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Cognitive Training in Heart Failure Study (CogTrain-HF)

Not Applicable
Completed
Conditions
Congestive Heart Failure
Cognitive Impairment
Interventions
Behavioral: Test of general knowledge
Behavioral: Cognitive training
Registration Number
NCT02415517
Lead Sponsor
Universität des Saarlandes
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
107
Inclusion Criteria
  • Congestive heart failure
  • NYHA II-III
Exclusion Criteria
  • Psychosis
  • Dementia
  • Major depression
  • Reanimation (<3month)
  • Patients with assist device system

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Active control groupTest of general knowledgeIntervention: Test of general knowledge
Experimental groupCognitive trainingIntervention: Cognitive Training
Primary Outcome Measures
NameTimeMethod
Training effects3 weeks

Improvement in performance in the last trainingssession compared with the performance in the first trainingssession. Performance will be assessed by computesoftware.

Secondary Outcome Measures
NameTimeMethod
Transfer effects5 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.

Changes in quality of life and psychological well-being5 weeks

Changes in quality of life and psychological well-being as the result of cognitive training measured by psychological questionnaires and tests.

Long-term benefits of cognitive training in patients with congestive heart failure.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.

Compliance with medication5 weeks

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

Trial Locations

Locations (2)

Department of Educational Science, Saarland University

🇩🇪

Frankfurt am Main, Hessen, Germany

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

🇩🇪

Homburg, Saarland, Germany

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