NCT04474418

Brief Summary

To investigate the influence of different psychological parameters (e.g. depression, anxiety, personality traits, resilience, tolerance of uncertainty or heart beat perception) on treatment outcome and quality of life in patients with cardiac arrythmias.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

July 2, 2020

Last Update Submit

July 15, 2020

Conditions

Cardiac ArrhythmiaAnxietyPersonalityPsychological StressDepression

Keywords

cardiac arrhythmia, personality, psychological symptoms

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory (BDI) - Change from Baseline at 6 months

    BDI is a questionnaire measuring depression

    From Baseline at 6 months (Follow-up) after standard therapy

Secondary Outcomes (26)

  • NEO-FFI personality inventory

    Only at baseline

  • Electrocardiography (ECG) - Change from Baseline at 6 months

    From Baseline at 6 months (Follow-up) after standard therapy

  • Heart beat Counting Task by Schandry

    Baseline

  • Angstkontrollfragebogen (AKF) - Baseline

    Baseline before standard therapy

  • Angstkontrollfragebogen (AKF) - 3 months after standard therapy

    3 months after standard therapy

  • +21 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with cardiac arrythmias without any signs of medium or severe cognitive dysfunction.

You may qualify if:

  • Age of majority (min. 18 years old)
  • no severe cognitive dysfunction
  • diagnosed cardiac arrhythmias
  • reason of admission is the treatment of cardiac arrhythmia

You may not qualify if:

  • medium to severe cognitive dysfunction
  • doubt on capacity to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Arrhythmias, CardiacAnxiety DisordersStress, PsychologicalDepression

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Jens Plag, Dr.

CONTACT

+49 30 450 510 306jens.plag@charite.de

Martin Huemer, Dr.

CONTACT

martin.huemer@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 16, 2020

Study Start

October 9, 2018

Primary Completion

January 1, 2021

Study Completion

August 1, 2021

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

DE(1)