Cognitive Training in Heart Failure Study (CogTrain-HF)

Cognitive Impairment Clinical Trial

— CogTrain-HF  

Official title:

Cognitive Training in Heart Failure Study (CogTrain-HF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415517
• Other study ID #: CogTrain-HF
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 4, 2019

Study information

• Verified date: March 2020
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 4, 2019
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Congestive heart failure

• NYHA II-III

Exclusion Criteria:

• Psychosis

• Dementia

• Major depression

• Reanimation (<3month)

• Patients with assist device system

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Congestive Heart Failure
• Heart Failure

Intervention

Behavioral:
• Cognitive training
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
Training of general knowledge on computer. Six sessions with different topics.

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Saarland University	Deutsche Stiftung für Herzforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Compliance with medication	Compliance with medication measured as serum level of medication and heart failure-specific self-care duties.	5 weeks