An interventional study of In-person health promotion in Assessment of Vascular Health Risk Factors, sponsored by VASCage GmbH. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by VASCage GmbH · Not applicable, Interventional, and Screening
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:
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
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →VASCage GmbH is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Over a time period of 12 months participants will receive regular newsletters as part of the health promotion program, informing them about vascular health promotion opportunities in the region. At the end of the study participants are provided with tailored guidance on further optimizing their vascular health to reduce individual risks of stroke and heart attack.
Other: In-person health promotion
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.
Life's Essential 8 overall cardiovascular health
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: Pre-baseline examination (day 0)
Changes in individual components of Life's Essential 8 - Diet
Assessment of change in diet using the Food Frequency Questionnaire
Time frame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
Changes in individual components of Life's Essential 8 - Diet
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)
Changes in individual components of Life's Essential 8 - Physical activity
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)
Changes in individual components of Life's Essential 8 - Nicotine Exposure
Assessment of change in smoking status
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Changes in individual components of Life's Essential 8 - Body weight
Assessment of change in body weight (body mass index, kg)
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Changes in individual components of Life's Essential 8 - Blood lipids
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)
Changes in individual components of Life's Essential 8 - Body glucose
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)
Changes in individual components of Life's Essential 8 - Blood glucose
Assessment of changes in blood glucose levels: HbA1c (%)
Time frame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
Changes in individual components of Life's Essential 8 - Blood pressure
Assessment of change in blood pressure (systolic/diastolic, mmHg)
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Changes in individual components of Life's Essential 8 - Sleep
Assessment of change in sleep quality using the Pittsburgh Sleep Quality Index
Time frame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
Changes in individual components of Life's Essential 8 - Sleep
Assessment of change in sleep habits
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Started May 2025 (actual). Primary completion is estimated for Jan 2027, 20 months after the start.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 20 months is below that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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