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

26 agosto 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

143

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Wiebke K Kohl-Heckl, Dr.med.
Numero di telefono: 004920117425012
Email: w.kohl-heckl@kem-med.com

Luoghi di studio

Germania
- North Rhine-Westphalia
  - Essen, North Rhine-Westphalia, Germania
    - University Hospital Essen
    - Contatto:
      
      Andrea Sippel
      
      Numero di telefono: 0049201723-77374
      
      Email: Andrea.Sippel@uk-essen.de

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
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.

Gruppo / Coorte

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
PIAC (Perception, Intention and Ability to Change) Scale Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
SF-36 (Short-form 36 Health Survey) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Kliniken Essen-Mitte

Collaboratori

Universitätsklinikum Essen

Investigatori

Investigatore principale: Wiebke Kohl, Dr.med, Center for Integrative Medicine and Planetary Health, University Hospital Essen
Direttore dello studio: Gustav Dobos, Prof. Dr. med., Center for Integrative Medicine and Planetary Health, University Hospital Essen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 settembre 2026

Completamento primario (Stimato)

30 marzo 2027

Completamento dello studio (Stimato)

30 settembre 2028

Date di iscrizione allo studio

Primo inviato

21 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità