Clinical trial NCT02415517: Cognitive Training in Heart Failure Study (CogTrain-HF)
Official title: Cognitive Training in Heart Failure Study (CogTrain-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Cognitive Impairment
Keywords: Cognitive training
Cognitive impairment
Heart failure
Cognition
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: Deutsche Stiftung für Herzforschung
First posted: 2015-04-14
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre-Test, Intervention, Post-Test, Follow-Up
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Congestive heart failure
* NYHA II-III

Exclusion Criteria:

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

Primary outcomes:
measure: Training effects
timeFrame: 3 weeks
Secondary outcomes:
measure: Transfer effects
timeFrame: 5 weeks
measure: Changes in quality of life and psychological well-being
timeFrame: 5 weeks
measure: Long-term benefits of cognitive training in patients with congestive heart failure.
timeFrame: 6 month
measure: Compliance with medication
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of Educational Science, Saarland University
state: Hessen
city: Homburg
country: Germany
facility: Clinic for Internal Medicine, Cardioloy, Angioloy, and Internal Intensive Care Medicine, Saarland University Hospital
state: Saarland
Study officials:
affiliation: University Hospital, Saarland
name: Ingrid Kindermann, PD Dr.med.
role: STUDY_DIRECTOR
affiliation: Goethe-Universität Frankfurt am Main
name: Julia Karbach, Prof.
role: STUDY_DIRECTOR
affiliation: University Hospital, Saarland
name: Sonja Wedegärtner, Dipl.Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Saarland
name: Maxie Bunz, Dipl.Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Saarland
name: Michael Böhm, Prof.
role: STUDY_CHAIR
References:
citation: Wedegartner SM, Schwantke I, Kindermann I, Karbach J. Predictors of heart-focused anxiety in patients with stable heart failure. J Affect Disord. 2020 Nov 1;276:380-387. doi: 10.1016/j.jad.2020.06.065. Epub 2020 Jul 15.