Health Behaviour and Readiness to Change After Myocardial Infarction: A Cross-sectional Survey (HerzAktiv)
26. august 2026 opdateret af: 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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
143
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Wiebke K Kohl-Heckl, Dr.med.
- Telefonnummer: 004920117425012
- E-mail: w.kohl-heckl@kem-med.com
Studiesteder
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Tyskland
- University Hospital Essen
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Kontakt:
- Andrea Sippel
- Telefonnummer: 0049201723-77374
- E-mail: Andrea.Sippel@uk-essen.de
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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PIAC (Perception, Intention and Ability to Change) Scale
Tidsramme: Single assessement at study enrollment, baseline
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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.
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Single assessement at study enrollment, baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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SF-36 (Short-form 36 Health Survey)
Tidsramme: Single assessement at study enrollment, baseline
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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.
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Single assessement at study enrollment, baseline
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HADS (Hospital Anxiety and Depression Scale)
Tidsramme: Single assessement at study enrollment, baseline
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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.
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Single assessement at study enrollment, baseline
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KCCQ-23 (Kansas City Cardiomyopathy Questionnaire)
Tidsramme: Single assessement at study enrollment, baseline
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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.
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Single assessement at study enrollment, baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: 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
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
- Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
- Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
- Endler NS, Hunt JM. Generalizability of contributions from sources of variance in the S-R inventories of anxiousness. J Pers. 1969 Mar;37(1):1-24. doi: 10.1111/j.1467-6494.1969.tb01728.x. No abstract available.
- Chen JJ, Anand SK, Porter PJ. Infectious mononucleosis with thrombocytopenic purpura. Pediatrics. 1968 Feb;41(2):526-8. No abstract available.
- Lehmann N, Paul A, Moebus S, Budde T, Dobos GJ, Michalsen A. Effects of lifestyle modification on coronary artery calcium progression and prognostic factors in coronary patients--3-year results of the randomized SAFE-LIFE trial. Atherosclerosis. 2011 Dec;219(2):630-6. doi: 10.1016/j.atherosclerosis.2011.08.050. Epub 2011 Sep 6.
- Sanchez Angulo JI, Cuesta Lopez MJ, Zapata Lopez A, Perez Cortes S. [HIV infection and porphyria cutanea tarda]. Enferm Infecc Microbiol Clin. 1997 Aug-Sep;15(7):392-3. No abstract available. Spanish.
- Nguyen XT, Li Y, Wang DD, Whitbourne SB, Houghton SC, Hu FB, Willett WC, Sun YV, Djousse L, Gaziano JM, Cho K, Wilson PW; VA Million Veteran Program. Impact of 8 lifestyle factors on mortality and life expectancy among United States veterans: The Million Veteran Program. Am J Clin Nutr. 2024 Jan;119(1):127-135. doi: 10.1016/j.ajcnut.2023.10.032. Epub 2023 Dec 7.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. september 2026
Primær færdiggørelse (Anslået)
30. marts 2027
Studieafslutning (Anslået)
30. september 2028
Datoer for studieregistrering
Først indsendt
21. august 2026
Først indsendt, der opfyldte QC-kriterier
21. august 2026
Først opslået (Faktiske)
25. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-12963-BO
- Habilitation Scholarship (Andet bevillings-/finansieringsnummer: Karl und Veronika Carstens-Stiftung)
Plan for individuelle deltagerdata (IPD)
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