Cognitive Training in Heart Failure Study (CogTrain-HF)

Study Overview
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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.

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

Conditions
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Congestive Heart Failure, Cognitive Impairment

Intervention / Treatment
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* Behavioral: Cognitive training
* Behavioral: Test of general knowledge


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pre-Test, Intervention, Post-Test, Follow-Up
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfer effects | 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 | 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. | 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 | Compliance with medication measured as serum level of medication and heart failure-specific self-care duties. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive training, Cognitive impairment, Heart failure, Cognition