • myocardial infarction more than 6 months prior
  • myocardial infarction not treated by PTCA
  • absence of informed consent
  • severe cognitive impairment precluding data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Post-Myocardial Infarction Patients
Patients aged 18 years or older who experienced a myocardical infarction within the past 6 months, treated with percutaneous transluminal coronary angioplasty (PTCA), and recruited during ther routine post-discharge follow-up visit at the Lipidambulanz (lipid outpatient clinic), Westdeutsches Herz- und Gefäßzentrum, University Hospital Essen. Participants complete a one-time set of questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PIAC (Perception, Intention and Ability to Change) Scale
Time Frame: Single assessement at study enrollment, baseline
Readiness and ability to change health-related behavior, habits and living conditions, assessed using the PIAC questionnaire, a validated 9 item instrument covering awareness of negative health behaviors, intention to change and implementation of change strategies. Higher scores indicate a better awareness and intention to change.
Single assessement at study enrollment, baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 (Short-form 36 Health Survey)
Time Frame: Single assessement at study enrollment, baseline
Health-related quality of life assessed using the SF-36, yielding a physical and a mental summary score; higher scores indicate better quality of life.
Single assessement at study enrollment, baseline
HADS (Hospital Anxiety and Depression Scale)
Time Frame: Single assessement at study enrollment, baseline
Anxiety and depressive Symptoms assessed using the HADS(-A) for Anxiety and HADS-(D) for depression. each ssubscales ranges from 0-21; higher scores indicate greater severity.
Single assessement at study enrollment, baseline
KCCQ-23 (Kansas City Cardiomyopathy Questionnaire)
Time Frame: Single assessement at study enrollment, baseline
Disease-specific health status using the KCCQ-23 covering physical limitations, symptoms, self-efficacy, social limitation and quality of life. Scores ranging 0-100 with higher scores indicating better health status.
Single assessement at study enrollment, baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wiebke Kohl, Dr.med, Center for Integrative Medicine and Planetary Health, University Hospital Essen
  • Study Director: Gustav Dobos, Prof. Dr. med., Center for Integrative Medicine and Planetary Health, University Hospital Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

August 21, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 26-12963-BO
  • Habilitation Scholarship (Other Grant/Funding Number: Karl und Veronika Carstens-Stiftung)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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