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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universität des Saarlandes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Deutsche Stiftung für Herzforschung

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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