NCT02415517

Brief Summary

The daily routine in clinical settings often showed cognitive impairments in patients with congestive heart failure, particularly in terms of executive functions, episodic memory, perceptual speed and attention. It is assumed that cognitive impairments in patients with congestive heart failure may lead to deficits in medication-adherence and self-care abilities, resulting in increased healthcare costs. Recent studies reported performance improvements after cognitive training that transferred to new, untrained tasks and abilities in healthy subjects across a wide range of ages. This study investigates the effects of cognitive training in patients with congestive heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

5.4 years

First QC Date

April 2, 2015

Last Update Submit

March 24, 2020

Conditions

Congestive Heart FailureCognitive Impairment

Keywords

Cognitive trainingCognitive impairmentHeart failureCognition

Outcome Measures

Primary Outcomes (1)

  • Training effects

    Improvement in performance in the last trainingssession compared with the performance in the first trainingssession. Performance will be assessed by computesoftware.

    3 weeks

Secondary Outcomes (4)

  • Transfer effects

    5 weeks

  • Changes in quality of life and psychological well-being

    5 weeks

  • Long-term benefits of cognitive training in patients with congestive heart failure.

    6 month

  • Compliance with medication

    5 weeks

Study Arms (3)

Experimental group

EXPERIMENTAL

Intervention: Cognitive Training

Behavioral: Cognitive training

Active control group

ACTIVE COMPARATOR

Intervention: Test of general knowledge

Behavioral: Test of general knowledge

Passive control group

NO INTERVENTION

No intervention

Interventions

Cognitive trainingBEHAVIORAL

Cognitive training on computer. Six sessions with different tasks: "Tiere merken" \& "Räumlich visuelles Training" (application BrainTwister) and "Taskswitching" (programmed with eprime)

Experimental group
Test of general knowledgeBEHAVIORAL

Training of general knowledge on computer. Six sessions with different topics.

Active control group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Congestive heart failure
  • NYHA II-III

You may not qualify if:

  • Psychosis
  • Dementia
  • Major depression
  • Reanimation (\<3month)
  • Patients with assist device system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Educational Science, Saarland University

Frankfurt am Main, Hesse, 60323, Germany

Location

Clinic for Internal Medicine, Cardioloy, Angioloy, and Internal Intensive Care Medicine, Saarland University Hospital

Homburg, Saarland, 66421, Germany

Location

Related Publications (1)

  • Wedegartner SM, Schwantke I, Kindermann I, Karbach J. Predictors of heart-focused anxiety in patients with stable heart failure. J Affect Disord. 2020 Nov 1;276:380-387. doi: 10.1016/j.jad.2020.06.065. Epub 2020 Jul 15.

    PMID: 32871668DERIVED

MeSH Terms

Conditions

Heart FailureCognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ingrid Kindermann, PD Dr.med.

    University Hospital, Saarland

    STUDY DIRECTOR

  • Julia Karbach, Prof.

    Goethe-Universität Frankfurt am Main

    STUDY DIRECTOR

  • Sonja Wedegärtner, Dipl.Psych.

    University Hospital, Saarland

    PRINCIPAL INVESTIGATOR

  • Maxie Bunz, Dipl.Psych.

    University Hospital, Saarland

    PRINCIPAL INVESTIGATOR

  • Michael Böhm, Prof.

    University Hospital, Saarland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were enrolled in Treatment-Group, Waitinglist-Group, or Shamtraining-Group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pre-Test, Intervention, Post-Test, Follow-Up
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipl. Psych.

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 14, 2015

Study Start

January 1, 2014

Primary Completion

June 3, 2019

Study Completion

December 4, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Locations

DE(2)