Heart Failure NYHA Class IIMemoir-HFNCT03035565
Cognitive Intervention to Improve Memory in Heart Failure Patients
A study testing Computerized Cognitive Training with Brain HQ and Computerized Crossword Puzzles in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Indiana University at 2 sites in United States.
Trial summary
Cognitive Intervention to Improve Memory in Heart Failure patients Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class I
- What is being tested?
- Computerized Cognitive Training with Brain HQ and Computerized Crossword Puzzles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2017to 30 Sep 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years of age
- Understands English
- Has access to a telephone
- Hears normal conversation
- For patients with hearing aids, able to wear and hear through headsets
- Diagnosis of chronic heart failure, stage C, NYHA I, II or III
Show all 9Show fewer
- Receiving guideline derived medical therapy
- Heart failure validated by echocardiography or other method in past 2 years
- Able to read a computer screen with or without glasses or lenses
Who cannot join
- History of drug or alcohol abuse or major psychiatric diagnosis present before the heart failure diagnosis
- Alzheimer or other dementia diagnosis or central nervous system degenerative disorder
- Terminal cancer
- Patients with baseline Montreal Cognitive Assessment (MoCA) score of less than 19
- Supplement Eligibility: First 144 patients randomized in the parent trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health
Indianapolis, Indiana, 46202
Methodist Hospital-Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
About this study
Cognitive Intervention to Improve Memory in Heart Failure patients
Read the detailed description
A three arm randomized controlled trial of 276 heart failure patients.
- Being tested
- Computerized Cognitive Training with Brain HQ, Computerized Crossword Puzzles
- Keywords
- Heart Failure, Cognition in Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Training with Brain HQBehavioural
Computerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
Computerized Crossword PuzzlesBehavioural
Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Training Brain HQ | Experimental | Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks Receives: Behavioral: Computerized Cognitive Training with Brain HQ |
| Computerized Crossword Puzzles | Active comparator | General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks Receives: Behavioral: Computerized Crossword Puzzles |
| Usual Care | No intervention | No computerized cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Measured: At 8 months
Change in serum brain derived neurotrophic factor ( BDNF) Level
Co-Primary Outcome
Measured: At 8 months
Secondary outcomes (4)
Change in working memory as measured by CogState One Back Accuracy Task
Change in working memory as measured by CogState One Back Accuracy Task
Measured: At 8 months
Change in instrumental activities of daily living as measured by Everyday Problems Test
Change in instrumental activities of daily living as measured by Everyday Problems Test
Measured: At 8 months
Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
Measured: At 8 months
Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs
Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs
Measured: At 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start22 Feb 2017
- Primary completion6 Nov 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IIStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Pressler, Indiana University
- Investigators
- Susan J Pressler, PhD, RN, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035565
- Sponsor's protocol ID
- R01NR016116-01A1
- Acronym
- Memoir-HF
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2017
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pressler SJ, Giordani B, Titler M, Gradus-Pizlo I, Smith D, Dorsey SG, Gao S, Jung M. Design and Rationale of the Cognitive Intervention to Improve Memory in Heart Failure Patients Study. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):344-355. doi: 10.1097/JCN.0000000000000463.
PubMed 29601367Halloway S, Jung M, Yeh AY, Liu J, McAdams E, Barley M, Dorsey SG, Pressler SJ. An Integrative Review of Brain-Derived Neurotrophic Factor and Serious Cardiovascular Conditions. Nurs Res. 2020 Sep/Oct;69(5):376-390. doi: 10.1097/NNR.0000000000000454.
PubMed 32555009Pressler SJ, Jung M, Gradus-Pizlo I, Titler MG, Smith DG, Gao S, Lake KR, Burney H, Clark DG, Wierenga KL, Dorsey SG, Giordani B. Randomized Controlled Trial of a Cognitive Intervention to Improve Memory in Heart Failure. J Card Fail. 2022 Apr;28(4):519-530. doi: 10.1016/j.cardfail.2021.10.008. Epub 2021 Nov 8.
