Back to results

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

Primary Purpose

Congestive Heart Failure, Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Cognitive training

Test of general knowledge

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Cognitive training, Cognitive impairment, Heart failure, Cognition

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Congestive heart failure
NYHA II-III

Exclusion Criteria:

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

Sites / Locations

Department of Educational Science, Saarland University
Clinic for Internal Medicine, Cardioloy, Angioloy, and Internal Intensive Care Medicine, Saarland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Experimental group

Active control group

Passive control group

Arm Description

Intervention: Cognitive Training

Intervention: Test of general knowledge

No intervention

Outcomes

Primary Outcome Measures

Training effects

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

Secondary Outcome Measures

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.

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.

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.

Compliance with medication

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

Full Information

NCT ID

NCT02415517

First Posted

April 2, 2015

Last Updated

March 24, 2020

Sponsor

Universität des Saarlandes

Collaborators

Deutsche Stiftung für Herzforschung

1. Study Identification

Unique Protocol Identification Number

NCT02415517

Brief Title

Cognitive Training in Heart Failure Study (CogTrain-HF)

Acronym

CogTrain-HF

Official Title

Cognitive Training in Heart Failure Study (CogTrain-HF)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

June 3, 2019 (Actual)

Study Completion Date

December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universität des Saarlandes

Collaborators

Deutsche Stiftung für Herzforschung

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congestive Heart Failure, Cognitive Impairment

Keywords

Cognitive training, Cognitive impairment, Heart failure, Cognition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Pre-Test, Intervention, Post-Test, Follow-Up

Masking

Participant

Masking Description

Participants were enrolled in Treatment-Group, Waitinglist-Group, or Shamtraining-Group

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Intervention: Cognitive Training

Arm Title

Active control group

Arm Type

Active Comparator

Arm Description

Intervention: Test of general knowledge

Arm Title

Passive control group

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Behavioral

Intervention Name(s)

Cognitive training

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Test of general knowledge

Intervention Description

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

Primary Outcome Measure Information:

Title

Training effects

Description

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

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Transfer effects

Description

Time Frame

5 weeks

Title

Changes in quality of life and psychological well-being

Description

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

Time Frame

5 weeks

Title

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

Description

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.

Time Frame

6 month

Title

Compliance with medication

Description

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

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Congestive heart failure NYHA II-III Exclusion Criteria: Psychosis Dementia Major depression Reanimation (<3month) Patients with assist device system

Overall Study Officials: