Innsbruck Health Promotion Program

NCT ID: NCT06813677

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-03-31

Brief Summary

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

Detailed Description

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

Conditions

Assessment of Vascular Health Risk Factors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Health promotion arm

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.

Group Type: EXPERIMENTAL

In-person health promotion

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Signed informed consent of subject
• Main area of residence in Innsbruck and Innsbruck-Land

Exclusion Criteria

• People who are suspended upon a court order or upon other legal processes or are accommodated according ot the Hospitalization Act, or for whom a custodian is appointed (or appointment is inititated)
• Persons with impaired power of judgement
• Persons who are currently engaged in military or community service

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oroboros Instruments

UNKNOWN

Sponsor Role: collaborator

Med-El Corporation

INDUSTRY

Sponsor Role: collaborator

Tirol Kiniken GmbH

OTHER

Sponsor Role: collaborator

Österreichische Gesundheitskasse

UNKNOWN

Sponsor Role: collaborator

VASCage GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr.med. Lukas Mayer-Süß, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Innsbruck

Locations

Medical University Innsbruck - Department of Neurology

Innsbruck, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Muriel Harloff, MSc

Role: CONTACT

muriel.harloff@vascage.at

+ 43 51255443513

Petr Simurda, MD

Role: CONTACT

petr.simurda@vascage.at

+ 43 51255443513

Facility Contacts

Lukas Mayer-Süß, Dr.med.

Role: primary

lukas.mayer@i-med.ac.at

+43 512 504 83127

Other Identifiers

C_2_A.2-0062_012

Identifier Type: -

Identifier Source: org_study_id