Medical University Innsbruck - Department of Neurology
Innsbruck, Austria
Location status: Recruiting
Location contact
Lukas Mayer-Süß, Dr.med.
CONTACT
Lukas Mayer-Süß, Dr.med.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06813677
The primary goal of this single-centre. single-arm, unblinded, pre-post interventional study is to evaluate whether a one-time health assessment and intervention affects the overall vascular health evaluated through the Life's Essential 8 overall vascular health score.
Secondary goals of this study are, among others:
* to describe incidence and prevalence of vascular risk-factors and behaviours * to explore prevalence and associations of health and disease in the general population with special focus on cardiovascular risk, cardiovascular diseases, markers of vascular health, signs and (prodromal) symptoms of neurodegeneration as well as psychosocial factors * to explore the prevalence of hearing disorders in the general population * to collect voice and speech samples to identify novel biomarkers that correlate to vascular health and/or hearing status
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Innsbruck, Austria
Location status: Recruiting
Lukas Mayer-Süß, Dr.med.
CONTACT
Lukas Mayer-Süß, Dr.med.
PRINCIPAL_INVESTIGATOR
Cardio- and cerebrovascular diseases are the leading cause of death and disability globally, underscoring the need for primary prevention, especially given that 80% of stroke patients in Tyrol had untreated risk conditions prior to their stroke.
The American Heart Association (AHA) and the American Stroke Association (ASA) identify eight factors that have a fundamental influence on vascular health, collectively known as "Life's Essential 8" or "LE8." The LE8 includes blood pressure, blood sugar, LDL cholesterol, BMI (Body Mass Index), as well as physical activity, sleep, a balanced diet, and avoiding nicotine products.
The INN.HEALTH study aims to evaluate the impact of a single health examination with counseling, supplemented by bi-monthly motivational newsletters, on improving vascular health over one year among a large cohort of Tyrolean adults. For this purpose, 1000 participants (500 men, 500 women) from various age groups are recruited and comprehensively characterized in terms of their demographic information and clinical profiles.
During the initial baseline pre-examination (study visit 1), blood, urine and stool samples are collected, and selected participants receive an actigraphy device for monitoring activity patterns. Additionally, participants complete self-administered questionnaires about their lifestyle habits. Two weeks post pre-examination (baseline, study visit 2) physical assessments and cognitive and sensory tests are performed. Based on these results the participant's health status in relation to the LE8 factors is assessed and the reduction of identified risk factors is discussed in a counseling session. If certain findings require further clarification, participants are referred to a specialist for further evaluation and treatment.One year after the initial examinations, participants are scheduled for two additional appointments: the first one (study visit 3) is identical to the initial baseline pre-examination, the second one marks the final examination (study visit 4), and is identical to baseline.
Over the 12 months between study visits 2 and 3 participants receive regular newsletters as part of the health promotion program, informing them about vascular health promotion opportunities in the region.
In the final consultation at the end of the final examination visit, participants receive a comprehensive assessment of which aspects of their lifestyle have significantly changed over the past year. Participants are then provided with tailored guidance on further optimizing their vascular health to reduce individual risks of stroke and heart attack.
Secondary objectives of this study include analyzing changes in quality of life, medication compliance, healthcare usage, vascular and cognitive health, as well as identifying risk factors and early markers for neurodegenerative disease, with data collected and periodically reviewed long-term. The study also seeks to establish a regional cohort with a biobank for future research on vascular health, aging, and mitochondrial function, and to explore the feasibility of incorporating hearing screenings into routine health exams
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The results from the initial pre-baseline examination are reviewed during the baseline visit to identify potential risk factors related to the Life's Essential 8 (LE8). Based on these findings, participants receive personalized recommendations to enhance their vascular health and information on local vascular health promotion resources. Additionally, participants receive bi-monthly motivational newsletters designed to support ongoing vascular health improvements.
Time frame: Pre-baseline examination (day 0)
Changes in Life's Essential 8 (LE8) overall cardiovascular health metric between baseline and follow-up examination.
Scores are categorized as low (0-49), moderate (50-79), or high (80-100). A higher LE8 score indicates better cardiovascular health and is associated with a lower risk of cardiovascular diseases (CVD) and mortality.
Time frame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
Assessment of change in diet using the Food Frequency Questionnaire
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Assessment of change in diet using the Mediterranean Eating Pattern for Americans (MEPA) Score. Score minimum 0, score maximum 100. A higher score indicates a diet closely aligned with the mediterranean eating pattern.
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Assessment of change in physical activity with focus on amount and intensity of physical activity
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Assessment of change in smoking status
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Assessment of change in body weight (body mass index, kg)
Time frame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
Assessment of change in blood lipid levels: triglyceride (mmol/L), cholesterol (all, mmol/L)
Time frame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
Assessment of change in blood glucose levels: fasting glucose (mg/dL, mmol/L)
Time frame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
Assessment of changes in blood glucose levels: HbA1c (%)
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Assessment of change in blood pressure (systolic/diastolic, mmHg)
Time frame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
Assessment of change in sleep quality using the Pittsburgh Sleep Quality Index
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Assessment of change in sleep habits
Contact information is provided by the study sponsor or research team.
Muriel Harloff, MSc
CONTACT
Petr Simurda, MD
CONTACT
VASCage GmbH
Other
Acronym: INNHEALTH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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