Cognitive Training in Heart Failure Study (CogTrain-HF) (CogTrain-HF)

March 24, 2020 updated by: Sonja Wedegärtner, Universität des Saarlandes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60323
        • Department of Educational Science, Saarland University
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Clinic for Internal Medicine, Cardioloy, Angioloy, and Internal Intensive Care Medicine, Saarland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Congestive heart failure
  • NYHA II-III

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Intervention: Cognitive Training
Behavioral: Cognitive training
Cognitive training on computer. Six sessions with different tasks: "Tiere merken" & "Räumlich visuelles Training" (application BrainTwister) and "Taskswitching" (programmed with eprime)
Active Comparator: Active control group
Intervention: Test of general knowledge
Behavioral: Test of general knowledge
Training of general knowledge on computer. Six sessions with different topics.
No Intervention: Passive control group
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Training effects
Time Frame: 3 weeks
Improvement in performance in the last trainingssession compared with the performance in the first trainingssession. Performance will be assessed by computesoftware.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfer effects
Time Frame: 5 weeks
Transfer effects are measured by comparing cognitive functions in patients with congestive heart failure before and after cognitive training. Cognitive functions will be assessed by different paper-and-pencil tests and computerbased tests.
5 weeks
Changes in quality of life and psychological well-being
Time Frame: 5 weeks
Changes in quality of life and psychological well-being as the result of cognitive training measured by psychological questionnaires and tests.
5 weeks
Long-term benefits of cognitive training in patients with congestive heart failure.
Time Frame: 6 month
Follow-up assessment by 6 months after training. Long-term benefits will be measured by different paper-and-pencil tests and computerbased tests as well as psychological questionnaires and tests.
6 month
Compliance with medication
Time Frame: 5 weeks
Compliance with medication measured as serum level of medication and heart failure-specific self-care duties.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität des Saarlandes

Collaborators

Deutsche Stiftung für Herzforschung

Investigators

  • Study Director: Ingrid Kindermann, PD Dr.med., University Hospital, Saarland
  • Study Director: Julia Karbach, Prof., Goethe-Universität Frankfurt am Main
  • Principal Investigator: Sonja Wedegärtner, Dipl.Psych., University Hospital, Saarland
  • Principal Investigator: Maxie Bunz, Dipl.Psych., University Hospital, Saarland
  • Study Chair: Michael Böhm, Prof., University Hospital, Saarland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 3, 2019

Study Completion (Actual)

December 4, 2019

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CogTrain-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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