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Completed

NCT Number: NCT02415517

Cognitive Training in Heart Failure Study (CogTrain-HF)

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Heart Diseases Heart Failure Mental Disorders Neurocognitive Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Educational Science, Saarland University, Frankfurt am Main, Hesse, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Congestive heart failure
  • NYHA II-III

Exclusion criteria

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

Treatment and study plan

Cognitive training

Behavioral

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

Test of general knowledge

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Compliance with medication

    Time frame: 5 weeks

    Compliance with medication measured as serum level of medication and heart failure-specific self-care duties.

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Collaborators

  • Deutsche Stiftung für Herzforschung

Registry information

Acronym: CogTrain-HF

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2015
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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