Cognitive Training in Heart Failure Study (CogTrain-HF)

NCT ID: NCT02415517

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-12-04

Brief Summary

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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.

Detailed Description

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Cognitive functions of patients with congestive heart failure (NYHA II-III) before (pretest) and after (posttest) cognitive-training intervention are investigated. Changes in cognitive functions are compared to changes in two control groups: 1) age and gender matched active control group 2) age and gender matched passive waiting list control group.

The neuropsychological test battery applied at pretest and posttest includes measures of episodic memory, working memory, short-term memory, executive functions, perceptual speed and intelligence. In addition, the investigators apply standardized questionnaires of self-assessed quality of life, cognitive functioning in daily life, selfcare, and psychological well-being (depression, anxiety and personality). Relevant physiological data such as ejection fraction, heartrate, N-terminal pro brain natriuretic peptide (NT-pro-BNP) as well as drug blood level are recorded.

Conditions

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Congestive Heart Failure Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pre-Test, Intervention, Post-Test, Follow-Up
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants were enrolled in Treatment-Group, Waitinglist-Group, or Shamtraining-Group

Study Groups

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Experimental group

Intervention: Cognitive Training

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

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

Active control group

Intervention: Test of general knowledge

Group Type ACTIVE_COMPARATOR

Test of general knowledge

Intervention Type BEHAVIORAL

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

Passive control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive training

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

Intervention Type BEHAVIORAL

Test of general knowledge

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Congestive heart failure
* NYHA II-III

Exclusion Criteria

* Psychosis
* Dementia
* Major depression
* Reanimation (\<3month)
* Patients with assist device system
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Stiftung für Herzforschung

OTHER

Sponsor Role collaborator

Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Sonja Wedegärtner

Dipl. Psych.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingrid Kindermann, PD Dr.med.

Role: STUDY_DIRECTOR

University Hospital, Saarland

Julia Karbach, Prof.

Role: STUDY_DIRECTOR

Goethe-Universität Frankfurt am Main

Sonja Wedegärtner, Dipl.Psych.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Saarland

Maxie Bunz, Dipl.Psych.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Saarland

Michael Böhm, Prof.

Role: STUDY_CHAIR

University Hospital, Saarland

Locations

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Department of Educational Science, Saarland University

Frankfurt am Main, Hesse, Germany

Site Status

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

Homburg, Saarland, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 32871668 (View on PubMed)

Other Identifiers

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CogTrain-HF

Identifier Type: -

Identifier Source: org_study_id

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