PubMed 34763080Smith AB, Jung M, Pressler SJ, Mocci E, Dorsey SG. Differential Gene Expression Among Patients With Heart Failure Experiencing Pain. Nurs Res. 2023 May-Jun 01;72(3):175-184. doi: 10.1097/NNR.0000000000000648. Epub 2023 Feb 26.
PubMed 36920122
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Intervention to Improve Memory in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03035565
- Acronym / sponsor ID
- Memoir-HF / R01NR016116-01A1
- Keywords
- Heart Failure, Cognition in Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 30 Jan 2017 (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.
Cognitive Intervention to Improve Memory in Heart Failure patients
Detailed description
A three arm randomized controlled trial of 276 heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Training Brain HQ | Experimental | Behavioral: Computerized Cognitive Training with Brain HQComputerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks |
| Computerized Crossword Puzzles | Active comparator | Behavioral: Computerized Crossword PuzzlesGeneral cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks |
| Usual Care | No intervention | –No computerized cognitive intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 21 years of age
- Understands English
- Has access to a telephone
- Hears normal conversation
- For patients with hearing aids, able to wear and hear through headsets
Key exclusion criteria (5 listed)
- History of drug or alcohol abuse or major psychiatric diagnosis present before the heart failure diagnosis
- Alzheimer or other dementia diagnosis or central nervous system degenerative disorder
- Terminal cancer
- Patients with baseline Montreal Cognitive Assessment (MoCA) score of less than 19
- Supplement Eligibility: First 144 patients randomized in the parent trial.
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 |
|---|---|---|
| Computerized Cognitive Training with Brain HQComputerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks | Behavioural | Computerized Cognitive Training Brain HQ |
| Computerized Crossword PuzzlesComputerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks | Behavioural | Computerized Crossword Puzzles |
Primary outcome
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Time frame: At 8 months
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Change in serum brain derived neurotrophic factor ( BDNF) Level
Time frame: At 8 months
Co-Primary Outcome
4 secondary outcomes
Change in working memory as measured by CogState One Back Accuracy Task
Time frame: At 8 months
Change in instrumental activities of daily living as measured by Everyday Problems Test
Time frame: At 8 months
Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
Time frame: At 8 months
Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs
Time frame: At 8 months
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 17 Feb 2023.
- Background: PubMed 29601367Pressler SJ, Giordani B, Titler M, Gradus-Pizlo I, Smith D, Dorsey SG, Gao S, Jung M. Design and Rationale of the Cognitive Intervention to Improve Memory in Heart Failure Patients Study. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):344-355. doi: 10.1097/JCN.0000000000000463.
- Background: PubMed 32555009Halloway S, Jung M, Yeh AY, Liu J, McAdams E, Barley M, Dorsey SG, Pressler SJ. An Integrative Review of Brain-Derived Neurotrophic Factor and Serious Cardiovascular Conditions. Nurs Res. 2020 Sep/Oct;69(5):376-390. doi: 10.1097/NNR.0000000000000454.
- Results publication: PubMed 34763080Pressler SJ, Jung M, Gradus-Pizlo I, Titler MG, Smith DG, Gao S, Lake KR, Burney H, Clark DG, Wierenga KL, Dorsey SG, Giordani B. Randomized Controlled Trial of a Cognitive Intervention to Improve Memory in Heart Failure. J Card Fail. 2022 Apr;28(4):519-530. doi: 10.1016/j.cardfail.2021.10.008. Epub 2021 Nov 8.
- Derived from this study: PubMed 36920122Smith AB, Jung M, Pressler SJ, Mocci E, Dorsey SG. Differential Gene Expression Among Patients With Heart Failure Experiencing Pain. Nurs Res. 2023 May-Jun 01;72(3):175-184. doi: 10.1097/NNR.0000000000000648. Epub 2023 Feb 26.
- Individual participant dataSharing planned: Yes
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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.
Susan J Pressler, PhD, RN principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training with Brain HQ and Computerized Crossword Puzzles in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Indiana University at 2 sites in United States.
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 9 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 17 Feb 2023. 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 United States. 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?
Change in delayed recall memory as measured by Hopkins Verbal Learning Test (time frame: At 8 months). The study lists 2 primary outcomes in all. 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 NCT03035565, which also lists 4 linked publications.
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 17 Feb 2023.