Congestive Heart FailureCogTrain-HFNCT02415517
Cognitive Training in Heart Failure Study (CogTrain-HF)
A study testing Cognitive training and Test of general knowledge in people with Congestive Heart Failure and Cognitive Impairment, run by Universität des Saarlandes at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Congestive Heart Failure, Cognitive Impairment
- What is being tested?
- Cognitive training and Test of general knowledge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2014to 4 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Congestive heart failure
- NYHA II-III
Who cannot join
- Psychosis
- Dementia
- Major depression
- Reanimation (<3month)
- Patients with assist device system
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Educational Science, Saarland University
Frankfurt am Main, Hesse, 60323
Clinic for Internal Medicine, Cardioloy, Angioloy, and Internal Intensive Care Medicine, Saarland University Hospital
Homburg, Saarland, 66421
About this study
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.
Read the 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.
- Conditions
- Congestive Heart Failure, Cognitive Impairment
- Being tested
- Cognitive training, Test of general knowledge
- Keywords
- Cognitive training, Cognitive impairment, Heart failure, Cognition
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Cognitive training on computer. Six sessions with different tasks: "Tiere merken" \& "Räumlich visuelles Training" (application BrainTwister) and "Taskswitching" (programmed with eprime)
Test of general knowledgeBehavioural
Training of general knowledge on computer. Six sessions with different topics.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Intervention: Cognitive Training Receives: Behavioral: Cognitive training |
| Active control group | Active comparator | Intervention: Test of general knowledge Receives: Behavioral: Test of general knowledge |
| Passive control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training effects
Improvement in performance in the last trainingssession compared with the performance in the first trainingssession. Performance will be assessed by computesoftware.
Measured: 3 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 6 month
Compliance with medication
Compliance with medication measured as serum level of medication and heart failure-specific self-care duties.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJan 2014
- Primary completion3 Jun 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pre-Test, Intervention, Post-Test, Follow-Up
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Responsible party
- Principal investigator, Sonja Wedegärtner, Universität des Saarlandes
- Investigators
- Ingrid Kindermann, PD Dr.med., Study director, University Hospital, SaarlandJulia Karbach, Prof., Study director, Goethe-Universität Frankfurt am MainSonja Wedegärtner, Dipl.Psych., Principal investigator, University Hospital, SaarlandMaxie Bunz, Dipl.Psych., Principal investigator, University Hospital, SaarlandMichael Böhm, Prof., Study chair, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415517
- Sponsor's protocol ID
- CogTrain-HF
- Acronym
- CogTrain-HF
- Status last verified
- Mar 2020
- First submitted
- 2 Apr 2015
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32871668
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in Heart Failure Study (CogTrain-HF)
- ClinicalTrials.gov ID
- NCT02415517
- Acronym / sponsor ID
- CogTrain-HF / CogTrain-HF
- Conditions
- Congestive Heart Failure, Cognitive Impairment
- Keywords
- Cognitive training, Cognitive impairment, Heart failure, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Study start
- Jan 2014
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Pre-Test, Intervention, Post-Test, Follow-Up
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Cognitive trainingIntervention: Cognitive Training |
| Active control group | Active comparator | Behavioral: Test of general knowledgeIntervention: Test of general knowledge |
| Passive control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Congestive heart failure
- NYHA II-III
Key exclusion criteria (5 listed)
- Psychosis
- Dementia
- Major depression
- Reanimation (<3month)
- Patients with assist device system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingCognitive training on computer. Six sessions with different tasks: "Tiere merken" \& "Räumlich visuelles Training" (application BrainTwister) and "Taskswitching" (programmed with eprime) | Behavioural | Experimental group |
| Test of general knowledgeTraining of general knowledge on computer. Six sessions with different topics. | Behavioural | Active control group |
Primary outcome
Training effects
Time frame: 3 weeks
Improvement in performance in the last trainingssession compared with the performance in the first trainingssession. Performance will be assessed by computesoftware.
4 secondary outcomes
Transfer effects
Time frame: 5 weeks
Changes in quality of life and psychological well-being
Time frame: 5 weeks
Long-term benefits of cognitive training in patients with congestive heart failure.
Time frame: 6 month
Compliance with medication
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 32871668Wedegartner 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.
- Individual participant dataSharing planned: Yes
Related trials for Congestive Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Kindermann, PD Dr.med. study director
University Hospital, Saarland
Julia Karbach, Prof. study director
Goethe-Universität Frankfurt am Main
Sonja Wedegärtner, Dipl.Psych. principal investigator
University Hospital, Saarland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Test of general knowledge in people with Congestive Heart Failure and Cognitive Impairment, run by Universität des Saarlandes at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training effects (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.