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

26. august 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

143

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Wiebke K Kohl-Heckl, Dr.med.
Telefonnummer: 004920117425012
E-post: w.kohl-heckl@kem-med.com

Studiesteder

Tyskland
- North Rhine-Westphalia
  - Essen, North Rhine-Westphalia, Tyskland
    - University Hospital Essen
    - Ta kontakt med:
      
      Andrea Sippel
      
      Telefonnummer: 0049201723-77374
      
      E-post: Andrea.Sippel@uk-essen.de

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Gruppe / Kohort

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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
PIAC (Perception, Intention and Ability to Change) Scale Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
SF-36 (Short-form 36 Health Survey) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kliniken Essen-Mitte

Samarbeidspartnere

Universitätsklinikum Essen

Etterforskere

Hovedetterforsker: Wiebke Kohl, Dr.med, Center for Integrative Medicine and Planetary Health, University Hospital Essen
Studieleder: Gustav Dobos, Prof. Dr. med., Center for Integrative Medicine and Planetary Health, University Hospital Essen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. september 2026

Primær fullføring (Antatt)

30. mars 2027

Studiet fullført (Antatt)

30. september 2028

Datoer for studieregistrering

Først innsendt

21. august 2026

Først innsendt som oppfylte QC-kriteriene