NCT04766125

Brief Summary

The study investigates the effect of adverse event information on adverse event occurrence in patients undergoing elective cardiac surgery in a two-armed, randomized study. One group will receive standard information about adverse events; the second group will receive a standardised elaboration of the standard information. Hypothesis: Elaborated information about adverse events will increase adverse event occurrence, mediated by expectations and anxiety, and moderated by coping style.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

February 18, 2021

Last Update Submit

April 3, 2025

Conditions

Heart Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    Assessed on day four

Secondary Outcomes (4)

  • Number of adverse events

    Assessed on day 30, 90, and 180

  • Intensity of experienced adverse events

    Assessed on day four, 30, 90, and 180

  • Hospital readmission

    Assessed on day 180

  • Occurrence of specific adverse events

    Assessed on day four, 30, 90, and 180

Study Arms (2)

Standard adverse event information

OTHER
Behavioral: Adverse event information

Elaborated adverse event information

OTHER
Behavioral: Adverse event information

Interventions

Adverse event informationBEHAVIORAL

All patients have access to the standard material about adverse events related to the surgery. One arm will additionally receive elaborated adverse event information from a nurse and a surgeon

Elaborated adverse event informationStandard adverse event information

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18 and older) undergoing elective cardiac surgery at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

You may not qualify if:

  • Patients who have previously had cardiac surgery
  • Cardiac surgery with deep hypothermia (\<32 degrees Celsius)
  • Acute surgery
  • Patients with psychiatric or neurological disease who are unable to collaborate with the study protocol
  • Patients who do not speak/read Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, Aarhus, 8000, Denmark

Location

Study Officials

  • Mette Sieg

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 23, 2021

Study Start

February 18, 2021

Primary Completion

December 15, 2023

Study Completion

June 12, 2024

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)