- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07785921
Health Behaviour and Readiness to Change After Myocardial Infarction: A Cross-sectional Survey (HerzAktiv)
Cardiovascular Risk Behavior and Readiness for Lifestyle Change After Myocardial Infarction: A Cross-sectional Questionnaire Study (HERZ-AKTIV)
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Wiebke K Kohl-Heckl, Dr.med.
- Phone Number: 004920117425012
- Email: w.kohl-heckl@kem-med.com
Study Locations
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Germany
- University Hospital Essen
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Contact:
- Andrea Sippel
- Phone Number: 0049201723-77374
- Email: Andrea.Sippel@uk-essen.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PIAC (Perception, Intention and Ability to Change) Scale
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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SF-36 (Short-form 36 Health Survey)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
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
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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