Fighting Social Inequality in Cardiovascular Health I
FISICH-I
1 other identifier
interventional
5,000
1 country
5
Brief Summary
This study attempts to reduce social inequality in cardiovascular health by performing an interventional screening trial on how best to decrease cardiovascular disease (CVD) among people with low social status
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedFirst Submitted
Initial submission to the registry
May 9, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedMay 14, 2019
May 1, 2019
1.7 years
May 9, 2019
May 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attendance rate to screening
The proportion of invited attending screening
6 months
Secondary Outcomes (1)
Quality of Life of invitation to screening
6 months
Study Arms (4)
Prebooking
ACTIVE COMPARATORParticipants randomised to this arm receives a prebooked appointment to screening
Web based booking
PLACEBO COMPARATORParticipants randomised to this arm receives an invitation to book a screening appointment webbased or by contacting the trial office.
Pictured invitation
ACTIVE COMPARATORParticipants randomised to this arm receives a pictured invitation to screening
Texted invitation
PLACEBO COMPARATORParticipants randomised to this arm receives a classical texted invitation to screening
Interventions
Participants are receiving a prebooked appointment for CVD screening or being invited to book an appointment for CVD Screening
Participants are receiving an illustrated invitation CVD screening or a classical text-invitation to book an appointment for CVD Screening
Eligibility Criteria
You may qualify if:
- Men aged 60-64 living in the municipalities of Funen, Silkeborg, Vejle and surrounding municipailties
You may not qualify if:
- Men not aged 60-65
- Men not living in the mentioned municipalities
- Women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Regionshospitalet Silkeborgcollaborator
- Vejle Hospitalcollaborator
- Svendborg Hospitalcollaborator
- Nykøbing Falster Hospitalcollaborator
Study Sites (5)
Nykøbing Falster Sygehus
Nykøbing Falster, 4800, Denmark
Odense University Hospital
Odense, 5000, Denmark
Region Hospital Silkeborg
Silkeborg, 8600, Denmark
Svendborg Sygehus
Svendborg, 5700, Denmark
Vejle Hospital
Vejle, 7100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jes S Lindholt
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 9, 2019
First Posted
May 13, 2019
Study Start
August 1, 2017
Primary Completion
March 31, 2019
Study Completion
March 31, 2019
Last Updated
May 14, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
Data will be analysed on Statistics Denmarks secured server